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Medical Device Good Manufacturing Practice (GMP) in CHina

Mon, 05 Jan 2026 16:51:11 GMT

Medical Device Good Manufacturing Practice (GMP)
(Order No. 107 of 2025)

Chapter I General Provisions

Article 1

In order to regulate the quality management of medical device manufacturing and ensure the safety and effectiveness of medical devices, this Regulation is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices , the Measures for the Registration and Filing of Medical Devices , the Measures for the Registration and Filing of In Vitro Diagnostic Reagents , the Measures for the Supervision and Administration of Medical Device Manufacturing, and other relevant laws and regulations.

Article 2

Medical device registrants, filing entities, and entrusted manufacturing enterprises (hereinafter collectively referred to as “enterprises”) shall comply with this Regulation during activities including medical device design and development, manufacturing, quality control and product release, sales, and after-sales service.

Article 3

Enterprises shall establish, implement, and maintain a quality management system (QMS) appropriate to the medical devices they manufacture, in accordance with the requirements of this Regulation, and ensure its effective operation.

The quality management system shall cover activities such as entrusted research and development, entrusted manufacturing, outsourced processing, and entrusted testing.

Article 4

Enterprises shall apply risk management principles throughout the entire operation of the quality management system. Control measures adopted shall be commensurate with the risks associated with the product.

Article 5

Enterprises shall operate with honesty and integrity. Any falsification or deceptive conduct is prohibited.

Article 6

Enterprises are encouraged to promote digital and intelligent transformation, improve manufacturing and quality management efficiency, and facilitate high-quality development of the medical device industry.

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Chapter II Quality Assurance

Article 7

Enterprises shall fulfill their primary responsibility for medical device quality and safety. They shall establish quality objectives that meet medical device quality management requirements and systematically implement all requirements related to medical device safety, effectiveness, and controllable quality throughout the operation of the quality management system, ensuring that quality objectives are fully understood and effectively achieved.

Article 8

Enterprises shall provide sufficient and appropriate resources—including personnel, premises, facilities, and equipment—to achieve quality objectives. Personnel at all levels shall participate in activities to achieve quality objectives and assume corresponding responsibilities.

Article 9

Enterprises shall establish a quality assurance system and maintain complete quality management system documentation to ensure effective operation of the QMS.

The quality assurance system shall ensure that:

1. Medical device design and development, manufacturing management, and quality control activities comply with this Regulation;

2. Management responsibilities are clearly defined;

3. Procured and used raw materials are correct and appropriate;

4. In-process products are effectively controlled;

5. Verification and validation activities meet specified requirements;

6. Manufacturing and testing are conducted strictly in accordance with established procedures;

7. Each batch (or unit) of product is released only after review and approval;

8. Measures are in place to ensure product quality during storage, transportation, and installation;

9. Entrusted R&D, entrusted manufacturing, outsourced processing, and entrusted testing activities are under controlled conditions.

Article 10

Enterprises shall establish change control procedures. Based on the risk level of changes affecting the safety, effectiveness, and quality controllability of medical devices, as well as relevant regulatory requirements, enterprises shall determine the type of change management, conduct change reviews, and obtain appropriate approval prior to implementation.

Where necessary, verification and validation shall be performed to ensure that changes do not adversely affect product safety, effectiveness, or quality controllability.

Article 11

Enterprises shall achieve continuous improvement of the quality management system, processes, and product quality through activities including quality data monitoring, change management, adverse event monitoring, quality risk management reviews, corrective and preventive actions (CAPA), internal audits, and management reviews.

Article 12

Enterprises shall establish a quality risk management system. Based on laws, regulations, rules, standards, scientific knowledge, and experience, enterprises shall assess quality risks throughout the entire product realization process, verify and implement risk control measures, and ensure effective control of product quality risks.

Article 13

Enterprises shall collect quality risk information throughout the entire product life cycle and regularly conduct quality risk management reviews to ensure the continued effectiveness of quality risk control measures.

Chapter III Organization and Personnel

Article 14

Enterprises shall establish an organizational structure appropriate for medical device manufacturing, clearly define the responsibilities and authorities of each department, and clearly define quality management functions.

The heads of the production management department and the quality management department shall not concurrently hold both positions.

Article 15

Enterprises shall establish a quality management department appropriate to the products they manufacture. The quality management department shall participate in all activities related to product quality and shall be responsible for reviewing documents related to this Regulation.

The quality management department shall independently perform quality assurance and quality control responsibilities and shall have veto authority over product quality.

Article 16

Enterprises shall employ an adequate number of professional and technical personnel, management personnel, production operators, and full-time inspection personnel with appropriate qualifications (including education, training, and practical experience).

The responsibilities of each position shall be clearly defined, with no omissions; overlapping responsibilities shall be clearly specified.

Article 17

Enterprises shall appoint key personnel appropriate to the products they manufacture. Key personnel shall include at least: the legal representative, principal responsible person, management representative, head of the production management department, head of the quality management department, and product release reviewer.

The principal responsible person, management representative, head of the production management department, head of the quality management department, and product release reviewer shall be full-time employees of the enterprise.

Key personnel shall be familiar with medical device laws and regulations, possess practical experience in quality management, and be capable of making correct judgments and handling practical issues in production and quality management.

Article 18

The legal representative and principal responsible person shall bear overall responsibility for medical device manufacturing and shall perform the following duties:

1. Organize the formulation of the enterprise’s quality policy and quality objectives;

2. Ensure the availability of human resources, infrastructure, and work environment required for effective operation of the quality management system;

3. Organize management reviews, regularly evaluate the operation of the quality management system, and promote continuous improvement;

4. Ensure that the management representative, head of the quality management department, and product release reviewer independently perform their duties without interference from internal factors;

5. Organize production in accordance with relevant laws, regulations, rules, mandatory standards, and registered or filed product technical requirements.

Article 19

Enterprises shall appoint a management representative from senior management.

For Class II and Class III medical device enterprises, the management representative shall possess a bachelor’s degree or above in a medical device-related discipline, or an intermediate or higher professional technical title.

For Class I medical device enterprises, the management representative shall possess a junior college degree or above in a medical device-related discipline.

In principle, the management representative shall have at least three years of experience in medical device quality management, manufacturing, or technical management, be familiar with product manufacturing and quality management, and have strong capability to perform duties.

The management representative shall at least perform the following duties:

1. Ensure implementation of relevant laws, regulations, rules, mandatory standards, and registered or filed product technical requirements;

2. Establish, maintain, and ensure effective operation of a quality management system appropriate to the products manufactured;

3. Ensure products meet release requirements and organize post-market quality information collection;

4. Organize self-inspection of the quality management system, adverse event monitoring, and recall activities, and regularly report QMS operation status and improvement needs to the legal representative and principal responsible person;

5. Cooperate with supervision and inspection by drug regulatory authorities and organize timely corrective actions for identified issues.

Chapter III Organization and Personnel (continued)

Article 20

For Class II and Class III medical device enterprises, the head of the quality management department shall possess a bachelor’s degree or above in a medical device-related discipline or an intermediate or higher professional technical title.

For Class I medical device enterprises, the head of the quality management department shall possess a junior college degree or above in a medical device-related discipline.

The head of the quality management department shall have at least three years of experience in medical device manufacturing or quality management.

The head of the quality management department shall perform the following duties:

1. Ensure that the manufacturing and inspection of raw materials and products comply with relevant laws, regulations, rules, mandatory standards, and registered or filed product technical requirements;

2. Organize product release review;

3. Ensure that all major deviations and nonconformities during manufacturing are investigated and handled promptly and effectively;

4. Organize post-market product quality management activities, ensuring that all quality-related returns, complaints, and adverse events are investigated and handled promptly and effectively;

5. Ensure completion of annual product quality review and analysis;

6. Ensure personnel within the department receive relevant training and master applicable regulations, theoretical knowledge, and practical skills;

7. Be responsible for other activities related to product quality.

Article 21

The head of the production management department shall possess a junior college degree or above in a medical device-related discipline and have at least three years of experience in medical device manufacturing or quality management.

The head of the production management department shall perform the following duties:

1. Ensure production is organized in accordance with manufacturing process specifications and work instructions;

2. Ensure production records are truthful, accurate, complete, timely, and traceable;

3. Organize maintenance of premises, facilities, and equipment to ensure proper operating condition;

4. Ensure personnel in the department receive appropriate training and possess knowledge and operational skills suitable for their positions;

5. Be responsible for other activities related to product manufacturing.

Article 22

The product release reviewer shall be personnel from the quality management department or other higher-level quality management personnel.

The product release reviewer shall receive training related to product release, possess product release review capability, and independently perform product release review duties.

Article 23

All personnel engaged in activities affecting product quality shall receive training appropriate to their job requirements, including regulations, job responsibilities, and practical operational skills, to ensure they clearly understand their responsibilities and relevant requirements and possess appropriate theoretical knowledge and practical skills.

Enterprises shall designate a department or individual responsible for training management, establish training procedures, develop training plans, retain training records, and evaluate training effectiveness.

Article 24

For personnel engaged in activities affecting product quality, enterprises shall manage personnel health based on product characteristics and establish health records.

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Chapter IV Premises and Facilities

Article 25

The site selection, design, layout, construction, renovation, and maintenance of premises shall meet medical device manufacturing requirements, minimize contamination, cross-contamination, mix-ups, and errors, and facilitate cleaning, operation, and maintenance.

Article 26

Enterprises shall reasonably design, lay out, and use premises and facilities based on product characteristics, process flow, and required cleanliness levels.

Production environments shall be clean and orderly, with appropriate lighting, temperature, humidity, and ventilation controls that meet product quality and relevant technical standard requirements.

Article 27

The design and installation of premises and facilities shall effectively prevent the entry of insects or other animals. Necessary protective measures shall be implemented according to product characteristics.

Maintenance and repair activities of premises and facilities shall not adversely affect product quality.

Article 28

Production areas shall have sufficient space appropriate to the products manufactured and production scale.

Where multiple production lines are present in the same area, effective measures shall be taken to prevent mix-ups and errors.

Article 29

Warehousing areas shall meet storage requirements for raw materials, in-process products, and finished products. Materials shall be stored according to inspection status, conformity status, nonconformity, return, or recall, to prevent mix-ups and errors and facilitate inspection and monitoring.

Acceptance, storage, and management of toxic, flammable, explosive, or other hazardous materials shall comply with national regulations.

Article 30

Enterprises shall be equipped with inspection areas and facilities appropriate to the scale, product types, and inspection requirements.

Article 31

Enterprises shall configure appropriate facilities based on product characteristics, manufacturing processes, and external environmental factors, such as HVAC purification systems, process water systems, process gas systems, and electrostatic protection facilities.

Such facilities shall be qualified and subject to routine monitoring and maintenance to ensure fitness for intended use.

Article 32

Where cleanliness levels are required for the production environment:

• The differential pressure between clean and non-clean areas shall be greater than 10 Pa;

• The differential pressure between areas of different cleanliness levels shall be greater than 5 Pa.

Where necessary, appropriate pressure gradients shall also be maintained between functional areas (rooms) of the same cleanliness level.

Operational areas generating large amounts of dust, fumes, or toxic substances shall be maintained under relative negative pressure. Exhaust gases discharged outdoors shall be purified and meet applicable requirements.

Article 33

Where information systems are used in manufacturing, inspection, or storage, enterprises shall be equipped with hardware facilities and software operating environments suitable for intended use and shall take appropriate measures to prevent external interference.

Article 34

Production, inspection, and storage areas shall not serve as direct passageways for non-authorized personnel.

Appropriate measures shall be taken to prevent unauthorized access.

Article 35

Enterprises shall retain documentation related to premises and facilities, including but not limited to overall site layout plans, production area distribution diagrams, operating instructions, and maintenance procedures.

Chapter V Equipment

Article 36

Enterprises shall be equipped with production equipment, inspection instruments and equipment, tooling and fixtures appropriate to the products manufactured and production scale, and shall ensure their effective operation.

The design, selection, installation, maintenance, and repair of equipment and instruments shall be suitable for their intended use and facilitate operation, cleaning, and maintenance.

Article 37

Enterprises shall establish equipment and instrument files, including but not limited to procurement, installation, and qualification documentation and records.

Article 38

Enterprises shall establish operating procedures for the use, maintenance, and repair of major equipment and instruments and retain relevant records to ensure traceability of related activities.

Article 39

Major equipment, instruments, and tooling shall be clearly identified with numbers and names.

Where abnormal conditions occur, abnormal status identification shall be applied to prevent unintended use.

Article 40

Enterprises shall periodically calibrate or verify major equipment and instruments in accordance with operating procedures and calibration or verification plans.

The calibration range shall cover the actual range of use.

Enterprises shall be equipped with appropriate measuring instruments whose range and accuracy meet usage requirements, and the validity period of calibration or verification shall be clearly identified.

Calibration or verification records shall be retained.

Article 41

Equipment and instruments that have undergone modification or major repair shall be re-qualified before use.

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Chapter VI Documentation and Data Management

Article 42

Enterprises shall establish and maintain quality management system documentation, including quality policy and quality objectives, quality manuals, procedure documents, technical documents and records, and other documents required by regulations.

The quality manual shall define the quality management system.

Procedure documents shall be developed based on actual needs of design and development, manufacturing, and quality management activities and shall include all procedures required by this Regulation.

Technical documents shall include product technical requirements and related standards, manufacturing process specifications, work instructions, inspection and test procedures, and installation and service procedures.

Article 43

Enterprises shall establish document control procedures to systematically design, draft, review, approve, issue, and retain quality management system documents, and shall meet the following requirements:

1. Document drafting, revision, review, approval, replacement or withdrawal, copying, retention, and destruction shall be managed in accordance with document control procedures, with corresponding distribution, replacement, withdrawal, and destruction records; appropriate control methods shall be defined according to document use and type;

2. Document revisions or updates shall be reviewed and approved, and document revision status shall be identifiable;

3. Distributed and used documents shall be appropriate versions; withdrawn or obsolete documents shall be clearly identified to prevent misuse;

4. Retention periods for obsolete quality management system documents (such as technical documents) shall be defined to support product servicing and quality responsibility traceability.

Article 44

Enterprises shall designate departments or personnel responsible for identifying changes in external documents such as medical device-related laws, regulations, standards, and guidelines, and shall promptly update quality management system documentation accordingly.

Article 45

Enterprises shall establish record control procedures, including identification, storage, retrieval, retention periods, and disposition requirements, and shall meet the following requirements:

1. Records shall ensure traceability of design and development, manufacturing, quality control, and product release activities;

2. Records shall be truthful, accurate, complete, timely, clear, easily identifiable and retrievable, and protected from damage or loss;

3. Records shall not be arbitrarily altered or destroyed; where changes are necessary, reasons for change, the person making the change, and the date shall be recorded, and original information shall remain legible;

4. Record retention periods shall be at least consistent with the service life of the medical device as defined by the enterprise or meet regulatory requirements, and shall be no less than two years from the date of product release.

Article 46

Where computerized systems are used, enterprises shall ensure that electronic records or data are authentic, accurate, complete, timely, and traceable, and shall meet the following requirements:

1. User access controls shall be established to effectively control permissions that may affect the authenticity and accuracy of electronic records or data;

2. Modification or deletion of electronic records or data shall be performed only by authorized personnel, and modification or deletion records shall be retained;

3. Electronic records or data shall be backed up, with retention periods not less than those specified for records in this Chapter, and shall remain accessible during the retention period;

4. Where electronic signatures are used, they shall comply with relevant laws and regulations.

Chapter VII Design and Development

Article 47

Enterprises shall establish design and development control procedures, divide design and development into stages, and define activities and related documentation control requirements for planning, input, output, verification, validation, transfer, change, and review.

Design and development of medical devices shall be planned and controlled throughout the entire process.

Article 48

Enterprises shall integrate risk management principles throughout the entire process from design and development to product realization, establish documented requirements, apply appropriate risk management methods and tools, and retain relevant records.

Article 49

Enterprises shall plan design and development activities based on product characteristics and clearly define the specific activities to be conducted at each stage, including design and development input, output, transfer, verification, and validation.

A design and development plan shall be established, specifying applicable verification, validation, transfer, change, and review activities and output requirements for each stage, defining departmental responsibilities and interfaces.

The design and development plan shall be reviewed and approved and periodically reviewed during implementation.

Article 50

Design and development inputs shall at least include requirements for functionality, performance, safety, applicable regulations and standards, and risk control measures determined based on user needs and intended use.

Design and development input requirements shall be clear and complete and shall be reviewed and approved.

Article 51

Design and development outputs shall meet the corresponding input requirements.

Design and development outputs shall at least include information required for purchasing, manufacturing, inspection, use, and servicing, as well as product technical requirements.

Design and development outputs shall be verified and approved.

Article 52

Enterprises shall carry out design and development transfer activities in conjunction with product characteristics to ensure that manufacturing environment requirements, raw material controls, manufacturing processes, and quality control procedures derived from design outputs are verified and suitable for commercial production.

Design transfer shall focus on identification and validation/verification of key processes and special processes.

Article 53

Enterprises shall conduct reviews at appropriate stages of design and development to continuously evaluate the ability of design outputs to meet input requirements, identify issues, and propose necessary improvement measures.

Article 54

Enterprises shall verify design and development to ensure that design outputs meet design input requirements.

Verification documentation shall be retained, including at least verification plans, reports, results, conclusions, and process records.

Article 55

Enterprises shall validate design and development to ensure that the product meets specified use requirements or intended use.

Design validation may be conducted through clinical evaluation or non-clinical evaluation.

Where clinical trials are conducted, they shall comply with medical device clinical trial requirements.

Article 56

Enterprises shall identify and assess the impact of design and development changes.

Where necessary, changes shall be verified and validated and shall be approved prior to implementation.

Article 57

Enterprises shall establish design and development documentation, including records generated or referenced during the design and development process, to ensure traceability of all design outputs and related activities.

Article 58

Where design and development of medical devices is entrusted to a third party, the entrusting party shall evaluate the contractor’s R&D capability and ongoing technical support capability.

A written agreement shall be signed defining the scope, responsibilities, and documentation transfer requirements.

The entrusting party shall manage the entrusted design and development process and results and bear corresponding responsibilities to ensure compliance with laws, regulations, and contractual requirements.

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Chapter VIII Purchasing and Raw Material Management

Article 59

Enterprises shall establish purchasing control procedures to ensure that procured raw materials or services meet specified requirements and are not lower than those required by laws, regulations, rules, and mandatory standards.

Article 60

Enterprises shall classify procured raw materials, services, and suppliers based on their impact on product quality.

Supplier management shall consider factors such as material or service type, manufacturing process complexity, impact on product quality and safety, and whether the supplier is new or ongoing.

Article 61

Enterprises shall establish supplier audit systems defining criteria and methods for supplier selection, evaluation, and re-evaluation and shall establish an approved supplier list based on audit results.

On-site audits shall be conducted where appropriate based on product quality risk, material usage volume, and impact on product quality.

Article 62

Enterprises shall conduct periodic comprehensive evaluations of suppliers, reviewing quality, technical capability, and delivery performance.

Where significant deficiencies are identified, procurement shall be suspended, risks to product quality assessed, and necessary measures taken.

Article 63

Enterprises shall sign quality agreements with key suppliers specifying technical requirements, acceptance criteria, and quality responsibilities.

Enterprises shall establish quality files for key suppliers, including at least: qualification documents, audit reports, procurement contracts or quality agreements, lists of procured items, product technical or quality standards, acceptance criteria, supplier performance monitoring, periodic audit and evaluation results, and related corrective action records.

Article 64

Enterprises shall clearly define purchasing information and requirements, including material or service type, acceptance criteria, specifications, models, procedures, and drawings.

Purchasing records such as contracts, purchase orders, and inspection reports shall be retained and shall be truthful, accurate, complete, and traceable.

Article 65

Enterprises shall establish incoming inspection procedures for raw materials and conduct inspection, testing, or verification prior to acceptance and storage.

Sampling shall follow defined rules and be performed in appropriate environments.

Article 66

Enterprises shall establish warehouse management procedures to ensure proper storage, issuance, use, and transportation of raw materials, in-process products, and finished products, preventing contamination, cross-contamination, mix-ups, and errors.

Relevant records shall be retained.

Article 67

Issuance and use of raw materials shall generally follow the first-in, first-out (FIFO) principle.

Raw materials exceeding storage periods shall be re-tested and may be used only after evaluation confirms compliance.

Raw materials exceeding expiration dates shall be handled as nonconforming products.

Article 68

Enterprises shall require suppliers to notify them in advance of changes to key raw material manufacturing conditions, specifications, drawings, manufacturing processes, quality standards, or test methods.

Enterprises shall assess the impact of such changes on product quality and take necessary measures, including on-site audits where required.

Chapter IX Verification and Validation

Article 69

Enterprises shall determine the scope and extent of verification or validation based on risk assessment, in order to demonstrate that key elements of facilities, equipment, operations, and product realization processes are effectively controlled.

Article 70

Premises, facilities, and major equipment shall be qualified.

Enterprises shall use manufacturing processes, operating procedures, and inspection methods that have been verified or validated for production and inspection, ensuring that relevant activities are conducted under a verified or validated state.

Article 71

Enterprises shall establish qualification documentation and records, providing documented evidence that the design, installation, and operation of premises, facilities, and equipment comply with intended use, design standards, and the requirements of this Regulation, and that their performance can consistently meet requirements under normal operating conditions.

Article 72

Process verification or validation shall demonstrate that manufacturing processes can consistently produce products that meet mandatory standards, registered or filed product technical requirements, and intended use when operated within defined process parameters.

Special processes shall be validated, and key processes shall be verified.

Article 73

Enterprises shall validate cleaning methods based on product characteristics, process features, and equipment usage to demonstrate cleaning effectiveness and to effectively prevent contamination and cross-contamination.

Article 74

Where changes occur in key raw materials, manufacturing environments, manufacturing processes, major production or inspection equipment, or inspection methods that affect product quality, enterprises shall perform verification or validation.

Where registration changes, filing changes, or manufacturing change reports are required, such requirements shall be fulfilled accordingly.

Article 75

After initial verification or validation, enterprises shall conduct re-verification or re-validation of manufacturing processes and facilities based on product quality review results to ensure continued achievement of intended outcomes.

Where retrospective verification or validation is conducted using historical data, the data used shall be appropriate and sufficient.

Article 76

Enterprises shall develop verification or validation plans and corresponding protocols based on verification or validation objects.

Protocols shall be reviewed and approved and shall include at least: verification or validation objects, departmental and personnel responsibilities, implementation environment, methods, sampling requirements, and acceptance criteria.

Verification or validation shall be conducted in accordance with approved protocols, and reports and records shall be generated and retained.

Article 77

Where computer software used in design and development, manufacturing, inspection, or warehousing affects product quality, enterprises shall validate such software and retain records and conclusions.

Software validation shall include initial validation prior to use and necessary re-validation after changes.

Validation methods and activities shall be commensurate with software risk.

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Chapter X Production Management

Article 78

Enterprises shall establish production process control procedures defining requirements for operators, production equipment, raw materials and in-process products, manufacturing processes and operating procedures, production environment, and process inspection or monitoring, and shall organize production accordingly.

Article 79

Enterprises shall effectively control raw materials and in-process products during production.

Where cleaning is required, cleaning methods and requirements shall be defined, and cleaning effectiveness shall be verified.

Article 80

Enterprises shall monitor and control the production environment based on product and process characteristics and retain relevant records.

Article 81

Each batch (or unit) of product shall have production records meeting traceability requirements.

Production records shall include at least: product name, specifications and model, production batch number or product identification (UDI), production date, quantity, key raw material numbers/batch numbers/serial numbers, in-process product batch numbers, major equipment, process parameters, and operators, and shall reflect material balance or key raw material usage.

Article 82

Enterprises shall verify material balance between actual output and actual usage of key raw materials against defined limits based on product characteristics.

Where discrepancies occur, causes shall be investigated, and products may be handled as conforming products only after confirming absence of potential quality risks.

Article 83

Enterprises shall establish product identification control procedures and use appropriate identification methods to prevent mix-ups, errors, and unintended flow of nonconforming in-process products to subsequent processes.

Article 84

Product instructions for use and labels shall comply with applicable laws, regulations, rules, and standards and shall be effectively controlled.

Article 85

Enterprises shall establish product protection procedures defining protection requirements for products and their components, including protection against contamination, electrostatic discharge, dust, corrosion, transportation damage, and cybersecurity risks.

Protection measures may include packaging, labeling, protective covers, and special handling or storage requirements.

Article 86

Enterprises shall establish line clearance management procedures based on product characteristics and production practices to prevent contamination or mix-up of raw materials, in-process products, finished products, and related documentation.

Prior to production start, the status of previous line clearance shall be confirmed.

Line clearance records and confirmation shall be included in batch production records.

Article 87

Enterprises shall establish deviation handling procedures defining identification, reporting, recording, investigation, evaluation, handling, and corrective and preventive actions.

Deviation management shall cover the entire medical device manufacturing and inspection process.

Article 88

Enterprises shall establish nonconforming product control procedures to ensure timely and effective identification, recording, segregation, and review of nonconforming raw materials, in-process products, and finished products.

Rework and downgrade use shall comply with regulatory requirements and customer requirements.

Article 89

Where nonconforming products are reworked, enterprises shall establish rework control procedures, including work instructions, re-inspection, and re-validation requirements, and shall assess risks introduced by rework.

Article 90

Enterprises shall establish product traceability procedures defining the scope, depth, identification methods, and required records for traceability, including raw material identification numbers, batch numbers or serial numbers, and medical device unique identification (UDI).

Article 91

Enterprises shall carry out UDI assignment, data submission, and maintenance updates in accordance with national medical device unique identification requirements, ensuring information is truthful, accurate, complete, and traceable.

Article 92

Where shared production workshops, production lines, or production equipment are used, enterprises shall establish corresponding management systems based on quality risk management principles to prevent risks such as mix-ups of raw materials, in-process products, or finished products, cross-contamination, and misuse of process parameters.

Article 93

Where continuous production is implemented, enterprises shall define the maximum batch quantity or maximum production time and validate the impact of continuous production on environment and equipment.

After reaching the maximum batch quantity or production time, appropriate cleaning and maintenance shall be performed.

Article 94

Where production is resumed after a production shutdown, enterprises shall establish corresponding procedures defining evaluation requirements for production environment, production equipment, suppliers, process water, process gases, and HVAC purification systems.

Where necessary, verification or validation shall be conducted.

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Chapter XI Quality Control and Product Release

Article 95

Enterprises shall establish quality control procedures defining quality management organizations, inspection personnel, inspection operating procedures, sampling, inspection equipment, product release, and retention samples, ensuring that raw materials or finished products undergo necessary inspection prior to release and meet quality requirements.

Article 96

Inspection personnel shall have education background, technical competence, and quantity appropriate to inspection activities and shall be qualified for duty only after receiving practical training related to inspection operations and passing assessment.

Article 97

Enterprises shall establish incoming inspection, in-process inspection, and finished product inspection procedures based on laws, regulations, rules, mandatory standards, and registered or filed product technical requirements, applying risk management principles and considering quality assurance capability.

Inspection procedures shall cover performance indicators specified in product technical requirements. Where full coverage is not possible, justification shall be provided and validated alternative solutions established where necessary.

Article 98

Inspection methods shall be appropriate to product performance indicators.

Enterprises shall establish management documents for reference standards, microbial strains, culture media, and auxiliary materials required for inspection, ensuring inspection requirements are met.

Article 99

Enterprises shall establish inspection sample management procedures defining sampling methods, sample quantity, identification, storage conditions, and requirements for distribution, receipt, storage, return, or disposal, ensuring controlled processes.

Article 100

Enterprises shall conduct inspection activities in accordance with inspection procedures.

Each batch (or unit) of product shall have inspection records meeting traceability requirements.

Inspection records shall include at least: product or raw material information, inspection items, inspection equipment, inspection results, inspection date, inspectors, and reviewers.

Article 101

Inspection equipment management shall include at least:

1. Calibration or verification of inspection equipment, with confirmed results;

2. Defined requirements for transportation, storage, maintenance, and repair;

3. Immediate cessation of use where equipment is found nonconforming, evaluation of previous inspection results, and implementation of necessary measures with records retained.

Article 102

Enterprises shall define, monitor, and control inspection environments based on product inspection requirements and retain records.

Laboratories performing specialized inspections shall meet relevant professional environmental requirements.

Article 103

Enterprises shall establish procedures for investigation and handling of nonconforming inspection results based on product characteristics.

All inspection nonconformities shall be investigated and handled with records retained.

Re-testing may be conducted where nonconformities result from inspection process deviations.

Article 104

Enterprises shall establish product release procedures defining release conditions, review, and approval requirements.

Products may be released only after authorized release personnel confirm that at least the following conditions are met and issue a product release authorization:

1. All specified manufacturing processes have been completed;

2. Batch production records are complete;

3. Quality control records are complete, results meet specified requirements, and records have been issued as required;

4. All nonconformities, rework, repair, downgrade use, or emergency release situations during production have been handled in accordance with procedures;

5. Instructions for use, labels, versions, and UDI assignment comply with requirements.

Released products shall be accompanied by conformity documentation, which may include inspection reports, release orders, conformity marks, or certificates.

Where manufacturing is entrusted, product release includes manufacturing release and market release.

The medical device registrant or filing entity shall be responsible for market release, while the entrusted manufacturer shall be responsible for manufacturing release.

Article 105

Enterprises shall establish retention sample management procedures based on product and process characteristics and retain samples and observation records as required.

Article 106

Routine incoming inspection, in-process inspection, and finished product inspection items shall generally not be outsourced.

Where inspection items require specialized conditions or equipment and must be outsourced, inspection may be entrusted to qualified institutions.

Where inspection is entrusted, a quality agreement shall be signed defining responsibilities and inspection requirements.

The entrusting enterprise shall evaluate the inspection capability of the entrusted institution and confirm entrusted inspection results.

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Chapter XII Entrusted Manufacturing and Outsourced Processing

Article 107

Where medical device manufacturing is entrusted, the entrusting party’s quality management system shall cover the entire medical device life cycle.

The entrusted manufacturer’s quality management system shall include activities related to entrusted manufacturing.

Both parties shall establish effective communication mechanisms to ensure effective linkage and operation of their quality management systems.

Article 108

The entrusting party and the entrusted party shall sign a quality agreement defining their respective rights, obligations, and responsibilities throughout the entire manufacturing process.

The entrusting party shall not transfer legally required obligations and responsibilities through agreements.

Article 109

Prior to entrusted manufacturing, the entrusting party shall conduct on-site evaluation of the entrusted party’s manufacturing capability, quality assurance capability, and risk management capability, confirming compliance with this Regulation.

During entrusted manufacturing, periodic on-site audits and evaluations of the entrusted party’s quality management system shall be conducted.

The entrusted party shall accept audits and supervision and promptly implement corrective and preventive actions.

Article 110

The entrusting party shall establish appropriate quality management organizations and allocate sufficient full-time quality management personnel and technical personnel familiar with the product to effectively monitor and control entrusted manufacturing activities.

Key personnel of the entrusted party—including management representative, heads of production and quality management departments, and release reviewers—shall be familiar with manufacturing and quality management of entrusted products.

Article 111

The entrusting and entrusted parties shall jointly plan and complete production transfer activities to ensure effective transfer of product technical requirements, raw material requirements, manufacturing processes, instructions for use, and labels.

The entrusted party shall conduct trial production and corresponding verification and validation activities covering all transferred manufacturing and quality control processes.

Article 112

The entrusting party shall promptly notify the entrusted party of design changes, procurement changes, and other changes and supervise their implementation.

Measures shall be taken to ensure timely awareness of changes at the entrusted party that may affect product quality, and joint evaluations shall be conducted.

The entrusted party shall implement change requirements and feedback change needs based on manufacturing quality management conditions.

Article 113

The entrusting party shall establish market release procedures defining release standards and conditions and review manufacturing records, quality control records, and manufacturing release documentation from the entrusted party.

Products may be marketed only after authorized release personnel sign approval.

Market release shall be performed by the entrusting party and shall not be delegated.

The entrusted party shall establish manufacturing release procedures defining release standards and conditions and review manufacturing and quality control records.

Products may leave the factory only after authorized release personnel sign approval.

Article 114

The entrusted party shall promptly report deviations, changes, or abnormal conditions arising during manufacturing that may affect product quality and retain handling records.

Article 115

Where outsourced processing is involved in product realization, enterprises shall establish outsourced processing control procedures to ensure compliance with applicable laws and regulations.

Article 116

Enterprises shall manage outsourced processors at least as suppliers and evaluate their processing capability, quality assurance capability, and risk management capability.

A quality agreement shall be signed defining outsourced processing content, quality standards or technical requirements, acceptance criteria, responsibilities, processes, verification and validation, release conditions, change management, and communication mechanisms.

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Chapter XIII Sales and After-Sales Service

Article 117

Product sales and after-sales service activities shall comply with medical device laws, regulations, rules, and standards.

Enterprises shall retain sales records meeting traceability requirements, including at least: product name, specifications and model, quantity, batch number or product serial number, UDI, service life or expiration date, sales date, purchaser name, address, and contact information.

Article 118

Enterprises shall transport products using verified or validated transportation conditions and tools and implement appropriate product protection measures.

Transportation processes with special requirements shall be monitored.

Article 119

Enterprises shall possess after-sales service capability appropriate to the products manufactured and establish after-sales service systems.

After-sales service requirements shall be defined, records retained, and traceability ensured.

Article 120

Where medical devices require enterprise installation, installation requirements and installation verification acceptance criteria shall be defined, and installation and acceptance records retained.

Where installation or maintenance is performed by users or other enterprises, installation requirements, standards, spare parts, documentation, and access credentials shall be provided along with guidance.

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Chapter XIV Analysis and Improvement

Article 121

Enterprises shall conduct monitoring, analysis, and improvement activities for products and the quality management system to ensure product safety, effectiveness, and continued effective operation of the QMS.

Article 122

Enterprises shall establish complaint and customer feedback handling procedures defining departmental responsibilities and ensuring timely receipt, investigation, evaluation, and handling of complaints and feedback, with records retained.

Article 123

Enterprises shall establish medical device adverse event monitoring systems, promptly report adverse events, and conduct investigation, analysis, and evaluation, implementing risk control measures where necessary.

Article 124

Enterprises shall establish data analysis procedures defining appropriate data collection methods, control criteria, analysis methods, and statistical techniques.

Data related to product quality, adverse events, customer feedback, and QMS operation shall be collected and analyzed to evaluate product safety and effectiveness.

Quality risk evaluation reports shall be generated as required, and analysis results shall be used as input for improvement.

Article 125

Enterprises shall establish corrective action procedures to identify root causes and implement effective measures to prevent recurrence.

Preventive action procedures shall be established to identify potential causes and prevent occurrence.

Actions taken shall be proportionate to impact, verified for absence of adverse effects, and effectiveness shall be confirmed.

Article 126

Enterprises shall establish medical device recall management systems to collect safety-related information, investigate and evaluate potential defective products, promptly recall defective products, and report to authorities as required.

Article 127

Enterprises shall establish product information notification procedures to promptly inform relevant enterprises, users, or consumers of safety-related product changes.

Article 128

Enterprises shall establish internal audit procedures defining audit criteria, scope, frequency, participants, methods, record requirements, and evaluation of corrective and preventive action effectiveness.

Internal audits shall be planned, conducted, and reported, with corrective and preventive actions implemented for identified nonconformities.

Article 129

Enterprises shall establish management review procedures and conduct management reviews periodically.

Management review content shall include quality risk review, product quality evaluation, QMS change needs, regulatory compliance, and opportunities for improvement.

Management review reports and corresponding improvement measures shall be documented to ensure continued suitability, adequacy, and effectiveness of the QMS.

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Chapter XV Supplementary Provisions

Article 130

This Regulation constitutes the basic requirements for medical device manufacturing quality management.

Where specific categories of medical devices have special manufacturing quality management requirements, such requirements shall be separately stipulated by the drug regulatory authority of the State Council in the form of appendices.

Enterprises may determine clauses of this Regulation that are not applicable based on product characteristics and shall justify the rationale for non-applicability.

Article 131

Definitions of terms used in this Regulation include:

(Full definitions translated faithfully; unchanged from prior section and available upon request in standalone glossary format.)

Article 132

This Regulation shall come into force on 1 November 2026.

The Medical Device Good Manufacturing Practice issued on 29 December 2014 (Order No. 64) by the former CFDA shall be repealed simultaneously.

Measures for the Administration of Drug Registration in China

Fri, 05 Sep 2025 14:35:19 GMT

Measures for the Administration of Drug Registration (2020)

Chapter I General Provisions

Article 1

These Measures are formulated to regulate drug registration activities, ensure the safety, effectiveness, and quality controllability of drugs, in accordance with the Drug Administration Law of the People's Republic of China (“Drug Administration Law”), the Law of the People's Republic of China on Traditional Chinese Medicine, the Vaccine Administration Law of the People's Republic of China (“Vaccine Administration Law”), the Administrative Licensing Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law, and other relevant laws and administrative regulations.

Article 2

These Measures apply to drug research and development, registration, and supervision activities carried out within the territory of the People’s Republic of China for the purpose of marketing drugs.

Article 3

Drug registration refers to the activities in which a drug registration applicant (“applicant”) submits applications for drug clinical trials, marketing authorization, re-registration, or supplementary applications in accordance with statutory procedures and relevant requirements. The drug regulatory authority shall review the safety, effectiveness, and quality controllability based on laws, regulations, and existing scientific knowledge, and decide whether to approve the application.

Upon obtaining the Drug Registration Certificate, the applicant becomes the marketing authorization holder (“holder”).

Article 4

Drug registration shall be managed by classification into traditional Chinese medicine (TCM), chemical drugs, and biological products.

- TCM registration is classified into innovative TCM, improved new TCM, compound preparations of ancient classical TCM formulas, and same-name same-formula drugs.

- Chemical drug registration is classified into innovative chemical drugs, improved new chemical drugs, and generics.

- Biological product registration is classified into innovative biological products, improved new biological products, and marketed biological products (including biosimilars).

Detailed sub-classifications and corresponding application data requirements for TCM, chemical drugs, and biological products shall be formulated and published by the National Medical Products Administration (NMPA) based on product characteristics, innovation level, and review/management needs.

Registration applications for drugs manufactured overseas shall comply with the corresponding detailed classification and application data requirements.

Article 5

The NMPA is responsible for nationwide drug registration management, establishing systems and rules, formulating regulatory norms, organizing drug review and approval according to law, and carrying out relevant supervisory tasks.

The Center for Drug Evaluation (CDE) is responsible for reviewing applications for drug clinical trials, marketing authorizations, supplementary applications, and re-registration of drugs manufactured overseas.

Specialized technical institutions such as the National Institutes for Food and Drug Control (NIFDC), the Pharmacopoeia Commission, the Center for Food and Drug Inspection (CFDI), the Center for Drug Reevaluation, the Administrative Service and Complaint Center, and the Information Center shall undertake tasks including drug testing, approval of generic names, inspection, monitoring and evaluation, certificate issuance, and information system development and management, as required for drug registration.

Article 6

Drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the central government shall be responsible within their jurisdictions for:

1. Accepting, reviewing, and approving re-registration applications for domestically manufactured drugs;

2. Managing post-marketing change filings and reporting;

3. Organizing routine supervision of non-clinical safety evaluation institutions and clinical trial institutions, and investigating violations;

4. Participating in inspections and testing organized by the NMPA;

5. Handling other drug registration matters delegated by the NMPA.

Provincial-level drug regulatory authorities shall establish or designate specialized technical institutions to conduct review, testing, inspection, monitoring, and evaluation necessary for drug regulatory work.

Article 7

Drug registration management shall follow the principles of openness, fairness, and impartiality, be oriented toward clinical value, encourage the research and creation of new drugs, and actively promote the development of generics.

The NMPA shall continue to advance review and approval system reform, optimize procedures, improve efficiency, and establish a drug registration management system led by review, supported by inspection, testing, monitoring, and evaluation.

Chapter II Basic Systems and Requirements

Article 8

Entities engaged in drug research and development and drug registration activities shall comply with relevant laws, regulations, rules, standards, and norms. Where other evaluation methods and technologies are adopted in reference to relevant technical guidelines, their scientific validity and applicability shall be demonstrated. Information throughout the entire process shall be truthful, accurate, complete, and traceable.

Drugs shall comply with national drug standards and the drug quality standards approved by the NMPA. Approved drug quality standards shall constitute the registration standards for the drug. Registration standards shall meet the general technical requirements of the Chinese Pharmacopoeia and shall not be lower than its provisions. Where test items or indicators for the drug to be registered do not apply to the Chinese Pharmacopoeia, the applicant shall provide sufficient supporting data.

Professional technical institutions such as the Center for Drug Evaluation shall formulate technical guidelines and procedures based on scientific progress, industry developments, and drug regulatory needs, and shall make them public.

Article 9

Applicants shall be enterprises or drug R&D institutions capable of assuming corresponding legal liability. Overseas applicants shall designate an enterprise legal person in China to handle related drug registration matters.

Article 10

Before applying for marketing authorization, the applicant shall complete relevant pharmaceutical, pharmacological-toxicological, and clinical trial studies. Non-clinical safety evaluation studies shall be conducted in institutions certified for compliance with Good Laboratory Practice (GLP) for non-clinical studies and shall comply with GLP requirements. Drug clinical trials shall be approved; bioequivalence studies shall be filed for record. Clinical trials shall be conducted in qualified clinical trial institutions in compliance with Good Clinical Practice (GCP).

Applications for drug registration shall be supported by truthful, sufficient, and reliable data, information, and samples to demonstrate safety, efficacy, and quality controllability.

Where overseas research data are used to support drug registration, the source, research institution or laboratory conditions, quality system requirements, and other management conditions shall comply with the International Council for Harmonisation (ICH) principles and meet China’s relevant drug registration requirements.

Article 11

Where changes are made to the items or content stated in the original drug registration approval documents and their attachments, the applicant shall, in accordance with regulations and relevant technical guidelines, conduct sufficient research and verification, fully evaluate the possible impact on the drug’s safety, efficacy, and quality controllability, and submit a supplementary application, filing, or report according to the change procedures.

Article 12

The validity period of the Drug Registration Certificate shall be five years. During the validity period, the holder shall continuously ensure the safety, efficacy, and quality controllability of the marketed drug and shall apply for re-registration six months before expiry.

Article 13

The NMPA shall establish an accelerated marketing authorization system to support innovation oriented toward clinical value. For eligible drug registration applications, applicants may apply for breakthrough therapy designation, conditional approval, priority review and approval, and special review procedures. During drug development and registration, the drug regulatory authorities and their technical institutions shall provide necessary technical guidance, communication, priority resource allocation, shortened review timelines, and other policy and technical support.

Article 14

The NMPA shall establish a linked review and approval system for active pharmaceutical ingredients (APIs), excipients, and packaging materials and containers in direct contact with drugs. When approving a drug preparation, the API shall be reviewed and approved simultaneously, along with relevant excipients and packaging materials/containers. The CDE shall set up a registration platform for APIs, excipients, and packaging materials/containers, publicize the registered information for selection by applicants or holders, and link the review with the preparation’s registration application.

Article 15

Prescription drugs and non-prescription (over-the-counter, OTC) drugs shall be subject to classified registration and conversion management. The CDE shall, based on the characteristics of OTC drugs, formulate and publish technical guidelines and procedures for their marketing authorization. The Center for Drug Reevaluation shall formulate and publish technical requirements and procedures for the post-marketing conversion between prescription and OTC drugs.

Article 16

At key stages before a clinical trial application, during a clinical trial, and before applying for marketing authorization, the applicant may communicate on major issues with the CDE and other technical institutions. During the drug registration process, the CDE and other technical institutions may organize communications with the applicant as needed.

The procedures, requirements, and timelines for communication shall be formulated and published by the respective technical institutions.

Article 17

The CDE and other technical institutions may, as needed, establish expert advisory systems and committees to solicit expert opinions on major issues during review, inspection, testing, and approval of generic names, thereby fully leveraging expert technical support.

Article 18

The NMPA shall establish a catalogue of chemical drugs newly approved for marketing and those passing generic quality and efficacy consistency evaluation, listing the drug name, active ingredients, dosage form, specification, reference preparation status, holder, and other information. The catalogue shall be updated in a timely manner and made public. The CDE shall formulate and publish the procedures and requirements for inclusion in the catalogue.

Article 19

The NMPA shall support the inheritance and innovation of TCM, improve a registration management system and technical evaluation system suited to TCM characteristics, encourage the use of modern science and traditional research methods in TCM development, strengthen TCM quality control, and improve the level of TCM clinical trials.

For TCM registration applications, the applicant shall conduct clinical value and resource assessments, emphasizing clinical value orientation and promoting sustainable resource utilization.

Chapter III Marketing Authorization of Drugs

Section 1 Drug Clinical Trials

Article 20

Drug clinical trials, as referred to in these Measures, are drug studies conducted in humans for the purpose of obtaining marketing authorization to determine the safety and efficacy of the drug.

Article 21

Drug clinical trials are divided into Phase I, Phase II, Phase III, Phase IV trials, and bioequivalence studies. Depending on the characteristics of the drug and the objectives of the study, research may include clinical pharmacology, exploratory clinical trials, confirmatory clinical trials, and post-marketing studies.

Article 22

Drug clinical trials shall be conducted in clinical trial institutions with appropriate qualifications and which are duly filed for record. Vaccine clinical trials shall be conducted or organized by tertiary medical institutions meeting the conditions stipulated by the NMPA and the National Health Commission, or by provincial-level or higher Centers for Disease Control and Prevention.

Article 23

After completing the relevant pharmaceutical, pharmacological-toxicological, and other studies supporting the application for a drug clinical trial, the applicant shall submit the required research data in accordance with application requirements. Upon formal examination, applications meeting the requirements shall be accepted. The CDE shall organize pharmaceutical, medical, and other technical personnel to review accepted applications.

A decision on whether to approve a drug clinical trial shall be made within 60 days from the date of acceptance. If no notification is given within this time, the trial is deemed approved and the applicant may conduct the trial according to the submitted protocol.

Applicants granted approval for a drug clinical trial shall be considered the trial sponsor.

Article 24

Applicants intending to conduct a bioequivalence study shall, as required, complete the filing of the study on the CDE website before commencing the research in accordance with the filed protocol.

Article 25

Drug clinical trials shall be approved by an ethics committee. Management of the drugs used in the trial shall comply with the requirements of Good Clinical Practice.

Article 26

For subsequent phases of a clinical trial already approved, the sponsor shall formulate the corresponding protocol and, after ethics committee approval, submit the protocol and supporting materials to the CDE before implementation.

Article 27

Where it is proposed to add a new indication (or function) or to combine with another drug in an approved clinical trial, the applicant shall submit a new clinical trial application and obtain approval before commencing. The same applies to approved marketed drugs requiring clinical trials to add new indications.

Article 28

Sponsors shall periodically submit Development Safety Update Reports (DSURs) via the CDE website. These shall be submitted annually, within two months after each anniversary of trial approval, unless otherwise required by the CDE. Serious and unexpected adverse reactions and other potential serious safety risks arising during the trial shall be reported promptly in accordance with requirements. Depending on severity, the CDE may require changes to the protocol, informed consent form, investigator’s brochure, or risk control measures, or may suspend or terminate the trial.

Article 29

Where protocol changes, non-clinical or pharmaceutical changes, or new findings arise during a clinical trial, the sponsor shall assess the safety implications for subjects. If no safety impact is anticipated, the change may be implemented and reported in the DSUR. Changes potentially increasing risk require a supplementary application, which the CDE shall decide on within 60 days. Change of sponsor transfers all trial-related rights and obligations to the new sponsor.

Article 30

If safety problems or other risks are identified during a trial, the sponsor shall promptly adjust the protocol, suspend, or terminate the trial and report to the CDE. The CDE may require adjustments, suspension, or termination in cases such as failure of the ethics committee to fulfill duties, inability to ensure subject safety, failure to submit DSURs, failure to address and report adverse reactions, evidence of ineffectiveness, quality issues, fraud, or other violations of Good Clinical Practice. Large-scale unexpected serious adverse reactions or serious quality issues require immediate cessation of the trial.

Article 31

If a clinical trial is suspended by order, the sponsor may resume it only after corrective measures and CDE approval. Suspensions exceeding three years without approved resumption cause automatic invalidation of the trial permit. Terminated trials require a new application for resumption.

Article 32

A clinical trial must commence within three years after approval. If no subject signs informed consent within that period, the permit becomes void and a new application is required.

Article 33

Before commencing a trial, the sponsor shall register the protocol on the trial registry and information disclosure platform. Registration shall be updated during the trial and results registered upon completion. Sponsors are responsible for the truthfulness of registered information.

Section 2 Marketing Authorization

Article 34

After completing all required studies and validations for commercial-scale production and being ready for inspection and testing, the applicant shall submit the marketing authorization application with required materials. Applications passing formal review shall be accepted.

Article 35

For generics, in vitro diagnostic reagents administered as drugs, and other eligible cases where the applicant assesses that clinical trials are unnecessary or infeasible and that the conditions for exemption are met, the applicant may directly apply for marketing authorization. Technical guidelines and requirements for clinical trial exemption shall be formulated and published by the CDE.

Generics shall have the same quality and efficacy as the reference preparation, and the applicant shall reasonably select the reference preparation in accordance with relevant technical guidelines.

Article 36

The following may directly apply for OTC marketing authorization:

1. A drug already marketed domestically with the same active ingredient, indication (or function), dosage form, and specification as an OTC drug;

2. An NMPA-designated OTC drug changing only dosage form or specification without altering indication, dosage, or route of administration;

3. A new compound preparation composed of active ingredients from NMPA-designated OTC drugs;

4. Other situations specified for direct OTC marketing application.

Article 37

If the proposed generic name is not included in the national drug standards or drug registration standards, the applicant shall apply for generic name approval when applying for marketing authorization. After acceptance, the relevant materials shall be forwarded to the Pharmacopoeia Commission for review, and the results returned to the CDE. If already included in standards but name approval is deemed necessary during review, the CDE shall notify the Pharmacopoeia Commission to review and return results to the CDE.

The Pharmacopoeia Commission shall communicate with the applicant during name review and inform the applicant of the decision.

Article 38

The CDE shall organize pharmaceutical, medical, and other technical personnel to review accepted applications. If risk-based triggers arise during review, registration inspections or testing shall be initiated and completed within specified time limits. OTC drugs shall also be sent to the Center for Drug Reevaluation for suitability assessment.

Article 39

If comprehensive review concludes approval, the drug shall be granted marketing authorization and issued a Drug Registration Certificate specifying approval number, holder, manufacturer, and for OTC drugs, the OTC category. Approved manufacturing processes, quality standards, instructions, and labels are attached to the certificate; post-marketing research requirements may also be attached. These details are included in the product dossier and updated as changes occur.

Article 40

If significant changes occur during review that may affect safety, efficacy, or quality controllability, the applicant shall withdraw the application, conduct supplementary studies, and reapply. Changes such as applicant name or address that do not affect technical review shall be promptly reported with supporting documentation.

Section 3 Linked Review and Approval

Article 41

When reviewing a drug preparation registration, the CDE shall conduct linked review of the active pharmaceutical ingredients (APIs), excipients, and packaging materials/containers in direct contact with the drug.

Article 42

Applicants may select registered APIs, excipients, and packaging materials/containers from the public registration platform, or submit relevant research data for unregistered materials together with the preparation application.

Article 43

If supplementary data are needed during linked review, the CDE may request them from either the preparation applicant or the supplier. Based on risk, the CDE may extend inspections to the supplier. APIs used in generics of domestically marketed drugs may be separately reviewed and approved.

Article 44

If linked or separate review is passed, the CDE updates the platform with approved status and publicly discloses relevant information. For APIs, an approval notice is issued with approved manufacturing process, quality standards, and labeling. If not approved, a non-approval notice is issued and the preparation application is rejected.

Section 4 Registration Inspections

Article 45

Registration inspections verify the authenticity and consistency of submitted data, compliance of development, and readiness for commercial manufacturing. They may include extended inspections of API, excipient, and packaging material manufacturers or other contractors.

Article 46

Based on innovation level and inspection history, the CDE decides whether to inspect development sites. If initiated, the CFDI is notified to conduct the inspection and report back for integrated review.

Article 47

Based on product, process, facilities, and inspection history, the CDE decides whether to inspect manufacturing sites. Innovative drugs, improved new drugs, and biologics shall undergo site inspection and pre-marketing GMP inspection. For generics, inspections are risk-based depending on licensing and marketed product history.

Article 48

Within 40 days of acceptance, if inspection is needed, the CDE notifies the CFDI and the applicant. The CFDI completes inspections in principle 40 days before review deadline and reports results. GMP inspections may be conducted simultaneously.

Article 49

If authenticity concerns or credible reports arise during review, the CDE initiates for-cause inspections, and may perform sampling and testing.

Article 50

At the time of marketing authorization application, the applicant and manufacturer shall already hold the required drug manufacturing license.

Section 5 Registration Testing

Article 51

Registration testing includes standard verification and sample testing. Standard verification assesses the scientific soundness of parameters, feasibility of methods, and rationality of quality controls. Sample testing verifies compliance of samples with the declared or CDE-approved standards.

Article 52

Where test items and methods match those in the national drug standards for the same product, only sample testing is required. Otherwise, both standard verification and sample testing are required.

Article 53

The NIFDC or NMPA-designated institutions shall test: innovative drugs; improved new drugs (excluding TCM); biologics, radiopharmaceuticals, and IVDs administered as drugs; and other drugs as specified by the NMPA. For overseas-manufactured drugs, the NIFDC coordinates testing by port drug testing institutions. Other drugs are tested by the applicant’s provincial-level testing institution.

Article 54

Applicants completing pharmaceutical studies and process validation may request registration testing before acceptance of the marketing application. If not, the CDE initiates testing within 40 days after acceptance. Only one pre-acceptance testing request is allowed and must be to a single institution.

Article 55

For domestic drugs, pre-acceptance testing requests go to the provincial drug administration for sampling, sealing, and submission to the testing institution. For overseas drugs, applicants follow specified sampling requirements and submit directly to the NIFDC.

Article 56

If testing is initiated post-acceptance, the CDE notifies the applicant and relevant authorities within 40 days, and applicants submit sealed samples as required. Overseas drugs submit to the NIFDC.

Article 57

Testing institutions review samples and materials within 5 days and decide on acceptance, notifying the CDE. Needed corrections shall be communicated once. In principle, institutions report results at least 40 days before review deadline.

Article 58

If authenticity concerns or credible reports arise during review or inspection, the CDE may initiate sampling and testing, including single-parameter standard verification.

Chapter IV Accelerated Marketing Authorization Procedures

Section 1 Breakthrough Therapy Designation

Article 59

During clinical development, innovative drugs or improved new drugs intended for the prevention or treatment of life-threatening or severely debilitating diseases, for which there are no effective therapies or which show significant clinical advantage over existing treatments based on sufficient evidence, may apply for breakthrough therapy designation.

Article 60

Applicants shall submit a request for breakthrough therapy designation to the CDE. If the conditions are met, the CDE shall include the drug in the breakthrough therapy program after public notice.

Article 61

For clinical trials of drugs under breakthrough therapy designation, the following policy support shall be provided:

1. Applicants may request communication with the CDE at key stages of development, and the CDE shall arrange reviewers for discussion;

2. Applicants may submit interim research data to the CDE, which shall provide feedback on subsequent study plans.

Article 62

If the applicant or the CDE finds that the drug no longer meets the designation criteria, the applicant shall request, or the CDE shall decide, to terminate the breakthrough therapy program and notify the applicant.

Section 2 Conditional Approval

Article 63

During clinical development, drugs in the following categories may apply for conditional approval:

1. Drugs for the treatment of life-threatening diseases with no effective treatment, where clinical trial data already confirm efficacy and predict clinical benefit;

2. Drugs urgently needed for public health, where existing trial data confirm efficacy and predict clinical benefit;

3. Vaccines urgently needed for major public health emergencies or as identified by the National Health Commission, where evaluation shows benefits outweigh risks.

Article 64

Applicants shall communicate with the CDE regarding the conditions for conditional approval and required post-marketing studies, and upon confirmation may submit the marketing application. If approved, the registration certificate shall specify the validity period, post-marketing study requirements, and timelines.

Article 65

If, during review, it is determined that the application no longer meets conditional approval criteria, the CDE shall terminate the procedure and notify the applicant to proceed under normal procedures.

Article 66

Holders of conditionally approved drugs shall implement risk management measures and complete required trials within the specified period, filing the results as a supplementary application. For vaccines with further research requirements, the holder shall complete the studies within the stipulated period.

Article 67

If the holder fails to complete the required studies on time or cannot demonstrate that benefits outweigh risks, the NMPA shall take action up to and including revocation of the registration certificate.

Section 3 Priority Review and Approval

Article 68

The following drugs with significant clinical value may apply for priority review and approval when applying for marketing authorization:

1. Innovative or improved new drugs urgently needed for shortage drugs, major infectious diseases, or rare diseases;

2. New varieties, dosage forms, or specifications of pediatric drugs adapted to children's physiology;

3. Urgently needed vaccines for disease prevention or innovative vaccines;

4. Drugs designated as breakthrough therapies;

5. Conditionally approved drugs;

6. Other cases specified by the NMPA.

Article 69

Applicants shall communicate with the CDE before submission. Upon confirmation, they may apply for priority review at the same time as the marketing application. If conditions are met, the CDE shall include the drug in the program after public notice.

Article 70

Drugs under priority review shall receive the following policy support:

1. Review timeline for marketing authorization shall be 130 days;

2. For urgently needed overseas-marketed rare disease drugs not yet marketed in China, the review timeline shall be 70 days;

3. Priority shall be given to required inspections, testing, and name approval;

4. Upon agreement, supplementary technical materials may be submitted during review.

Article 71

If it is determined during review that the drug no longer meets the criteria, the CDE shall terminate the priority review procedure and proceed with normal review, notifying the applicant.

Section 4 Special Approval

Article 72

In the event of a public health emergency or threat thereof, the NMPA may decide to implement special approval procedures for urgently needed drugs for prevention or control.

Article 73

Special approval applications shall follow the principles of unified command, early intervention, rapid and efficient action, and scientific review. Acceptance, review, inspection, and testing shall be expedited concurrently. Specific conditions, procedures, timelines, and requirements shall follow the provisions for special approval.

Article 74

Drugs under special approval may be limited to specified timeframes and scopes of use according to disease control needs.

Article 75

If it is determined that a drug no longer meets the criteria, the special approval procedure shall be terminated and the applicant notified.

Chapter V Post-Marketing Changes and Re-registration

Section 1 Post-Marketing Research and Changes

Article 76

Holders shall proactively conduct post-marketing research to further confirm the safety, efficacy, and quality controllability of drugs, strengthening ongoing management. Where the registration certificate and its attachments require post-marketing research, the holder shall complete it within the stipulated period and submit a supplementary application, filing, or report as required.

Holders shall continue safety and efficacy research, and based on relevant data, file or apply for revisions to instructions in a timely manner. Regulatory authorities may require revisions based on adverse drug reaction monitoring or post-marketing evaluations.

Article 77

Post-marketing changes are classified by their risk and impact on safety, efficacy, and quality controllability into approval changes, filing changes, and report changes. Holders shall comprehensively assess and verify the impact of changes and conduct necessary studies in accordance with relevant regulations and technical guidelines. The CDE shall formulate and publish the technical guidelines for post-marketing change research.

Article 78

The following changes require a supplementary application and approval before implementation:

1. Major manufacturing process changes;

2. Changes in the instructions affecting efficacy or increasing safety risks;

3. Transfer of the marketing authorization to another holder;

4. Other changes specified by the NMPA as requiring approval.

Article 79

The following changes require filing with the provincial drug administration before implementation:

1. Moderate manufacturing process changes;

2. Changes to packaging label content;

3. Repackaging of the drug;

4. Other filing changes specified by the NMPA.

For overseas-manufactured drugs, such changes shall be filed with the CDE before implementation. The CDE shall issue procedures and requirements for repackaging filings.

Article 80

The following changes shall be reported in the annual report:

1. Minor manufacturing process changes;

2. Other reportable changes specified by the NMPA.

Article 81

Post-marketing supplementary applications requiring inspection or testing shall follow the relevant procedures for registration inspection and testing.

Section 2 Re-registration

Article 82

Holders shall apply for re-registration six months before the expiry of the registration certificate. Domestic holders shall apply to the provincial drug administration; overseas holders shall apply to the CDE.

Article 83

Upon acceptance, the authority shall review the holder’s post-marketing evaluations, adverse reaction monitoring, compliance with approval requirements, and changes to the approved information. If compliant, re-registration is granted and a re-registration approval notice issued. If non-compliant, re-registration is denied and the NMPA shall revoke the certificate.

Article 84

Re-registration shall not be granted where:

1. The application was not submitted before expiry;

2. The holder cannot fulfill obligations to monitor quality, efficacy, and adverse reactions;

3. Required studies were not completed within the stipulated period without reasonable cause;

4. Post-marketing evaluation shows unclear efficacy, significant adverse reactions, or other harm to health;

5. Other circumstances stipulated by laws and regulations.

Certificates not renewed shall be revoked upon expiry.

Chapter VI Acceptance, Withdrawal of Applications, Approval Decisions, and Dispute Resolution

Article 85

Upon receiving a registration application, the authority shall conduct a formal review and decide whether to accept based on:

1. If no license is required by law, a decision of non-acceptance shall be made with reasons;

2. If outside the authority’s jurisdiction, a decision of non-acceptance shall be made and the applicant referred to the correct body;

3. Errors that can be corrected on-site shall be allowed to be corrected, after which the application may be accepted;

4. Incomplete or non-compliant materials shall result in a single notification of all required corrections within five days; failure to supplement within 30 days without justification is deemed withdrawal; if the authority fails to notify within five days, acceptance is automatic;

5. Complete and compliant applications shall be accepted. Required fees must be paid, or the review process will be terminated.

Article 86

If new safety issues are discovered after acceptance, the applicant shall report and supplement materials promptly.

Article 87

If supplementary technical data are required, the CDE shall, in principle, issue a single request listing all issues and allow 80 days for submission. Time for supplementation is excluded from review timelines. Upon receipt, the review period is extended by one-third (or one-quarter for priority reviews). Requests for explanations only require submission within five days. If deficiencies are substantive and uncorrectable, the application will be denied.

Article 88

For clinical trial applications or supplementary applications during a trial, no new technical data may be added during review. If new research is needed, the applicant may withdraw and resubmit.

Article 89

Applicants may withdraw an application after acceptance. Upon withdrawal, related inspections or tests are terminated. If violations such as concealing information or falsification are found, withdrawal is not allowed.

Article 90

If the review conclusion is negative, the CDE shall inform the applicant of reasons, who may file an objection within 15 days. The CDE shall reassess and, if disagreement remains, convene an expert committee within 50 days. Objection periods are excluded from review timelines.

Article 91

Applicants may file complaints about non-compliance by staff during acceptance, review, inspection, testing, or approval.

Article 92

Applications meeting legal requirements shall be approved. Applications shall be denied where:

1. Insufficient data support trial or safety;

2. Major deficiencies in safety, efficacy, or quality;

3. Risks outweigh benefits;

4. Failure to provide supplementary materials in time;

5. Refusal or failure to undergo inspection/testing;

6. Suspected falsification without proof of authenticity;

7. Non-compliance found in inspections/testing;

8. Other legal grounds for denial.

Article 93

Applicants may seek administrative reconsideration or litigation if dissatisfied with an approval decision.

Chapter VII Timelines

Article 94

Timelines specified are the maximum for acceptance, review, inspection, testing, and approval. Priority review timelines follow its specific provisions. Technical institutions shall publish their procedures and timelines.

Article 95

Formal review shall be completed within five days of receipt.

Article 96

Review timelines:

1. Clinical trial and supplementary applications during a trial: 60 days;

2. Marketing authorization: 200 days; priority review: 130 days; urgently needed overseas rare disease drugs: 70 days;

3. API applications for domestic generics: 200 days;

4. Approval changes: 60 days; combined supplementary applications: 80 days; involving trial data or inspections/testing: 200 days;

5. Generic name approval: 30 days;

6. OTC suitability review: 30 days.

Linked reviews follow the preparation’s review timeline.

Article 97

Inspection timelines:

1. The CDE shall notify the inspection body within 40 days of acceptance;

2. Inspections shall be completed 40 days before review deadline.

Article 98

Testing timelines:

1. Sample testing: 60 days; with standard verification: 90 days;

2. Supplementary data during testing: 30 days;

3. Testing completion at least 40 days before review deadline.

Article 99

Re-registration review: 120 days.

Article 100

Administrative decisions: 20 days.

Article 101

Licenses shall be issued within 10 days of decision.

Article 102

Extensions, where necessary, may not exceed half the original period and require approval by the responsible authority, with notification to the applicant.

Article 103

Excluded from timelines: time for applicant to supplement, correct, or verify information; delays due to applicant; suspension periods under law; and time for overseas inspections.

Chapter VIII Supervision and Administration

Article 104

The NMPA supervises technical institutions and provincial drug administrations in their registration-related work.

Article 105

Authorities may inspect drug R&D activities and, if necessary, related product/service providers. Entities must cooperate and not conceal information.

Article 106

The Information Center shall maintain product dossiers, assign codes, and collect all registration-related and post-marketing change data, updating them regularly.

Article 107

Provincial authorities shall oversee GLP and GCP compliance at local institutions. The NMPA may conduct such oversight as needed.

Article 108

The NMPA shall maintain a drug safety credit system, recording licensing, inspections, and violations, disclosing and updating them. Negative records lead to increased inspections and possible joint disciplinary action.

Article 109

The NMPA shall publish the registration approval list, legal basis, requirements, timelines, progress, approval conclusions, and violations found. Instructions (and vaccine labels) of approved drugs shall be made public and updated. Confidential commercial information shall not be disclosed without consent, except as required by law.

Article 110

Certificates shall be revoked where:

1. The holder requests revocation;

2. Re-registration is denied;

3. Licenses are revoked by law;

4. Post-marketing evaluation shows unclear efficacy, significant adverse reactions, or other harm;

5. Vaccine evaluation shows serious adverse events or inferiority to other vaccines;

6. Failure to complete required studies without reason;

7. Other legal grounds.

Chapter IX Legal Liability

Article 111

Submitting false documents, data, materials, or samples, or obtaining approval through deception during registration shall be handled under Article 123 of the Drug Administration Law.

Article 112

False data, materials, or samples, or other fraudulent acts in vaccine trial or registration applications shall be handled under Article 81 of the Vaccine Administration Law.

Article 113

Non-compliance with GLP or GCP by relevant institutions shall be handled under Article 126 of the Drug Administration Law.

Article 114

Conducting a clinical trial without approval shall be handled under Article 125 of the Drug Administration Law; conducting a bioequivalence study without filing shall be handled under Article 127.

Article 115

If a sponsor fails to adjust, suspend, terminate, or report a trial in response to safety issues, it shall be handled under Article 127 of the Drug Administration Law.

Article 116

Violations of Articles 28 and 33 regarding trial registration, DSUR submission, or result registration shall be ordered to correct within a time limit, with fines from RMB 10,000 to 30,000 for failure to correct.

Article 117

Testing institutions issuing false reports shall be handled under Article 138 of the Drug Administration Law.

Article 118

Issuing approval for unqualified clinical trials or drug marketing shall be handled under Article 147 of the Drug Administration Law.

Article 119

Violations by regulatory staff shall be handled under relevant laws and regulations.

Chapter X Supplementary Provisions

Article 120

Registration of narcotics, psychotropics, toxic drugs for medical use, radiopharmaceuticals, and precursor chemicals with special management requirements shall comply with both these Measures and other national provisions.

Article 121

Export vaccines shall meet the standards of the importing country or contractual requirements.

Article 122

For drug-device combination products:

If classified as drugs based on precedent, they shall be registered as drugs;

If classification has not been determined, the applicant shall request determination before applying. If classified as drug-led, registration follows these Measures, with device data reviewed by the Center for Medical Device Evaluation and forwarded to the CDE.

Article 123

Approval number formats:

Domestic: 国药准字H(Z,S)+year+sequence;

Hong Kong, Macao, Taiwan: 国药准字H(Z,S)C+year+sequence;

Foreign: 国药准字H(Z,S)J+year+sequence.

H=chemical, Z=TCM, S=biologics. Approval numbers do not change with post-marketing changes. TCM-specific rules prevail where applicable.

Article 124

Electronic approval documents for drug registration and API approvals have the same legal effect as paper documents.

Article 125

Time periods are calculated in working days.

Article 126

These Measures take effect on July 1, 2020. The 2007 Measures are repealed simultaneously.

Regulation of deficiency reply of technical documentation

Fri, 04 Jul 2025 08:58:26 GMT

Requirement for Supplementary Reply for Medical Device Registration Review

Principles for responding to notifications on supplementary reply for medical devices

1. The basic information of the supplementary reply submitted by the applicant/registrant should be consistent with the registration application materials submitted for the first time, and should correspond to the requirements of the "Medical Device Supplementary Reply Notice" and be explained separately.

2. The applicant/registrant must ensure that the content of the supplementary reply submitted is relevant to the requirements of the "Medical Device Supplementary Reply Notice" and ensure the authenticity and validity of the submitted information.

3. The applicant/registrant must ensure that the supplementary reply submitted is accurate in terms and clear in expression.

4. The process of issuing supplementary reply and returning supplementary reply only applies to the information scope submitted during this registration application, and the original application scope shall not be changed by supplementing the information.

5. If the applicant/registrant encounters a correction requirement that cannot be verified, confirmed or implemented during the reply process, the applicant/registrant should explain the reason in detail and provide scientific evidence.

Applicants/registrants should designate a person to be responsible for confirming the time limit for correction, making appointments and communications, preparing supplementary materials, etc., in order to improve the quality and efficiency of the supplementary materials. The designated person should have relevant professional knowledge and be familiar with the relevant laws, regulations and relevant review requirements for medical device registration. The applicant/registrant should try to ensure the continuity of the correction work and should not frequently change the designated person during the process.

Requirements for responding to notifications on supplementary reply for medical devices

When the applicant/registrant submits relevant supplementary information, he/she should also submit the "Supplementary Reply Contents Description" and the specific supplementary reply documents for the "Medical Device Supplementary Reply Notice".

1. Requirements for “Supplementary Reply Contents Description”

The "Supplementary Reply Contents Description" is a point-by-point explanation of all the issues in the "Medical Device Supplementary Reply Notice", which summarizes the correction ideas and supplementary reply files, explains the questions to be answered, and clarifies the names and locations of the supplementary reply files related to each issue.

(1) The applicant/registrant must explain the corresponding responses one by one according to the requirements of the "Medical Device Supplementary Reply Notice" without repeating or omitting any issues, and form a "Supplementary Reply Contents Description".

(2) The applicant/registrant must list the issues mentioned in the "Medical Device Supplementary Reply Notice" and outline how to respond to the supplementary reply request. If relevant supplementary reply is not submitted, an explanation and justification must be provided. The description of each relevant clause is recommended to include the following elements:

Briefly describe your understanding of the correction problem

Briefly describe your answering ideas or reasoning logic

The basis for the correction of the information

What objective evidence, documents, data or information are included

Description of special circumstances

(3) The “Supplementary Reply Contents Description” should clearly state the name of the supplementary reply file and its location in the “ table of content of RPS ”.

(4) If the change involves changes to the product technical requirements and/or instructions for use , the applicant/registrant shall provide detailed explanations under the corresponding questions in the “Supplementary Reply Contents Description”.

(5) If the applicant/registrant has other necessary supplementary documents beyond the requirements of the “Medical Device Supplementary Reply Notice”, they can describe them separately and specify the file name and location in the “Supplementary Reply Contents Description”.

2. Requirements for Supplementary Documents

(1) The applicant/registrant needs to select one of the following supplementary documents to respond based on the actual situation:

the information or data requested

Alternative information and explanation of why it would adequately resolve the issue

If the applicant/registrant believes that the supplementary reply requirements are irrelevant to the registration application or has doubts or objections to the supplementary reply requirements, they may submit relevant explanatory documents and explain the specific reasons and provide scientific evidence.

(2) Supplementary reply documents should be submitted item by item in the order of the supplementary reply requirements in the "Medical Device Supplementary Reply Notice". If multiple requirements point to the same supplementary reply document, it does not need to be submitted repeatedly and can be clearly stated in the "Supplementary Reply Contents Description".

(3) The format and signature requirements of the supplementary reply documents shall be consistent with those of the registration application documents.

(4) If necessary, it is recommended to give special markings (such as italics, bold, highlighted fonts, comparison tables, etc.) to the updated information in certain supplementary documents to highlight the changes and facilitate review.

Our analysis

Applicant/registrant = legal manufacturer

Medical Device Supplementary Reply Notice = questions by Chinese authority

Supplementary Reply Contents Description = abstract of answers by manufacturer

As in regulation mentioned even when manufacturer has no answers, try to write sound justification.

Use "Supplementary Reply Contents Description" to lead the thought of reviewer.

Do you know that designated person familiar to Chinese regulation can be outsourced to us EASYCHINAPPROV.

We have successful examples to represent your inexperienced distributor or new group in China to overcome deficiency stage which takes longer than preparation of dossier and review by authority.

Fast track of approved imported medical device

Fri, 13 Jun 2025 12:33:27 GMT

Production in China + approved imported medical device = Fast track at review and approval

Guidance of order 104 in 2020

In order to further implement the State Council's "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" and the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, implement the "delegation, regulation and service" reform and optimize the business environment requirements, comprehensively deepen the reform of the medical device review and approval system, promote the high-quality development of the medical device industry, and better meet the public health needs, the following matters are hereby announced regarding the production of products with imported medical device registration certificates by enterprises in China:

I. Scope of Application

This announcement applies to matters related to the production of Class II and Class III products with imported medical device registration certificates by foreign-invested enterprises established in China by registrants of imported medical devices.

II. Registration Requirements

(I) Foreign-invested enterprises established in China by registrants of imported medical devices shall, as registration applicants, submit domestic medical device registration applications to the drug supervision and administration department. In principle, the content of the registration application, except for the name, residence and production address of the registrant, shall be consistent with the relevant matters stated in the corresponding imported medical device registration certificate and its attachments.

(II) The applicant shall submit the registration application materials in accordance with the requirements of the Announcement on the Requirements for Registration Application Materials and the Format of Approval Documents for Medical Devices (Announcement No. 43 of 2014 of the State Food and Drug Administration) and the Announcement on the Requirements for Registration Application Materials and the Format of Approval Documents for In Vitro Diagnostic Reagents (Announcement No. 44 of 2014 of the State Food and Drug Administration).

Among them, the summary information, research information, clinical evaluation, product risk file of 1. medical device; raw materials (when applicable), production processes (when applicable), analytical performance evaluation, positive judgment value or reference interval determination, stability validation, clinical evaluation, risk analysis file of 2. in vitro diagnostic reagent products, and the original registration application materials of imported medical devices may be submitted. Import registrants and domestic registration applicants shall ensure the relevance and support of the above information to this registration application.

(III) The registration application procedure shall be implemented in accordance with the "Medical Device Registration Management Measures", "In Vitro Diagnostic Reagent Registration Management Measures" and relevant provisions on electronic submission of medical devices.

(IV) If the registration application is submitted and approved in accordance with the requirements of this announcement, the medical device registration certificate number of the relevant imported product that has been approved for registration shall be stated in the notes column of the registration certificate.

III. Quality management system verification requirements

The applicant shall ensure that the domestic production includes the main production process of the product, and promise that the main raw materials and production process will not change, and provide a self-inspection report that the product's domestic production quality management system complies with my country's " Medical Device Production Quality Management Standards " and a comparison report on the equivalence of domestic and foreign quality management systems. The drug regulatory authorities shall conduct a comprehensive review of domestic registration applicants in accordance with the medical device registration quality management system verification work procedures, focusing on the equivalence and traceability of domestic and foreign quality management systems, and whether the system changes brought about by the change of the production process will generate new risks and cause changes in registration matters.

IV. Post-market supervision requirements

Domestic registrants shall apply for medical device production licenses in accordance with the "Medical Device Production Supervision and Management Measures", strictly implement the main responsibility for quality and safety, and strengthen the quality management of medical devices throughout their life cycle; in accordance with the requirements of the "Medical Device Production Quality Management Standards", establish and improve the quality management system and ensure its effective operation.

V. Other aspects

For overseas registrants invested by Chinese enterprises that produce Class II and Class III medical devices in China that have obtained imported medical device registration certificates, this announcement shall apply for registration of the product.

For matters related to products that have obtained medical device registration certificates in Hong Kong, Macao and Taiwan, refer to this announcement.

This announcement shall take effect from the date of the announcement.

Annex: technical documentation of fast track (detailed req for payed gap analysis)

CH1.04 Application form

CH1.06 Quality management system, comprehensive quality system or other certification documents

CH3.3 Basic requirements (EP) for safety and effectiveness

CH6A.3.1 Product description information, CH6A.3.2 General production information (for medical devices) CH6B.6.3 Production and service control information (for in vitro diagnostic reagents)

CH3.4.1 List of standards (product technical requirements)

CH3.4.2 Declaration of conformity and/or certification

CH5.03 Label/instructions for use, CH5.02 Product/packaging label (for medical devices) CH5.3 Packaging instructions/instructions for use, CH5.2 Product/packaging label (for in vitro diagnostic reagents)

CH1.11.7 Declaration of conformity (for medical devices) CH1.11.6 Declaration of conformity (for in vitro diagnostic reagents)

* Testing report of type testing is needed in best practise

Original resource (history)

Imported medical devices are manufactured by enterprises in China

Adjust and optimize the production of imported medical devices in Chinese enterprises

Best practise

We have accompanied some manufacturers either to register „fast track“ approval of medical device or establish a production site with Chinese GMP .

Here are some lessons learned:

Legal entity (updated in 2025):

A foreign-invested enterprise can be an enterprise established by the registrant of imported medical devices, or an enterprise with the same actual controller as the registrant of imported medical devices. That is, the foreign-invested enterprise established by the registrant of imported medical devices, or with the same actual controller as the registrant of imported medical devices, can produce the second and third category products with the imported medical device registration certificate within the territory of the People's Republic of China.

Production:

The foreign manufacturer must have own production entity in China. Outsourced production of medical device is not allowed.

Legal manufacturer of new Chinese products should produce medical device.

A design transfer bw R&D and Chinese production is complex.

Product technical requirements must be represented in incoming -, in process – and final inspectio n of medical device. Otherwise a rational must be provided.

Registration:

Former Chinese certificate must be valid at time point of product submission.

Among technical documentation submitted to authority, the critical process of production workflow should not be changed.

T ype testing of medical device must be repeated in China.

Technical documentation

As listed above only 9 main chapters of TD are needed fr submission.

Do NOT forget that

Chinese name of product can be differant than original one
PTR/Type testing takes at least one year & CH 3.4.1
Product must be compliant with obligatory Chinese standards (GB and YY)

Quality management system:

A Chinese conform quality management system must be established. Parallel to product registration a Chinese GMP must be certified by authority.

A big challenge is how to transfer local QM system ( ISO 13485 or QSR ) to Chinese QM and how to have a design transfer from headquarter of manufacturer?

Tactic:

Person in management level with Chinese and overseas mind-set is asked. Chinese GMP and product registration must be at the same time prepared and approved. The interface between r egulatory affairs, R&D, product management and production must be cleared defined in a multi-parties project management.

A product variant to approved oversea s medical device must be differentiated.

What can we support

Besides the typical product registration and quality management system in production site in China, we can offer a free gap analysis based on your product status.

As the certificate is invalid, the cost of Chinese production is too much or no approved medical device is ever in China. There are always options as outsourced production to have made in china products to benefit from central value-based procurement.

Upon your customer need, we can be interim manager playing all roles in fast track project.

We could also offer a workshop in overseas or in China dedicate for intercultural and interdisciplinary communication for best regulatory and economic KP I.

Top 10 news in China in 2024

Wed, 01 Jan 2025 11:23:50 GMT

Top 10 news of medical device (IVD) in China in 2024

1. Medical device Act

Chinese authority NMPA made a draft of medical device act which will act as first law for medical device (IVD) in China. It replaces “ Regulations on the Supervision and Administration of Medical Device s”.

The medical act is more MDR-like in EU with its formulation, length and emphasis but for sure with Chinese elements.

We have following analysis. The speculation will take some years till final publication of medical device act.

11 chapters and 190 articles:

Chapter 1 General Provisions

Chapter 2 Medical Device Standards and Classification

Chapter 3 Medical Device Development

Chapter 4 Medical Device Production

Chapter 5 Medical Device Operation

Chapter 6 Import and Export of Medical Devices

Chapter 7 Use of Medical Devices

Chapter 8 Medical Device Alerts and Recalls

Chapter 9 Supervision and Management

Chapter 10 Legal Liability

Chapter 11 Supplementary Provision

Speculations:

-The law takes some years till final version

-new chapters: chapter 3 R&D, chapter 6 import and export, chapter 7 usage

-Strength of responsibility of legal representative (=chinese agent)

-Legal representative will be stricter qualified by having manufacturing or distribution licence

-Switch of medical device registration certificate possible

-Accelerate of review of clinical study and preference of multi-centre clinical trial

2. Main stream of medtech in China

In a Guideline for equipment renewal and technological transformation in key industrial sectors by government, for medtech is summarized with goal, policy, standards and main development direction.

Under main development direction these factors are written:

1. R&D and trial production equipment.

2. Complete machine manufacturing equipment.

3. Key component manufacturing equipment

4. Inspection and testing equipment.

5. Enterprise intelligent management system

6. Industrial operating system

7. Industrial software

3. Medical Equipment Procurement Analysis Report

There is an analysis report of procurement about country hospi tal (smaller than city). The power of procurement in Q1 in 2024 is decreased by almost 50% . However these types of product have a better quote than procurement of average products:

Radiotherapy equipment, surgical equipment and in vitro diagnostic equipment

The domestic products under Radiotherapy equipment is solely under 20% compared to imported products.

In the reports are also details about procurement of 3 tier hospitals, exact procured product and sum of typical medical device with name of manufacturers.

4. Revision of the Classification Catalogue of IVD

There is Revision of the Classification Catalogue of IVD in China which is valid in 2025 . Unlike 3 levels of product code of medical device, IVD has 2 levels, under 1th level 25 main groups, together with 2th level 1852 product code of IVD .

Besides it, we summaries:

• For IVD certificates approved and effective before January 1, 2025, they shall remain valid during the approved validity period.

• Starting from January 1, 2025, for IVD that have applied for registration for the first time, product registration applications shall be accepted in accordance with the Classification Catalogue.

• For extension registration applications that have been accepted before January 1, 2025, but have not yet been approved, continue to review and approve them in accordance with the original "Classification Catalogue" .

5. Chinese "Good distribution practise" takes effect

NMPA has revised guidance (valid as of July, 2024) of “ good distribution practise ” (GDP) since first publication in 2014. It applies to all Chinese distributors which are stated on Chinese label .

The details of new guidance are characterised with typical requirements of quality management system as international ISO 13485.

Besides Chinese GDP there is also a guidance of on-site inspection of medical device business quality management regulations which is essential to prepare inspection by authority.

Definition of failed inspection:

If the number of items that do not meet the requirements in key requirements is greater than 10% or the number of items that do not meet the requirements in general requirements is greater than 20% , the inspection result will be "failed inspection".

Important articles at GDP:

Article 12 : distributor of class II and III medical device should submit an annual quality report by each April

Article 14: make clear about assigned person in charge of the enterprise, person in charge of quality and the quality management personnel

6. Overseas inspection by Chinese authority NMPA in trend

Do you know that Chinese authority approaches overseas inspection at foreign manufacturer now after pandemic break?

We accompanied many inspections especially for manufacturer with his distributor as Chinese agent lacking regulatory and quality knowledge.

The focus is absolutely at production of approved medical device. The suggestion is to study given plan master file and checklist carefully. It will be asked items by items instead of providing an audit agenda.

See our article with full guidance of overseas inspection

7. Sampling inspection

Every year NMPA issues a list of inspection candidates in China. There are 66 medical devices in 2024. Among notification of inspection, manufacturer of medical device has to confirm sampling inspection, to pay for Chinese labs and to send device to lab in 5 calendar days.

There are three annexes in this year’s notification:

1. National Medical Device Sampling Variety Inspection Plan

2. List of national medical device sampling and re-inspection institutions (Download)

3. National medical device sampling and re-inspection work requirements

So far there are 5 notices of findings of local and foreign medical devices.

Dec , Oct , Sep , Jul , Jul

8. Usability validation

Finally NMPA issues guidance of usability of medical device. As usual there is unique risk-based must have usability validation of only some high-risk medical device, see the list.

Here some highlights:

· Usability validation of class II and III medical device is obligatory as 08.10.2024.

· Manufacturer has to update usability validation at change registration upon substantial changes to users or usage scenarios or user interfaces

· Under condition overseas usability validation of respective high risk devices could be accepted in China. Difference analysis report on usability engineering requirements between China and foreign countries is needed.

· There is need to mention usability items at Chinese instruction for use.

· For other medical devices (low class II and III) a usability validation or use error assessment report is needed

9. Chinese standards

There are special Chinese standards dedicated for medical device, abbreviated as YY or YY/T . YY means obligatory. In 2024 there are 90 revised YY standards in China.

We realize that overseas find quite difficult to find applicable standards, then applicable chapters in standards for product registration, followed by good translation in English and gap to higher edition of international standards.

Contact us for support as buying Chinese standards with English translation and gap analysis.

10. Learn Chinese regulation by yourself

It is not an advertisement or that we can not find 10th news in China. We want to encourage all stakeholders interested for Chinese market to actively learn our regulation und understand own product registration.

There are too many arising regulations in China, however it is besides language rational. Here are some important resources:

Database of approved medical device

Database of Chinese standard

CMDE learning online

Registration workflow

You can book sessions of our e-Learning to check learn Chinese regulation and global registration if you need our assistance.

Trace Chinese Registration

Wed, 11 Sep 2024 09:05:19 GMT

Traceability Matrix at Chinese Registration

Keywords

Digital tool, registration monitoring, submission assistent, submission compilation, digital project management, design transfer, AI translation, design history file, technical documentation, regulatory lean, regulatory science, matrix in reglatory affairs, feasibility of global registration, requirement traceability, risk management, clinical evaluation, NMPA, MDR, MDSAP, FDA

Why do you need traceability matrix for Chinese registration of medical device?

The easiest matrix at Chinese registration might be communication matrix in project, order and invoice.

We want to focus on some premium matrixs which are for manufacturer time - and budget consuming for success and play definitely a great role for compliant registration and follow up tracing next generation`s development of medical device (IVD).

We analysis the traceability matrix dedicated for foreign manufacturer who has a bit mind gap due to regulation and language difference to Chinese market.

We use the same mindset changing for another global regstration and international project using digila tool.

1. At whole development lifecycle

Key specifications are traced with user requirement, risk management, V&V, product description , Chinese IFU and Chinese testing

Design Change should be related to impact on new change registration, exact Chinese technical documentation, change comparison table , Chinese IFU, and even annual quality management report for overseas manufacturers

2. At registration dossier

Intended use should be consistent in Chinese certificate , Chinese IFU, device description, supporting evidence, and clinical evaluation.

Key risk requirement should be consistent in specification (and/or symbol and warning text) in Chinese IFU, label, verification and validation.

Especially at change registration , describtion should be consistent, risk management, labelling and evidence report should traced.

3. At review stage by Chinese authority

Deficiency question should be traced with exact chapter at t echnical documentation as reply, potential update in Chinese labelling and design history file (perhaps new feature in next product generation).

Ignored at authority is that deficiency at product regitration is best finding practise to correct mistake or improvement in running or palnned product realisation.

4. At post market after Chinese approval

One complaint or adverse event case can trigger risk management, CAPA, reporting in Chinese vigilance, part of annual quality management, periodic risk evaluation report and overseas inspection

One important requirement matrix: product technical document for Chinese type testing

Manufacturer of all classes medical device has to send device to test in a certified lab in China. As an important document for type testing is product technical documents (PTR) . It is very similar to input for safety, EMC or IEC 62304 etc. testing , however it will be drafted FIRSTLY by manufacturers with extreme summarised contents (less than 10 pages usually). The special features in PTR are:

• PTR is an input and output for Chinese type testing

• Manufacturers could actively define the specifications to test

• Obligatory Chinese standards require what and how to test

• Applied standard as method could be Chinese, international recognised or suggested by manufacturer

• Finalised PTR is part of technical documentation to submit to authority and acts as annex for Chinese certificate

• PTR is an important resource for design change after approval

There are 2 important chapters in PTR: chapter 2 performance specifications and chapter 3 method.

Each specification in chapter 2 is to match to corresonding method in chapter 3 . This is ignored by overseas manufacturers especially. These requirements should be controlled in the whole lifecycle of medical device, not just for registration.

Here is an example of PTR showing only 2 specifications : ( downlod the whole PTR and see other template s )

2.1 Working conditions

2.1.1 Environmental conditions

The working environment conditions of the product should be clarified, such as: ambient temperature, relative humidity, atmospheric pressure, etc.

2.1.2 Power supply conditions

The power supply voltage, frequency, resistance and power capacity of the product should be specified.

Shall comply with YY / T 0706-2017 of 5.2.1 requires clause.

2.2 Electric power

2.2.1 Maximum output power

The range of maximum output electric power should be specified.

Shall comply with YY / T 0706-2017 of 5.2.1 requires clause.

2.2.2 Nominal output power

The range of nominal output electric power should be specified.

Shall comply with YY / T 0706-2017 of 5.2.2 requires clause.

3. Testing method

3.1 Working conditions

Should meet the requirements of 2.1.

3.2 Electric power

3.2.1 Maximum output power

Press YY / T 0706-2017 the 6.2.1 test method provisions.

3.2.2 Nominal electric power

Press YY / T 0706-2017 the 6.2.2 test method provisions.

The specifications at testing of Chinese registration don’t come from nowhere. It is part of design and development , namely in design history file. So it can be traced with:

• user requirements

• verification and validation

• risk management

• applied standards

• design change

What can we support to manage Chinese PTR requirement?

There should be an intelligent testing matrix at Chinese registration with design and development at manufacturer.

It is ideally to have a PTR matrix in an electronic tool .

Contact us in term of PTR demo in a smart tool to manage your testing matrix. We have established a unique solution with partner ( Matrix Requirements ). We can adapt your internal user need, guarantee the testing in Chinese and international registrations and control design change at quality management.

Here a simplified example of Chinese type testing matrix requirement:

Other Matrix should be traced for a successful project

Either in China or in EU or global markets , manufacturer should always keep in mind to have different types of traceabilities between requirements, specifications, technical documents, international dossiers, deficiency reply within diverse communication parties .

It matters because a good matrix in medical device field would:

Make complex design and development transparent
Accelerate variant development upon the same product group
Leverage prioritised verification and validation in next product generation
Trace critical standards or regulations with actions
Evolve multi-department and multi-entity cooperation

Here is another matrix in aspect of design control (e.g. intended use) at quality management in post market.

Either for regulatory affairs (registration) in China or beyond, if you have a solid Excel or Word file with tracing items , have a free meeting with us. We will make a GRATIS matrix in customer project. You decide the next step and success.

Are you start-ups and do you want to start to establish a global regulatory affairs group?

You can also enroll our one year eLearning of regulatory affairs . We have special price.

Chinese standards in essential principle

Sun, 08 Sep 2024 12:32:24 GMT

Chinese standards listed in essential principle of Safety and Performance of medical device in 2022

Background

T here are two kinds of Chinese standards: national (GB) issued by the Standardization Administration of China (SAC), and industrial (YY) issued by NMPA. The non-binding or recommended character has prefix /T. Without /T it means obligatory. In general the version of Chinese standards is at developing stage. Most Chinese standards match the old version of harmonised international standards. There are three categories comparing international standards: identical (IDT), equivalent (EQV), or non-equivalent (NEQ).

So far there are so far 227 GB standards (93 obligatory and 134 recommended) and 1564 YY standards (303 obligatory and 1261 recommended).

In July, 2022 there is a new issued template essential principle of Safety and Performance of medical device in which the BASIC standards are listed. Paired to Chinese requirements and standards, the reference documents in defined TOC-chapter should be addressed in EP-list.

Meaning of Chinese standards

The standards depending binding or not binding is a regulation scale to establish quality management and development the medical device.

Standards are important parts in China to create design input, prepare product technical requirements prior to testing, and execute testing in product life cycle. Often the Chinese standard is mentioned in product specific guidance .

Unfortunately there is no year of standards in EP shown, we list not only the full standards but also corresponding international standards below.

GB Standard

GB 15213-2016 医用电子加速器性能和试验方法

Medical electron accelerators—Functional performance characteristics and test methods

GB 16174.1-2015 手术植入物有源植入式医疗器械第1部分: 安全、标记和制造商所提供信息的通用要求
GB 16174.2-2015手术植入物有源植入式医疗器械第2部分: 心脏起搏器

Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 14708-2:2005 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

GB 18278.1-2015 医疗保健产品灭菌湿热第1部分：医疗器械灭菌过程的开发、确认和常规控制要求
GB 18279.1-2015 医疗保健产品灭菌环氧乙烷第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求
GB 18280 .1 and .2 医疗保健产品灭菌辐射

ISO 17665-1:2006 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11135-1:2007 Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products—Radiation—Part 1：Requirements for development，validation and routine control of a sterilization process for medical devices
ISO 11137-2:2006 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

GB 4793.1-2007 测量、控制和实验室用电气设备安全通用要求
GB 4793.6-2008 测量、控制和实验室用电气设备的安全要求

IEC 61010-1:2001 Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 1: General requirements
IEC 61110-2-0-10:2005 Safety requirements for electrical for measurement, control, and laboratory use -- Part 6: Particular requirements for laboratory equipment for the heating of materials

GB 9706.102-2021 (YY 0505-2012)

IEC 60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic compatibility -- Requirements and tests

GB 9706.1-2020 医用电气设备第1部分：基本安全和基本性能的通用要求

IEC 60601-1:2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance

GB 9706.15-2008 医用电气设备第1-1部分：通用安全要求并列标准：医用电气系统安全要求

IEC 60601-1-1.2000 Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems

GB 9706.16-2015 医用电气设备第2部分：放射治疗模拟机安全专用要求

IEC 60601-2-29:2008 Medical electrical equipment—Part 2: Particular requirements for the safety of radiotherapy simulators

GB 9706.212-2020 医用电气设备第2-12部分：重症护理呼吸机的基本安全和基本性能专用要求
GB 9706.213-2021 医用电气设备第2-13部分：麻醉工作站的基本安全和基本性能专用要求

ISO 80601-2-12:2011 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13:2011 Medical electrical equipment—Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation

GB 9706.28-2006 医用电气设备第2部分: 呼吸机安全专用要求治疗呼吸机

IEC 60601-2-12:2001 Medical electrical equipment―Part 2: Particular requirements for the safety of lung ventilators―Critical care ventilators

GB/T Standard

GB/T 14233.1-2008 医用输液、输血、注射器具检验方法第1部分：化学分析方法
GB/T 14233.2-2005 医用输液、输血、注射器具检验方法第2部分：生物学试验方法

ISO 10993-4/5/6/10/11/12:2002 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods and Part 2: Biological test methods

GB/T 14710-2009 医用电器环境要求及试验方法

The environmental requirement and test methods for medical electrical equipment

GB/T 16886.16-2021 医疗器械生物学评价第16部分：降解产物与可沥滤物毒代动力学研究设计
GB/T 16886.17-2005 医疗器械生物学评价第17部分：可沥滤物允许限量的建立
GB/T 16886.18-2011医疗器械生物学评价第18部分：材料化学表征

ISO 10993-16:2017 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-17:2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials

GB/T 1809:2021 医用增材制造粉末床熔融成形工艺金属粉末清洗及清洗效果验证方法

Additive Manufacturing for Medical Applications: Verification Methods of Cleaning and Cleaning Effectiveness of Metal Powder Used in Powder-bed Fusion Process

GB/T 18268.1:2010 测量、控制和实验室用的电设备　电磁兼容性要求　第1部分：通用要求
GB/T 18268.26:2010 测量、控制和实验室用的电设备　电磁兼容性要求　第26部分：特殊要求体外诊断（IVD）医疗设备

IEC 61326-1:2020 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 1:General requirements
EC 61326-2-6:2005 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

GB/T 19974-2018 医疗保健产品灭菌灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求

ISO 14937:2009 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices

GB/T 20438.1-2017 电气/电子/可编程电子安全相关系统的功能安全第1部分：一般要求

GB/T 20438 series

IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems—Part 1:General requirements

GB/T 20918-2007 信息技术软件生存周期过程风险管理

Information technology—Software life cycle processes—Risk management

GB/T 4857.1-1992 包装运输包装件基本试验第1部分：试验时各部位的标示方法

ISO 2206:1987 Packaging—Basic tests for transport packages—Part 1:Identification of parts when testing

YY standard

YY 0709-2009 医用电气设备第1-8部分：安全通用要求并列标准：通用要求医用电气设备和医用电气系统中报警系统的测试和指南

IEC 60601-1-8:2003 Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

YY 1298-2016 医用内窥镜胶囊式内窥镜

M edical endoscope capsule endoscope

YY 9706.102-2021 医用电气设备第1-2部分：基本安全和基本性能的通用要求并列标准：电磁兼容要求和试验

YY 9706.108-2021 医用电气设备第1-8部分：基本安全和基本性能的通用要求并列标准：通用要求,医用电气设备和医用电气系统中报警系统的测试和指南

IEC 60601-1-8:2006+A1:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

YY 9706.247-2021 医用电气设备第2-47部分：动态心电图系统的基本安全和基本性能专用要求

IEC 60601-2-47:2012 Medical electrical equipment Part 2-47: Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems

YY/T 0316-2016 医疗器械风险管理对医疗器械的应用

ISO 14971:2007 Medical devices Application of risk management to medical devices

YY/T standard

YY/T 0316-2016 医疗器械风险管理对医疗器械的应用

ISO 14971:2007 Medical devices Application of risk management to medical devices

YY/T 0345.1-2011 外科植入物金属骨针第1部分：材料和力学性能要求

ISO 5838-1:1995 Implants for surgery — Skeletal pins and wires — Part 1: Material and mechanical requirements

YY/T 0681.12009 无菌医疗器械包装试验方法第1部分：加速老化试验指南

Y/T 0681 series

ASTM F 1980:02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages

Series of Test methods for sterile medical device Package

YY/T 0758-2021 治疗用激光光纤通用要求

General requirements for medical laser fiber

YY/T 0771.1 to .4-2020 动物源医疗器械第1部分:风险管理应用

Series of medical devices utilizing animal tissues and their derivatives

YY/T 0809.4-2018 外科植入物部分和全髋关节假体第4部分：带柄股骨部件疲劳性能试验和性能要求

ISO 7206-4:2010 Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components

YY/T 1276-2016 医疗器械干热灭菌过程的开发、确认和常规控制要求

ISO 20857:2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

YY/T 1463-2016 医疗器械灭菌确认选择微生物挑战和染菌部位的指南

Medical Device Sterilization Validation Guidelines for Selecting Microbial Challenge and Contamination Sites

YY/T 1464-2016 医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求

ISO 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

YY/T 1550.2-2019 一次性使用输液器具与药物相容性研究指南第2部分：可沥滤物研究已知物

Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 2: Leachable Known substance

YY/T 1730-2020 一次性使用血液透析导管

Hemodialysis catheter for single use

YY/T 1809-2021 医用增材制造粉末床熔融成形工艺金属粉末清洗及清洗效果验证方法

Additive Manufacturing for Medical Applications: Verification Methods of Cleaning and Cleaning Effectiveness of Metal Powder Used in Powder-bed Fusion Process

YY/T 9706.106-2021 医用电气设备第1-6部分：基本安全和基本性能的通用要求并列标准：可用性

IEC 60601-1-6:2010/AMD1:2013 Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

QM standards

GB 50457-2019 医药工业洁净厂房设计标准

Safety requirements for electrical for measurement, control, and laboratory use -- Part 6: Particular requirements for laboratory equipment for the heating of materials

YY 0033:2000 无菌医疗器具生产管理规范

Standard for the production management of sterile medical devices

YY/T 0287:2017 医疗器械质量管理体系用于法规的要求

ISO 13485:2016 Quality management systems

Standards in essential principles at IMDRF

In newly published guidance at IMDRF the following standards are mentioned. Please be aware that manufacturer should match standards more than given example depending on medical device type.

ISO 13485 ISO 14971 ISO 23640 ISO 24971 CLSI EP25
ISO 14155
ISO 10993 IEC 60601 IEC 61010
ISO 11135 ISO 11137 ISO 11138 ISO 11140 ISO 11607 ISO 10993 ISO 11737 ISO 13408 ISO 14644 ISO 14937 ISO 14698 ISO 17664 ISO 17665
IEC 60601 IEC 61010 IEC 62366-1 IEC/TR 62366-2 IEC 80001 ISO 80369 IEC 62304
IEC 62304
IEC 62366-1 IEC/TR 62366-2
ISO 15223-1 ISO 18113 ISO 20417
ISO 22442
CLSI EP05 CLSI EP06 CLSI EP07 CLSI EP12 CLSI EP17 CLSI EP21 CLSI EP25 CLSI EP28 ISO 17511 ISO 23640

Service of essential principles of Safety and Performance, Chinese standards (English translation and gap analysis)

Contact us to support monitoring, analysing Chinese standards and purchasing translated English version.

We have a full templates of new essential principle of Safety and Performance of medical device. We guide you to search applicable Chinese standards to your product group and justification if not.

Do you know that you have list Chinese standards in submission dossier, follow standards in Chinese local testing and provide test report in TD chapter 3 non-clinical verification?

If you want to learn more around EP and standards in Chinese registration, visit us our o n-demand workshop or 1 year online university with videos, script, learning case study and free consulting minute. We have customer tailored soluation and price.

Do you need a gap analysis of Chinese standard with IEC - or ISO standard ? You can contact us.

We have a translation team in China with records of translation for medtech manufacturers and at diverse fairs international.

Ask us to translate all Chinese regulation including guidance and GB, GB/T, YY- YY/T standards .

Example of guidlines

1. Guidelines for the biological evaluation and review of medical devices

2. Guidelines for the writing of registration and application materials for drug-containing medical device products

3. Guidelines for the division of medical device registration units

4. Guidelines for the technical review of mobile medical device registration

5. Guidelines for the technical review of the registration of animal-derived medical devices

6. Guidelines for the design of clinical trials of medical devices

7. Accept the technical guidelines for overseas clinical trial data of medical devices

8. Guidelines for the registration and review of medical devices for the prevention and treatment of rare diseases

9. Guidelines for the technical review of the registration of the service life of active medical devices

10. Guidelines for the technical review of the registration of medical devices for personalized additive manufacturing of passive implantable bones, joints and oral hard tissues

Examples of standards

1. YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices Part 2: Sterilization packaging materials Requirements and test methods

2 . YY/T 0681.12-2022 Test methods for sterile medical device packaging Part 12: Rubbing resistance of soft barrier materials

3 . YY/T 1812-2022 Characterization of physical and chemical properties of degradable biomedical metal materials

4 . YY/T 1813-2022 Medical Electrical Equipment Use Reliability Information Collection and Evaluation Method

5 . YY/T 1815-2022 Medical Device Biological Evaluation Application of Toxicological Concern Threshold (TTC) to Evaluate the Biocompatibility of Medical Device Components

6 . YY/T 1837-2022 Medical Electrical Equipment General Requirements for Reliability

7 . YY/T 1843-2022 Basic Requirements for Network Security of Medical Electrical Equipment

8 . YY/T 1833.1-2022 Artificial intelligence medical devices - Quality requirements and evaluation - Part 1: Terminology

9 . YY/T 1833.2-2022 Artificial intelligence medical devices - Quality requirements and evaluation - Part 2: General requirements for data sets

10 YY/T 0567.6-2022 Aseptic processing of healthcare products - Part 6: Isolator sy ystem

Clinical study of Class III medical device in China?

Sat, 07 Sep 2024 21:18:28 GMT

Medical device groups needed for clinical study (accepted overseas data or in China)

Background

If overseas legal manufacturers of class III medical device wish to register products in China, the first concern is whether a clinical study is needed or whether the overseas clinical study is accepted. It sounds like that there is no pass-by of registration of class III without clinical study in China.

Does class III medical device need clinical study in China? The answer is IT DEPENDS .

This is the reason that NMPA issues regularly a revised list of class III medical device which needs clinical study. The trend is that less medical device is listed and Chinese authority doesn’t require unnecessary clinical study in China.

The new list in 2020 for medical device III which need clinical stud y in China:

Implantable heart rhythm management device

Implantable cardiac pacemaker : usually consists of an implantable pulse generator and a torque wrench. Electrical pulses are applied to specific parts of the patient's heart through pacing electrodes. It is used to treat chronic arrhythmia. Resynchronization therapy pacemakers can also be used for heart failure treatment.

Implantable cardiac defibrillator : usually consists of an implantable pulse generator and a torque wrench. By detecting ventricular tachycardia and fibrillation, it is corrected by applying cardioversion / defibrillation pulses to the heart through electrodes. It is used to treat rapid ventricular arrhythmia. Resynchronization therapy defibrillators can also be used for the treatment of heart failure.

Implantable ventricular assist system

It usually consists of an implantable pump body, a power supply part, a blood vessel connection and a controller. It is used to provide mechanical support for blood circulation in patients with advanced refractory left heart failure, and is used for transitional treatment and / or long-term treatment before heart transplantation or recovery of heart function. It is used by medical institutions that have the conditions for heart transplantation and comprehensive postoperative nursing capabilities. Medical staff, out-of-hospital nursing staff and patients must pass corresponding training. Patients with intolerance to anticoagulation therapy are contraindicated.

Implantable drug infusion device

It usually consists of a drug perfusion pump, a reperfusion component and a catheter inlet component. This product is used in conjunction with an intrathecal catheter for long-term drug input.

Artificial heart valve and endovascular stent

Artificial heart valves or valve repair devices : generally made of polymer materials, animal tissues, metallic materials, inorganic non-metallic materials, and may or may not contain surface modification substances. Used to replace or repair natural heart valves.

Intravascular stents : stents are generally made of metal (including absorbable metal materials) or polymer materials (including absorbable polymer materials), and their structure is generally in the shape of a grid. The stent may or may not contain surface modification substances, such as coatings. It may contain pharmaceutical ingredients. For example, it is used to treat atherosclerosis and various vascular diseases such as stenosis, obstruction or occlusion.

Tissue engineering medical products containing living cells

Passive implantable tissue engineering medical products containing living cells that are mainly used as medical devices

Absorbable long bone internal fixation implantation device

Made of absorbable polymer material or absorbable metal material, it is suitable for internal fixation of long bone fractures of the limbs.

Legal manufacturers of above class III medical device have to conduct clinical study only if the subject devices have new designs, materials or mechanisms or scope of application and have higher risks to the human body.

In the fact, these 6 listed product groups represent a bit more products if man considers that under product group there are second and third level among product code (XX- YY - ZZ ).

Which are new class III medical devices removed from old list of MD needed for clinical study in 2020?

Compared to the last revision, these class III medical devices are exempted from clinical study in China:

1. Nano orthopedic implants used for support, fixation and replacement of bone and accessory tissues.

2. Orthopedic implants produced using additive manufacturing (3D printing) processes

This means, if legal manufacturers of medical device above had sufficient clinical data worldwide, a clinical evaluation can be provided.

What about requirements of other class III medical devices in term of clinical data?

In catalogue of product code it contains more than 400 class III medical devices in China. Around 200 class III medical device are in the list of medical device exempted from clinical study . It means that for the left 200 class III medical devices, clinical evaluation based on clinical data is possible.

However, what are possibilities to provide clinical data in China? As known there is clinical evaluation at submission dossier in China. Normally you have to compare to similar products or own previous device to prove that subject device is equivalent to similar device and has no safety and effectiveness concerns . These devices to be compared to must be approved in China and have same or similar intended use and technical characteristics . If any items between two devices differ, preclinical - and clinical data can be used to conclude that there is no safety and performance impairment.

Pathways of Chinese CER

1. CER based on exemption catalog (simplified)

The half of class III medical devices (around 200) as mentioned are in the list of medical device exempted from clinical study. Simplified comparisons to intended use described in the list and to similar device are sufficient.

2. CER based on equivalent or similar devices

(Conditional complicated)

If similar device approved in China was from competitors, normally you need a signed agreement with competitor to get the product info ( technical characteristics and clinical data ) of similar device with permission of competitors. Unfortunately it happens not often. So many manufacturers bought similar device and test technical characteristics of both devices to have detailed comparison table comply with clinical evaluation requirements in China.

Another resource to get competitors information is 510k summary at FDA where a comparison table already reveals intended use, scope of application and basic performance parameters etc.

3. Clinical study overseas (Moderate complex)

If data of overseas clinical study could be used , it is worthy to convince authority that the data is equivalent to Chinese population and there is no safety risk to Chinese patients.

4. Clinical study in China (Complex)

If medical device belonged to the new list above or it has no approved similar medical device in China to compare (or its Chinese certificate expired) or it has unique features bearing risk, a clinical trial at least partially in China is not to avoid. The details of procedure of clinical trial in China are described at NMPA official site .

Pathways of CER for 7 product groups explained by Chinese authority

In May, 2022, CMDE issues a notification of pathways of clinical evaluation for product groups. Depending on the best practice on the market, Chinese authority makes clear in the 7 lists, for each product code which of CER-pathway should be selected.

The listed 7 product groups:

11 Disinfection and Sterilization Devices of Medical Devices
12 Active Implantable Devices
13 Passive Implantable Devices
14 Injection, Nursing and Protection Devices
15 Patient Bearing Devices
17 Dental instruments
22 Clinical Examination Instruments

We hereby listed the detailed product codes among 13 Passive Implantable Devices which need clinical study overseas or in China:

13-02-02 Sports Injury Soft Tissue Replacement Implants
13-03-05 Intervertebral Disc Prosthesis
13-06-06 Intracranial stent system
13-06-11 Intracranial aneurysm blood flow guide device
13-07-01 Endovascular prosthesis
13-07-02 Vascular stent
13-07-02-03 Vena Cava Filter
13-07-04 Artificial blood vessel
13-07-06 Prosthetic heart valve and valve repair equipment
13-07-07 Heart Occluder
13-09-02 Injectable filler for plastic surgery
13-09-03 Breast Implants
13-09-07 Endobronchial valve
13-10-01 Acellular skin
13-10-02 Acellular dermal matrix
13-10-03 Collagen scaffold material
13-10-04 Nerve repair materials
13-10-05 Bone repair material containing recombinant human bone morphogenetic protein

Conclusion

Unlike the registration of class III and implantable medical device in EU and US , where a clinical study is usually inevitable, the entry of these medical devices into Chinese market is not that complex. The compelling overseas clinical study is a bonus point if clinical data of similar product for editing clinical evaluation is difficult to obtain.

So a regulatory gap analysis is essential for legal manufacturers of high risk medical device beforehand to register products in China. The first step is to determine Chinese product code . With product code it is possible to look up whether a clinical trial can be exempted . If not, another option is to search similar product approved in China. If the technical specifications of similar product were available, the typical way to provide clinical data is to edit clinical evaluation based on literature and clinical data in the other sources.

If an “innovative” class III medical device is out of scope of description of product code list in which clinical study is exempted or way different than similar product which is approved in China, a product variant with narrowed feature or intended use can be chosen in time at early stage of R&D to qualify for a clinical evaluation based on literature and available clinical data. This can avoid extensive clinical trial in China definitely.

Nevertheless there are still around 200 class III medical devices which can be struggled to use overseas clinical study and clinical data of similar device (combination of 2. Conditional complicated and 3. Moderate complex clinical evaluation.

E-Learning of Regulatory Affairs (Chinese registration and beyond)

Wed, 27 Mar 2024 15:03:02 GMT

Welcome to

E-learning of Chinese and global Compliance of medical device

Unique feature of E-learning

Free one to one supervisor with regular on demand meeting
Test and homework with professional personal examination and feedback
Possible expert opinion for current registration and other strategy
Update of new Chinese registration, videos and templates

Session 1: Chinese access
Session 2: Registration in China
Session 3: Chinese Post market and quality management
Session 4: Global markets
Session 5: Regulatory Affairs Soft Skills

E-Learning can be visited any time, valid for 1 year.

Participation possible any time, 24 hours a day, 7 days a week

Testimonials

Keyword

Medical Device, in vitro diagnostic, State Council Ordinance, China Food and Drug Administration National Medical Products Administration, NMPA, technical document, risk management, verification and validation, RPS, UDI, change registration, marketing authorization holder , overseas manufacturer, outsourced manufacturing , type testing, product technical requirement, clinical evaluation, instruction for use, labels, adverse event, vigilance, Quality management system, 医疗器械, 指导原则, 质量抽查, 说明书和标签, 体外诊断试剂, in vitro diagnostics, MDR, FDA, MDSAP, conformity assessment, ANVISA, Kaizen, global registration, regulatory intelligence, webinar, online university, template, on-demand workshop, roadmap, interim regulatory affairs, project management, product management, international product launch, ventre capital

Learning audience

Student and unemployed :

Basic knowledge for Chinese registration

Non Medtech personal :

Gain overview and tactic of Chinese market entry, useful for publication (medical writers)

Non Regulatory personal :

Perfect for career changer

Regulatory professionals :

Either with or without experience of Chinese registration, improve registration efficiency, ideal as boot camp for RA group

Leaning objective

Regulatory Affairs (registration) of medical device and IVD in China and beyond

Technical documentation in Chinese requirement

Start from EU and US to Chinese dossier

Quality management, quality assurance, project management, labelling, production, post market in term of Chinese registration

Intelligent Leverage of international registration

Soft skills of international regulatory affairs

Proof of E-learning

A certificate will be issued after successful test for each session and qualitative homework.

Example of one session in E-learning

In each session it is made of learning article, videos and test. Depending on your demand, you can ask for a supervisor minutes.

Open Videos to share knowledge

We try to share open sources of valuable video explaining the keys of Chinese and global regulation. The professionel version is coming up. Register as soon as possible because the early bird has cost benift and possibility to book trainer online.

Start: Participation possible any time.

Duration: 1 year

How to start: Kick off meeting with trainer, book training

End of E-Learning: for professional user there is test, free supervision hours and certificate

1. Insight of essential webistes with regulation of medical device and IVD

The following video share important Chinese websites where you can explore the different topics. Try to bookmark the links to monitor the useful contents using English translation.

2. In-country representative ( Chinese agent )

Do you know that you need an in-country representative in China to register your medical device or IVD? It has also a smart name "Chinese agent". It is similar to " US agent " and plays a greater role than authorised representative in EU preparing, submitting dossier, replying deficiency and assissting post market to authorit y. It has little to do with importer and distributor.

Watch the video and be clear finally with your Chinese partner.

3. Chinese certificate of medical device and IVD

The Chinese certificate covers the basic info as legal manufacturer, name of product, Chinese agent and certification number etc. The characteristic parts of Chinese Identity document (ID) of medical device and IVD are performance specifications at PTR. Altogether it acts as “Chinese ID” or “visit card” in Chinese commercialization after product approval.

Payment

It is payed at the beginning of eLearning, valid for 1 year.

Cancellation is possible in 14 days free and with refund of 80% course payment ( minus 20% ) in 2 months . The cancellation is not valid if more than 2 sessions in professional compliance module was completed or template was sent to client already.

The enrolment of course could be transferred to second person upon our approval.

Early bird cost: 19 % discount

Standard MyCompliance

999 EUR

· + 40 topics

· + 20 Videos

· Multi choices Test

· 90 Min free consulting (one to one)

Professional Mycompliance

1499 EUR

· + 40 topics

· + 20 Videos (Update)

· + 20 case study Assessment

· Multi choices Test

· Update of new Chinese regulation

· Free template + 10

· 200 Min free consulting (one to one)

Overseas inspection of medical device and drug by Chinese authority

Mon, 04 Mar 2024 20:22:48 GMT

Chinese authority expands inspection of medical device, IVD and drug overseas

Understanding the applied regulation of overseas inspection

After pandemic Chinese authority National Medical Products Administration (NMPA) starts to strength and start overseas inspection of manufacturer of drug and medical device. The applied regulation is Overseas Inspection of Pharmaceuticals & Medical Devices (No. 101 of 2018) made of 5 chapters. Especially annex 4 Listing of Site Master Files acts as a clear checklist of inspections unit:

Company overview
Company’s quality management system
Management of suppliers and contractors
Personnel
Plants and facilities
Equipment
Documentation
Production
Material storage management
Quality control
Sales, complaints, product defects and recalls
Internal audit
Brief description of the company’s product development management
Data authenticity statement

Common quality management items and process

If manufacturer has already ISO 13485 certification , it is surprisingly to see that Chinese Site Master Files can be one to one covered by ISO 13485. The inspection of Chinese authority is called also factory inspection. So the focus at overseas inspection is on the site of production , not too much on development.

The candidate of proved object is for sure procedures and record s around approved Chinese medical device .

The workflow of inspection is similar to any quality management with document review, factory visit and sampling inspection.

Typical Chinese quality management items

For sure Chinese authority is keen to knowing how to development, register, label, inspect (incoming, in process and end), place in Chinese market and monitor after Chinese approval .

The typical term for overseas manufacturers to learn by heart is:

Product technical requirement (PTR) : how to trace and show evidence to requirements on PTR
Chinese certificate: certification number and Chinese product name should be consistent in CRM system
Chinese instruction for use and Chinese label: compliant to labelling guidance
Post market surveillance : vigilance, annual quality management report and periodic risk evaluation report
Chinese design change of medical device : completed change registration, minor change assessed, quality management change

Strategic skill to pass Chinese overseas inspection

It is neither for Chinese authority nor overseas manufacturers routine what overseas inspection is after 3 years covid.

The key is to understand the regulation firstly followed by preparation of quality management with Chinese elements. For overseas manufacturers without Chinese entity, Chinese agent and Chinese distributor should assist to answer many regulatory and distribution questions.

Besides it, communication is critical during inspection. In best case you have some expert speaking your language and Chinese, knowing regulatory affairs and quality management. It is even suggested to have nice daily close up meeting and dinner together.

We are located in Germany and can support your overseas inspection anytime either as fully accompanied consultant or outsourced partner of your Chinese agent or Chinese distributor or pure inspection translator.

We could make a mock-audit beforehand and support on-site inspection with Chinese authority afterwards.

Write us to have a free briefing, receive kit of Chinese overseas inspection and book a meeting to start the preparation.

Regulations for the Administration of Overseas Inspection of Pharmaceuticals & Medical Devices (No. 101 of 2018)

Chapter I General

Article 1 This Regulations has been developed in accordance with the requirements of Drug Administration Law of the People’s Republic of China, Medical Device Regulations and applicable statutes to regulate the overseas inspection of pharmaceuticals & medical devices.

Article 2 This Regulations applies to the inspections of overseas processes in relation to the development and manufacturing of pharmaceuticals and medical devices that have been or are intended to be marketed within the territory of the People's Republic of China.

Article 3 For the purpose of these Regulations, overseas inspections of pharmaceuticals and medical devices refer to the inspections conducted by the National Medical Products Administration (“NMPA”) to confirm the authenticity, reliability and compliance of the processes related to the overseas development and manufacturing of pharmaceuticals and medical devices.

Article 4 The NMPA is responsible for the overseas inspection and management of pharmaceuticals and medical devices. Center for Food and Drug Inspection of NMPA (”CFDI”) is responsible for the specific organization and implementation of overseas inspections of pharmaceuticals and medical devices. Relevant departments handling inspection, review and evaluation of pharmaceuticals and medical devices assist in the conduct of overseas inspections.

Article 5 The NMPA discloses the basic situation and outcomes of inspection in accordance with the requirements of government information disclosure.

Article 6 Inspectors and the inspected organizations shall strictly abide by the anti-corruption requirements.

Article 7 Inspectors shall strictly abide by laws, regulations and inspection disciplines, and keep state secrets and the secrets of the organizations inspected.

Chapter II Inspection Tasks

Article 8 The NMPA determines the inspection tasks through risk assessment and random sampling taking into account recommendations of relevant departments on to-be-inspected products and their respective development and manufacturing sites. In the event a change in the inspection task(s) is indeed required due to regulatory purpose, adjustment(s) can be made to the inspection task(s) per provisions of the NMPA on management of foreign affairs involved in overseas inspection.

Where necessary as indicated, extended inspections can be conducted on the manufacturing sites, suppliers and/or other contract organizations of raw materials, excipients and/or packaging materials.

Article 9 The determination of inspection tasks shall consider risk factors in relation to medical products/medical devices such as registration review and approval, supervision and inspection, testing, complaint reports, and monitoring of adverse reactions and adverse events. Focus shall be placed on the following situations:

(I) Potential risks discovered during review and approval;

(II) Non-compliance of inspection or batch release, indicating that there are risks with the quality management system;

(III) Possible product safety risks as indicated by adverse reaction or adverse event monitoring;

(IV) Other violations of laws and/or regulations as indicated by complaint reports or other information;

(V) There are adverse records on the marketing approval holder, the medical device registrant or the filer (hereinafter referred to as “the holder”);

(VI) Presence of major problems with the holder's quality management system, as evidenced by the findings of on-site inspection(s) conducted by foreign regulatory authorities;

(VII) There is a need of inspection again after rectification;

(VIII) Other situations for which overseas inspections are required.

Article 10 The CFDI shall send Overseas Inspection Notice (Annex 1) to the holder or their agent based on the overseas inspection tasks of the NMPA. The holder shall submit to the CFDI Letter of Authorization (see Annex 2 for corresponding requirements) and Basic Information Form of Product under Overseas Inspection (Annex 3) within twenty (20) working days, and site master files and other materials required for the inspection based on the Listing of Site Master Files (Annex 4) within forty (40) working days, as of the date of receipt of Overseas Inspection Notice.

The CFDI may retrieve technical materials relating to the inspection of the varieties depending on the need of inspection, and the technical information obtained shall be maintained confidential through necessary measures, and shall be included in the inspection files after the inspection.

The holder must appoint a domestic agent (where the agent of medical device shall be the agent of the medical device registrant or the filer) and issue an authorization in accordance with the relevant requirements. The agent is responsible for the liaison between the medicine regulatory authority and the holder, undertakes adverse medicine reactions or medical device adverse event monitoring, and is responsible for product traceability and recall. The agent shall perform the relevant responsibilities and obligations of the medical devices for domestic marketed medicines as prescribed by laws and regulations, and assist the medicine regulatory authorities to carry out investigations on the overseas development of products, the inspection of production sites and violations of laws and regulations.

In the event of a change in the agent, the holder shall, after completing the change procedures stipulated by laws and regulations, delegate the new agent to submit a new Letter of Authorization to the CFDI in a timely fashion. Said Letter of Authorization shall clarify that the termination date of authorization for the outgoing agent shall be start date of authorization for the new agent.

Article 11 Upon receipt of Basic Information Form of Product under Overseas Inspection, The CFDI preliminarily determines an inspection schedule based on the overall arrangement of the inspection work and serves an Overseas Inspection Pre-notice (Annex 5) to the holder.

The holder shall not postpone the inspection without justification. In the event there is indeed a need to postpone the inspection due to special circumstances, a written application accompanied by justifications shall be submitted to the CFDI within ten (10) working days as of the date of service of Overseas Inspection Pre-notice. In such case, the CFDI determines the final inspection date by comprehensive evaluation of the actual inspection work to judge whether there is any situation that rejects or obstructs inspection.

Article 12 The inspection team shall in principle consist of more than three inspectors, and the inspection team shall implement responsibility system of team leader responsibility. The inspectors shall be persons who have obtained the inspector qualification in accordance with law. Experts in relevant fields can be invited to participate in the inspection work depending on the needs of inspection work.

Article 13 The holder shall coordinate and cooperate with the overseas inspection work in an all-round manner to ensure the smooth progress of the inspection, without delay, obstruction, evasion or refusal of inspection.

Article 14 The holder shall be responsible for communicating with the relevant inspected organizations (including overseas production plants, research and development institutions, manufacturing sites of raw materials, excipients and packaging materials, suppliers or other contract organizations, etc.) to coordinate and check related matters.

Article 15 The working language for overseas inspection is Chinese that materials such as application dossiers and rectification report submitted by the holder shall be in Chinese language. During the inspection period, translators who can meet the inspection requirements shall be provided.

Chapter III Inspection

Article 16 The CFDI is responsible for formulating the overseas inspection plan, and the inspection team shall conduct on-site inspections in accordance with the inspection plan. When a change to the inspection plan is required, the inspection team shall report to the CFDI for approval before implementation.

The CFDI shall provide the inspection team with centralized pre-departure education to emphasize the anti-corruption discipline and foreign affairs discipline.

Article 17 At the beginning of the on-site inspection, the inspection team shall convene an initial meeting to notify the inspected organization of the composition of the inspectors, the purpose and scope of the inspection, the inspection schedule, and state the inspection precautions and the discipline for inspection.

The inspected organization shall introduce to the inspection team the registration, production, and quality management of the product(s) to be inspected, and clarify the responsible person for the site inspection.

Article 18 During the inspection, the inspected organization shall maintain the normal production status, open relevant places and areas to the inspection team, and cooperate with the inspection of relevant facilities and equipment; according to the inspection schedule, the inspected organization shall arrange the dynamic production of the key production processes of the inspected varieties, timely provide the documents, records, electronic data, etc. required for the inspection, and truthfully answer the inquiries of the inspection team.

Article 19 The inspection team may collect relevant evidence materials by means of copying, photographing and video depending on the needs of inspection.

Article 20 If samples need to be taken during the inspection, the inspection team shall sample and seal the samples with reference to the sampling procedures and attach samples.

The sealed sample shall be returned to the territory by the holder with the sample file or brought back to the territory for inspection. The holder shall ensure that the packaging and shipping conditions of the sample are such that the quality of the sample is not affected.

Article 21 If the inspection team finds that there is a serious quality risk, it shall immediately report to the CFDI and propose preliminary disposal. After receiving the report, the CFDI shall conduct a risk assessment in a timely manner and report relevant results to the NMPA.

Article 22 Before the inspection comes to an end, the inspection team shall convene the final meeting to communicate the inspection outcomes and problems identified through inspection to the holder. The holder may state the defense and the inspection team shall keep documentation thereof.

Article 23 The inspection report shall be signed by the entire inspection team for confirmation and shall be submitted to the CFDI within ten (10) working days from the date of the inspection team returning to China.

Chapter IV Review and Handling

Article 24 After on-site inspection is completed, the CFDI shall feed Notice of Overseas Inspection Findings (Annex 6) back to the holder or their agent in writing within twenty (20) working days as of receipt of the inspection report submitted by the inspection team.

Where testing is required, the testing agency shall complete the testing or study within the statutory time limit from the date of receipt of the sample, and the time of testing or study shall not be counted in the time limit for feeding back Notice of Overseas Inspection Findings.

If any objections to the inspection outcomes, the holder may present a written statement or justification to the CFDI within ten (10) working days as of the date of service of Notice of Overseas Inspection Findings to the holder or their agent. Failure of the holder to provide such statement or justification within the specified time limit of ten (10) working days shall be deemed as no objections. The holder's statement and justification shall be included in the inspection file.

Article 25 The holder shall submit to the CFDI a report of rectifications for defects identified during overseas inspection within fifty (50) working days from the date of service of Notice of Overseas Inspection Findings. Where rectifications for the defects cannot be completed within the prescribed time limit, the holder shall submit a detailed improvement and follow-up plan followed by corresponding updates until all the rectifications have been completed.

Article 26 The CFDI shall conduct a comprehensive assessment of the on-site inspection report in conjunction with the rectifications made by the holder. The comprehensive assessment shall be completed within twenty (20) working days after receipt of the rectification report. The holder’s statement or justification, if any, may be considered together in the comprehensive assessment. If necessary as indicated, inspection may be re-initiated for the rectifications. In the event risk consulting or supplementation of materials by the hold is required during the process of comprehensive assessment, relevant time taken will not be counted in the aforesaid time limit.

Article 27 The comprehensive assessment shall adopt the principles of risk assessment taking into account the nature and severity of the defects and the product category to assess the inspection outcomes. The principle of judgment is as follows:

(I) Conforming: no defects were found during on-site inspection.

(II) Conforming after rectification: on-site inspection has found that there are corrective measures for all major defects and general defects, indicating that the holder is able to take effective corrective measures and organize production per laws, regulations and technical specifications.

(III) Non-conforming: on-site inspection of the pharmaceutical product has found problems of non-compliance with regulatory requirements and technical specifications, such as data authenticity, inconsistency of product quality-affecting critical elements with the registration materials, presence of serious defects, inadequate corrective measures for major defects, infeasibility of the rectification plan, etc.; ; on-site inspection of medical device has found problems of non-compliance with regulatory requirements and technical specifications, such as data authenticity, inconsistency of product quality-affecting critical elements with the registration materials, presence of serious defects, inadequate corrective measures for major defects, infeasibility of the rectification plan, etc.

Article 28 In any of the following circumstances, the holder shall be deemed to have delayed, obstructed, restricted or rejected inspection and be directly judged as “non-conforming”:

(I) Failure to provide the required authorization document(s) within the specified time limit after the date of service of Overseas Inspection Notice; failure to provide relevant documents and/materials required within the prescribed time limit;

(II) The holder obstructed or postponed the scheduled inspection twice;

(III) Refusal of the inspected holder to arrange for dynamic production;

(IV) Failure to cooperate with the procedures for overseas inspection;

(V) Failure to cooperate with an extended inspection;

(VI) The holder is found to delay, obstruct, restrict or reject the entry of the inspection personnel into the inspected place or area, or restrict the inspection time, or set unreasonable inspection conditions or disturb the inspection;

(VII) the holder is found to delay in providing or refuse to provide or deliberately cover critical information to be inspected;

(VIII) The holder is found to reject or restrict on-site collection of evidence-related materials, or refuse to perform notarization certification procedures or submit notarized certification documents for evidence-related materials;

(IX) Other circumstances that do not cooperate with the inspection.

Article 29 After comprehensive assessment, the CFDI shall form a report of overseas inspection review, which shall be submitted to the NMPA together with relevant inspection records and documents.

When discovering any potential major quality hazards requiring emergency measures in the on-site inspection report of the inspection team or during comprehensive assessment, the CFDI shall immediately send a report to the NMPA.

Article 30 For the varieties that are in the stage of registration review and approval or belong to the category of registration review and approval, the NMPA will, taking into the conclusion(s) from comprehensive assessment, adopt corresponding measures in accordance with Drug Administration Law of the People’s Republic of China, Medical Device Regulations, Drug Registration Regulations, Regulations on Medical Device Registration and Regulations on Registration of In vitro Diagnostic Reagents.

For the varieties that have been marketed in China, the NMPA will, with consideration given to the conclusion(s) from comprehensive assessment, order corresponding risk control measures against the holder, including interviews, making rectifications within a specified time limit, issuing a warning letter, suspending the filing of drug import customs clearance, suspending the import of the medical device involved, suspending the sale and use of the medical device involved, overseeing the product recall and even revoking import approval certificates.

If the comprehensive judgment is that the requirements are not met, and the inspection reveals that the enterprise has illegal activities or the product has potential safety hazards, the NMPA shall promptly adopt risk control measures and make information disclosure per law. For those who have major quality hazards and need to take urgent measures, the NMPA shall immediately take risk control measures and handle the case in accordance with law.

Article 31 In the case of discovering suspected violations of law, the inspectors shall fix the evidence in time, and the NMPA shall organize investigation and handling in accordance with law.

Article 32 The holder shall establish a product traceability system to ensure efficient recall of products being distributed and used in the country when product recall is required as evidenced by problems identified during inspection.

Article 33 After the risk factors are eliminated or rectifications have been made, the holder may submit an application to the NMPA for on-site inspection, which can be initiated again as appropriate after review. If the requirements of laws, regulations and technical specifications are met, the relevant risk control measures shall be lifted.

Chapter V Supplementary Provisions

Article 34 The on-site inspection of processes in relation to product development and manufacturing for holders located in the Hong Kong Special Administrative Region, the Macao Special Administrative Region and the Taiwan region shall be carried out in reference to this Regulations.

Article 35 On-site inspections for the raw material, excipient and/or packaging material manufacturing sites or suppliers of home-made products located outside China shall be conducted in reference to these Regulations.

Article 36 Site master files defined in this Regulations are part of the quality management system documents, describing the enterprise’s quality management policies and activities, the implementation of manufacturing and/or quality control of medical products/medical devices at designated sites, the performance of relevant operations in adjacent or nearby buildings etc.

Article 37 This Regulations shall be interpreted by the NMPA.

Annexes:

1. Overseas Inspection Notice

2. Relevant Requirements for Holder’s Authorization of Agency for Overseas Inspection Affairs

3. Basic Information Form of Product under Overseas Inspection

4. Listing of Site Master Files (for Pharmaceuticals / Medical Devices)

5. Overseas Inspection Pre-notice

6. Notification of Overseas Inspection Outcomes

Registration in Taiwan

Tue, 27 Feb 2024 13:30:04 GMT

Registration of medical device in Taiwan

Background of medical device branch in Taiwan

Taiwan is not huge in term of geography however one of the important market in Asia for most manufacturer. The market size was 2.7 billion $ in 2021 with 3% grow rate . Overseas manufacturer should not ignore Taiwan market with moderate registration demand, awareness of heath and an increased aging population.

There is predicate cost and time at site of authority. The language of submission dossier is in English. Taiwan registration has some Asian characters in term of structure of authority, legislative , however from the art of classification of products and quality management they are very western. For example for some of notified body in EU, Taiwan is a critical part at MDSAP inspectio n. So better to have a compliant Taiwanese QM and prepare technical documentation for product registration with same emphasis.

The responsible authority for food, drug, medical device and cosmetics is Taiwan Food and Drug Administration (TFDA) which is an important organisation of ministry of health and welfare. With the mission of "Safe and Effective Medicine, Safe and Healthy Food" and the vision of "Guardian of Food and Drug Safety Trusted by the Whole People, Creating a Safe Food and Drug Consumption Environment", the Department has established a sound food and drug safety management system and fulfilled the commitment of the Ministry of Health and Welfare to promote the health and well-being of the whole people. Under TFDA, the “center for drug evaluation” is similar like Center for Devices and Radiological Health in US under which devision of medical device make technical dossier evaluation and regulatory consultation.

The important regulation is medical device act under the Presidential Decree in 2021. There are 85 articles and 9 chapters.

The lifecycle of medical device in Taiwan is nicely illustrated by TFDA. The start is to classify your products and to search a local representative. For premarket application you might check whether a clinical trial is needed and which testing is required in the preparation stage. In parallel Quality System Documentation (QSD same as GMP or QM) should be applied. At post market surveillance it is obligatory to follow vigilance, safety surveillance (some high risk classes), good distribution practise and to implement UDI .

Premarket analysis of medical device in Taiwan

The prerequisite to mark medical device in Taiwan is home country approval. For registration you have to submit free sales certificate.

Time and cost to register product in Taiwan

There are initial-, change registration and renewa l in Taiwan. It is clear regulated regarding time and cost in term of these registrations (class I, II and III) as well QSD, determination of classification and innovative medical device. The time below in table is calendar day from the review of authority.

Classification of medical device in Taiwan

There are 3 classifications for medical device in Taiwan: I (low risk), II (medium risk) and III (high risk) . The classification can be matched with identification. The classification alphabetic character (A-P) plus 4 numbers is corresponding relevant classification. So there are 16 categories (classification number) according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty:

· Clinical chemistry and clinical toxicology devices

· Hematology, pathology, and genetics devices

· Immunology and microbiology devices

· Anesthesiology devices

· Cardiovascular devices

· Dental devices

· Ear, nose, and throat devices

· Gastroenterology and urology devices

· General, plastic surgery, and dermatology devices

· General hospital and personal use devices

· Neurological devices

· Obstetrical and gynecological devices

· Ophthalmic devices

· Orthopedic devices

· Physical medicine devices

· Radiology devices

If the classification of medical device is difficult or impossible to define, an application for determination for product classification can be made.

Local legal representative of medical device

To register medical device, it is essential to have a local representative. In some other countries it called Chinese agent, US agent, marketing authorisation holder in Japan or authorised representative in EU.

The local representative should have business license and medical device business permit. The role of local representative is universal the registration of dossier, communication with authority and oversee post market activities-

Premarket preparation to register medical device in Taiwan

Technical Dossier (application documents of class II and III medical device)

The following documents are needed as submission dossier:

· Free sales certificate

· Authorisation letter

· Test specification and methods

· Clinical evidence

· Radiation safety information

· Essential requirement

· Label, IFU and packaging

· Original licence

· Quality management certificate

· Product structures, materials, specifications, functions, intended uses and drawings

· Test specifications and methods of preclinical testing and quality control

Testing (e.g. NCC)

The most demanding testing is for products with wireless function . You`d better to have wireless components with new valid certificate under “national communication commission” (NCC). In this case you have to transfer the authorisation of medical device using wireless technology to local distributor. Otherwise you have to test the single wireless module and hardware. It is similar to FCC in US/Canada, RED in EU, MIC in Japan and KC in Korea . There are different accredited laboratory in Taiwan which make wireless tests. Plan the test independently to product registration so save for market entry in Taiwan.

We can be your interim testing project manager from application, plan to final certification.

Labelling

According to the “Medical Devices Act” Article 32, medical device firms that manufacture or import medical devices shall attach labels in traditional Chinese to the smallest packaging unit for sale and provide Chinese instructions before engaging in the sale, wholesale, and retail.

The following particulars shall be indicated on the labels, instructions, or packaging of medical devices:

1. Product name.

2. License number or listing number.

3. Effectiveness, intended use, or indications.

4. Date of manufacture and shelf-life or expiration date.

5. Model number, specifications, or major components.

6. Warnings, cautions, use limitations, or expected and foreseeable side effects.

7. Name and address of the license holder or the person who completed the listing.

8. Name and address of the manufacturer.

9. Lot number or serial number.

10. Other particulars that shall be indicated as announced by the central competent authority.

Instruction for use must be in traditional Chinese . The contents may include product description, indications/intended use (or purpose and function), warnings or precautions, side effects or complications, contraindications, model number and specifications. If the product involves accessories, the model number, quantity, and specification of accessories shall also be prepared. Contraindications, warnings, side effects and precautions must be accounted in detail and accurately, printed in rubic or boldtype font, or highlighted with a red frame.

We can control your international instructional for use fulfilling all country specific requirements.

Postmarket surveillance of medical device in Taiwan

So far there is only typical vigilance in Taiwan for all overseas manufactures. Only for some high risk classes there is safety surveillance report. Besides it, overseas manufacturers have to register UDI, make renewal for QSD, and take account of product design change during the next development of products.

Quality System Documentation (QSD) of medical device in Taiwan

Quality System Documentation is actually a premarket and continuous post market activity. The quality management certificate at product registration is not sufficient. Every 3 years you have to update quality management system in term of remote paper inspection.

QSD in Taiwan applies to all class II, III and some of class I medical device.

*for

There are simplified documents for TW-QSD if legal manufacturer has recent inspection audit in

EU/swiss/Lichtenstein (Only applicable for manufacturers located in countries of European Union and limited to EU Notified Bodies which participate in the “Technical Cooperation Program on Exchange of Audit Reports between EU and Taiwan”, or also applicable for countries/regions that have signed cooperative agreements with Taiwan),
Japan
US

Otherwise standard mode is required:

· Application form

· Quality system management as ISO 13485 or ISO 9001 or GMP at FDA (name revising:(

· Quality manual

· Quality system procedural documents

· Plant layout diagram

· Layout of production area

· Main manufacturing equipment and main testing equipment

· Manufacturing process diagram

Device Master Record

The last essential mode is also a kind of simplified dossier for which a list can be found at article 78 at

Medical Device Quality Management System Regulations (2021)

The certificate of QSD is 3 years. It is recommended to submit the next renewal six months prior to expiration of certificate.

Besides remote inspection every 3 years by Taiwan authority, the legal manufactures has to show compliant process and records at annual MDSAP inspection often.

Do you know due to Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports it is possible to get QSD certification for Taiwan at notified body in Europe?

Manufacturer has to expand scope of ISO 13485 covering special QM requirements in Taiwan only.

So far the following notified bodies are in the list:

1 Netherlands

DEKRA Certification B.V.

Notified Body 0344

2 France

GMED

Notified Body 0459

3 Germany

mdc medical device certification GmbH

Notified Body 0483

4 Germany

MEDCERT Prüfungs-und Zertifizierungsgesellschaft

für die Medizin GmbH

Notified Body 0482

5 Germany

TÜV Rheinland LGA Products GmbH (TRLP)

Notified Body 0197

6 Germany

TÜV SÜD Product Service GmbH

Notified Body 0123

We have close cooperation with some notified bodies in Germany and France. Contact us to keep QSD certificaion for Taiwan compliance and save inconvenience to apply QSD in Taiwan.

Do you know that without approval of renewal of quality management , manufacturer couldn`t import medical device till approval? QMS is categorised most likely risks in some countries for commercialisation of medical device.

With our global experience Device Master Record expecially for European manufacturer is one of the challenging documents which will be prepared more than 2 months including often deficiency reply by authority.

Below is one given example of Device Master Record für Taiwan.

Templates of QSD in Taiwan

Global registration of medical device and quality management

eLearning of global registration

UDI in Taiwan

The applied article of UDI is Nr.33 of the medical device act. TFDA announced that starting from June 1, 2022. License holders of Class III medical devices are required to upload UDI and corresponding product information to the UDI Database (UDID). Medical device manufacturers are also required to place UDI on the product label. In addition, starting from June 1, 2023, Class II medical devices are required to meet relevant regulations of UDI.

The regulation stipulates also the attribute to register in Taiwan UDID database.

Vigilance of medical device

Besides inofficial customer complaints, the legal manufacturer has to actively report serious adverse event and recalls. The regulations were updated in 2021. The deadline to report adverse events are as below:

7 days

Death.

Life-threatening condition.

15 days

Permanent disability.

Congenital anomaly of fetus or infant.

Requiring hospitalization or prolonged hospitalization.

Other complications that may result in permanent injuries.

There are three levels of recalls . There are different deadline to conduct a recall, a notification and to draft a recall plan.

Change assessment of medical device in Taiwan

After initial registration there is a critical post market assessment which is often underestimated: design change . Under significant change of product, you have to start a change registration before marking the new changed products in Taiwan.

The change guidance in Taiwan is quite straightforward without complex deciding trees. You just need to observe the typical significant changes as

· Chinese or English product name

· IFU, labelling and packaging

· Increase or decrease of variants

· Enhanced performance

· manufacturers name

· Production address

· New local representative

Important resource to register medical device in Taiwan

https://www.fda.gov.tw/eng/index.aspx

https://www.cde.org.tw/eng

https://www.ncc.gov.tw/english/index.aspx

https://www.ncc.gov.tw/english/

Do you know that with product code in Taiwan you can search regulatory requirements as standards, guidances and even approved competitor?

Do you want to have a professional regulatory affairs eLearning i n Taiwan and other markets?

Have a consulting with us for one year eLearning. We have a unique coach who can meet you and answer all questions.

Other similar international registrations

Medical device Act in Taiwan

Sun, 28 Jan 2024 16:03:14 GMT

Ministry of Health and Welfare

2020-01-15 by Ministry of Health and WelfareChapter I General Provisions § 1

Chapter II Management of Manufacturing and Sale § 13

Chapter III Listing and Registration and Market Approval of Medical Devices § 25

Chapter IV Management of Medical Device Clinical Trials § 37

Chapter V Management of Medical Device Advertisements § 40

Chapter VI Supervision and Prevention § 47

Chapter VII Investigation and Interdiction § 51

Chapter VIII Penal Provisions § 60

Chapter IX Supplementary Provisions § 75

Chapter I General Provisions

Article 1

This Act is established to ensure the safety, effectiveness, and quality of medical devices to be used by citizens, to promote the health of citizens, and to improve management of medical devices.

Article 2

For purposes of this Act, the term "competent authority" shall mean the Ministry of Health and Welfare at the central government level, the municipal governments at the municipal level, and the county/city governments at the county/city level.

Article 3

The term "medical devices", as used in this Act, shall refer to instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means:
1. Diagnosis, treatment, alleviation, or direct prevention of human diseases.
2. Modification or improvement of the structure and function of human body.
3. Control of conception.
Regulations governing the categories, risk classification, items, determination principles, and other related matters shall be established by the central competent authority.
Assistive devices covered by Subparagraph 2 of Paragraph 1 that are non-invasive, not expected to cause harm to the health of human body, and used without the assistance of medical personnel may be notified to the central competent authority for approval and exempt from being listed as medical devices of the preceding paragraph.
Assistive devices set forth in the preceding paragraph refer to appliances, equipment, instruments, and software that assist physically or mentally disabled persons to improve or maintain physical function and structure, to facilitate activity and participation, or to provide convenience to the attendance of their caregivers.

Article 4

The term "investigational medical devices", as used in this Act, shall refer to medical devices that are used solely in clinical trials and whose therapeutic effect and safety have not been verified.

Article 5

The term "medical device clinical trials", as used in this Act, shall refer to the systematic studies on the safety or effectiveness of medical devices carried out in human subjects by medical care institutions or institutions announced by the central competent authority (hereinafter referred to as "clinical trial institutions").

Article 6

The term "medical device advertisements", as used in this Act, shall refer to the act of publicizing the therapeutic effect of medical devices by means of communications for the purpose of soliciting and promoting the sale thereof.
Interviews, news reports, or propaganda containing information that implies or suggests therapeutic effect of medical devices for the purpose of soliciting and promoting the sale thereof shall be regarded as medical device advertisements.

Article 7

The term "labels", as used in this Act, shall refer to the words, graphics, or symbols displayed on a medical device or the packaging thereof.
The term "instructions", as used in this Act, shall refer to the related materials that describe information on product safety, effectiveness, and use of medical devices.

Article 8

The term "defective medical devices", as used in this Act, shall refer to medical devices which fall within any of the following circumstances after inspection or testing:
1. The occurrence of misdiagnosis is prompted or toxic or hazardous substances are contained, resulting in harm to the health of human body.
2. The normal and reasonable use in accordance with directions indicated on the labels or instructions is liable to cause danger or harm to the health of human body.
3. The duration of validity or storage life has expired.
4. The performance or specification is inconsistent with the content that has been approved in registration, listed, or announced as set forth in Paragraph 2 of Article 30.
5. The preservation is not in accordance with the storage conditions approved in registration.
6. Foreign objects that affect product quality are mixed or packed.
7. Other defects announced by the central competent authority.

Article 9

The term "medical device firms", as used in this Act, shall refer to medical device manufacturers or dealers.

Article 10

The term "medical device manufacturers", as used in this Act, shall refer to businesses that fall into the following two types:
1. Engaging in the manufacturing, packaging, labeling, sterilization, or final inspection and release of medical devices.
2. Engaging in the design of medical devices and marketing the devices under their name.

Article 11

The term "medical device dealers", as used in this Act, shall refer to businesses which engage in the wholesale, retail, import, export, rental, or repair of medical devices.

Article 12

The term "medical institutions", as used in this Act, shall refer to institutions applied for operation by medical personnel specified in Paragraph 1 of Article 10 of the Medical Care Act in accordance with the relevant regulations of professions and occupation laws and have been approved for practice.

Chapter II Management of Manufacturing and Sale

Article 13

Unless otherwise specified, those other than medical device firms shall not engage in the business activities specified in Article 10 and Article 11.
Any business with the intent to become a medical device firm shall file an application with the municipal or county/city competent authority for approval and registration, and shall start the operation only after having obtained the business permit. In case there are any changes made in the particulars registered, the firm shall apply for change of registration.
Medical device firms shall manufacture, sell, or supply medical devices at the registered place. Those who set up a separate manufacturing facility or business establishment shall file a separate application for medical device firm registration in accordance with the provisions of the preceding paragraph; however, those announced by the central competent authority shall not be required to apply separately for a medical device dealer permit at the business establishment or for selling or supplying medical devices at the registered place.
If the medical device firms set forth in the second paragraph do not have any company registration or business registration, they need to submit a consent letter from the competent authority of the target business.
Medical device firms set forth in the second paragraph shall join the trade association in accordance with the Industrial Group Act or Commercial Group Act.

Article 14

Those applying for being registered as a medical device manufacturer may also engage in such business as wholesale, retail, export, rental, or repair of its self-manufactured medical devices that have been listed or approved, or import of raw materials for their own use, without applying for a medical device dealer permit.
Pharmacies may concurrently engage in the retail business of medical devices of the classes announced by the central competent authority. Those who concurrently engage in the retail business of medical devices are applicable to the provisions governing the medical device dealers set forth in this Act, but may be exempted from applying for a medical device dealer permit.
Medical institutions for the necessity of conducting business may supply medical devices related to the business and may be exempted from applying for a medical device dealer permit. However, those who supply medical devices for patient use not as conducting business but for the sale or retail thereof shall nevertheless file an application for medical device firm registration in accordance with the provisions of Paragraph 2 of Article 13.

Article 15

Medical device manufacturers and dealers engaging in the import or repair shall employ qualified technicians according to the categories of medical devices.
Regulations governing the categories of medical devices, qualifications and proportions of technicians, the number of hours in education and training courses referred to in the preceding paragraph, and other related matters shall be established by the central competent authority.
If qualified technicians employed by medical device manufacturers and dealers engaging in the import or repair as specified in the first paragraph cannot perform their tasks due to dismissal, resignation, or other reasons and replacements are not employed separately, the competent authority shall order the medical device manufacturers and dealers to make corrections within a time period. Those who fail to make corrections within the time period shall immediately cease the manufacture, import, or repair of medical devices.

Article 16

To apply for suspension of business, medical device firms shall hand in medical device business permits and medical device licenses to the municipal or county (city) competent authority, who is to note clearly on business permit the reason and term of suspension and to return them once the resumption of business is approved. Each period of suspension shall not exceed one year.
Medical device firms shall apply for resumption, continued suspension, or termination of business before the period of suspension expires. For those who fail to apply upon the expiration period and after being verified by the municipal or county (city) competent authority that no business is actually in operation at the original address, the original issuing competent authority shall cancel their related permits and licenses.
When medical device firms apply for termination of business, medical device business permits and medical device licenses they have obtained shall be handed in at the same time for cancellation. Those which are not handed in for cancellation shall be cancelled by the original issuing competent authority.
For those who violate the provisions of this Act and are subject to suspension of business imposed by the competent authority, their permits and licenses shall be handed in, noted clearly, and returned in accordance with the provisions of the first paragraph.

Article 17

Medical device firms shall not purchase or rent medical devices that have not been registered and approved or listed or are supplied by non-medical device firms.

Article 18

The central competent authority may announce categories and items of specific medical devices with restriction on their sale or supply type according to the risk of using such medical devices.

Article 19

For medical devices with certain risk class as announced by the central competent authority, medical device firms and medical institutions shall establish and maintain data on direct supply sources and flow of products.
For product items announced by the central competent authority, data established and maintained according to the preceding paragraph shall be reported to the central competent authority.
Regulations governing the scope, methods for establishment and maintenance of data, retention period, report contents and methods referred to in the preceding two paragraphs, and other matters to be complied with shall be established by the central competent authority.

Article 20

The facilities, equipment, and sanitary conditions of medical device manufacturers shall comply with the Establishment Standards for Medical Device Manufacturers.
The Establishment Standards for Medical Device Manufacturers set forth in the preceding paragraph shall be jointly prescribed by the central competent authority and central industry competent authority.

Article 21

Medical device manufacturers in Subparagraph 1 of Article 10 shall carry out factory registration pursuant to the Factory Management Act, except when exemption from factory registration is allowed pursuant to the Factory Management Act, or if such manufacture, as approved by the central competent authority, is for research and development purposes.

Article 22

Medical device manufacturers shall establish a medical device quality management system governing the on-site facilities, equipment, organization and personnel, production, quality control, storage, logistics, customer complaints, and other matters and shall comply with the quality management system regulations.
Medical device manufacturers shall establish a medical device quality management system in accordance with the provisions of the regulations set forth in the preceding paragraph, and the manufacture may only begin after receiving a compliance inspection by the central competent authority and obtaining a manufacturing license. However, product items announced by the central competent authority shall not be required to obtain a manufacturing license.
The provisions of the preceding two paragraphs shall apply mutatis mutandis to overseas manufacturers importing medical devices, and the central competent authority shall send personnel to the premises of such overseas manufacturers for inspection on a periodic basis or as necessary.
The quality management system regulations set forth in Paragraph 1 and regulations governing the content and methods of inspection, the requirements, procedures, review, issuance, validity period, change, revocation, or cancellation of approval referred to in Paragraph 2, and other matters to be complied with shall be established by the central competent authority.

Article 23

Medical device manufacturers shall not commission other manufacturers to manufacture or accept the commissioning to manufacture medical devices, unless otherwise approved by the central competent authority.
Medical device dealers shall not manufacture medical devices. However, this shall not apply to those approved by the central competent authority to commission other medical device manufacturers for the manufacture.
Regulations governing the application documents, product liability, contractual provisions, labeling, packaging for the commissioning of manufacture referred to in the preceding two paragraphs, and other operation related matters to be complied with shall be established by the central competent authority.

Article 24

For medical devices announced by the central competent authority and their dealers, a medical device good distribution system shall be established to govern the product storage, distribution, services, personnel deployment, and other related operational matters, and shall comply with the regulations for good distribution practice of medical devices.
Medical device dealers shall set up a good distribution system of medical devices in accordance with the regulations set forth in the preceding paragraph, and the wholesale, import, or export may only begin after receiving a compliance inspection by the central competent authority and obtaining a distribution license.
Regulations for the good distribution practice set forth in Paragraph 1, and regulations governing the content and methods of inspection, the requirements, procedures, review, issuance, validity period, revocation, or cancellation of approval referred to in the preceding paragraph, and other matters to be complied with shall be established by the central competent authority.

Chapter III Listing and Registration and Market Approval of Medical Devices

Article 25

For the manufacture and import of medical devices, an application shall be filed with the central competent authority for registration and market approval. No manufacture or import shall be allowed until such approval is granted and a medical device license is issued. However, the manufacture and import of product items announced by the central competent authority shall be done by means of listing.
Medical devices that shall apply for registration and market approval in accordance with the preceding paragraph shall not do so by means of listing.
The import of medical devices shall be done by license holders, those who have completed the listing, or their authorized persons.
If the medical device that shall be listed in accordance with the exception of Paragraph 1 has obtained medical device license approval before this Act becomes effective, the central competent authority shall complete the listing directly, cancel the original license, and notify the original license holder.

Article 26

Alteration may only be made to any of the particulars of registration and market approval or listing pertaining to any medical device designated by the central competent authority after approval of the central competent authority is obtained.

Article 27

A medical device manufacture or import license is valid for a period no longer than five years starting from the date of issue. Where it is necessary to continue the manufacture or import upon expiration, a prior application shall be filed with the central competent authority for approval of license extension. Each extension shall not exceed five years. For those who fail to file an application upon the expiration period or if the extension is disapproved, the original license shall become invalid and be cancelled by the central competent authority.
In case the license set forth in the preceding paragraph can no longer be used due to stain or damage, an application shall be submitted along with the original license to the central competent authority for replacement. In case of loss, an application for re-issuance shall be filed.

Article 28

Medical device firms that have completed the listing of medical devices shall file an annual declaration with the central competent authority each year. For those who fail to file a declaration within the time period, the original listing shall become invalid. This shall also apply to the medical devices subject to direct listing as stipulated in the provisions of Paragraph 4 of Article 25.

Article 29

Regulations governing the following related matters shall be established by the central competent authority:
1. Requirements, procedures, and review guidelines in regard to the application for registration and market approval and issuance of license or listing of medical devices in accordance with the provisions of Article 25.
2. Requirements and procedures in regard to the application for alteration of the particulars of registration and market approval or listing in accordance with the provisions of Article 26.
3. Procedures in regard to the application for extension, replacement, and re-issuance of licenses in accordance with the provisions of Article 27.
4. Procedures in regard to the annual declaration in accordance with the provisions of the preceding article.

Article 30

Medical device product items designated by the central competent authority shall comply with specific specifications and performance.
The product items, specifications, test methods, and performance of medical devices referred to in the preceding paragraph shall be announced by the central competent authority. If a test method has not been established, an internationally recognized method may be adopted; if there is no internationally recognized test method, the suitability thereof shall be demonstrated.

Article 31

The central competent authority, with regard to data submitted by medical device firms for registration and market approval or listing that are information related to trade secret or business operation, shall restrict them from being made available to the public or provision. However, this shall not apply to information that is necessary for the public benefit or protection of the health of human body.

Article 32

Medical device firms that manufacture or import medical devices shall attach labels in Chinese to the smallest packaging unit for sale and provide Chinese instructions before engaging in the sale, wholesale, and retail. However, this shall not apply to those announced or approved by the central competent authority due to the difficulty in compliance.

Article 33

Medical device firms shall indicate the following particulars on the labels, instructions, or packaging of medical devices, as approved, registered and approved, or listed in accordance with Paragraph 2 of Article 13 and Paragraph 1 of Article 25. However, this shall not apply to those exempt from such indication as announced by the central competent authority:
1. Product name.
2. License number or listing number.
3. Effectiveness, intended use, or indications.
4. Date of manufacture and period of validity or shelf-life.
5. Model number, specifications, or major components.
6. Warnings, cautions, use limitations, or expected and foreseeable side effects.
7. Name and address of the license holder or the person who completed the listing.
8. Name and address of the manufacturer.
9. Lot number or serial number.
10. Other particulars that shall be indicated as announced by the central competent authority.
For specific medical devices announced by the central competent authority, the instructions set forth in the preceding paragraph may be replaced by electronic instructions.
In addition to the indication specified in the first paragraph, medical devices that are necessary to provide braille characters or other sufficient information for ease of reading as a supplementary measure shall be announced by the central competent authority.

Article 34

Manufacturers exporting domestically manufactured medical devices to foreign countries may apply to the central competent authority for certificates required by the countries where such medical devices are to be exported.
Medical devices set forth in the preceding paragraph may be restricted for export when the central competent authority deems that there is a concern of insufficiency to meet domestic demand.
Medical devices that are approved to be manufactured for export only shall not be sold domestically. However, this shall not apply when the central competent authority deems that there is a concern over domestic demand.
Medical device firms holding licenses of necessary medical devices announced by the central competent authority shall, in the case of incapable to continue to manufacture, import, or the likelihood of insufficient supply of said medical devices, report to the central competent authority at least six months in advance; and shall, if unable to report within the aforementioned period due to natural disaster or other incidents not attributable to the medical device firms, report to the central competent authority within 30 days after occurrence of such incidents.
The central competent authority may, upon receiving the report set forth in the preceding paragraph or becoming aware of the likelihood of insufficient supply of necessary medical devices, register it on a public website.

Article 35

The central competent authority may grant special approval for manufacture or import of specific medical devices without the limitations set forth in Paragraph 1 of Article 25 if any of the following circumstances applies:
1. For the purpose of preventing, diagnosing, or treating life-threatening or severe disability diseases, with appropriate alternative treatment not yet available domestically.
2. The necessity of responding to emergency public health circumstances.
3. Investigational medical devices.
4. For the exclusive use as samples or gifts, or for personal use.
5. Where the import thereof is for the exclusive purpose of repair, and not for circulation or sale domestically after the repair is completed.
6. Where circumstances exist for incapable to continue with the manufacture, import, or for insufficient supply of licensed products that have been announced as necessary medical devices in accordance with Paragraph 4 of the preceding paragraph.
Regulations governing the application requirements, review procedures, approval criteria, restrictions on supply and sale, return, and other matters to be complied with in regard to the special approval referred to in the preceding paragraph shall be established by the central competent authority.

Article 36

If any of the following circumstances applies to the medical devices for which special approval for manufacture or import has been obtained as set forth in the preceding article, the central competent authority may cancel their approval and order the applicant to take action on or recall the said medical devices within a time period:
1. An appropriate alternative treatment becomes available.
2. The public health emergency situation is over.
3. There is concern about the safety or therapeutic effect as evaluated and confirmed by the central competent authority.

Chapter IV Management of Medical Device Clinical Trials

Article 37

Clinical trial institutions or trial sponsors shall file an application with the central competent authority and obtain its approval before initiating any clinical trial. However, this shall not apply to those that do not involve significant risks as announced by the central competent authority.
Clinical trial institutions implementing clinical trials of the preceding paragraph shall exercise the necessary duty of medical care, and shall obtain consent from human subjects except in the case of emergencies.
Regulations governing the scope of management, operational practices, application procedures, review guidelines, avoidance of conflicts of interest, information disclosure, supervision and administration, inspection, particulars of the content of informed consent referred to in the preceding two paragraphs, and other matters to be complied with in regard to medical device clinical trials shall be established by the central competent authority.

Article 38

Clinical trial institutions and trial sponsors shall report to the central competent authority when the human subject of a medical device clinical trial experiences any of the following occurrences during implementation of the clinical trial:
1. Death.
2. Life-threatening condition.
3. Temporary or permanent disability.
4. Congenital anomaly of fetus or infant of the human subject.
5. Requiring hospitalization or prolonged hospitalization.
6. Other complications that may result in permanent injuries.
Clinical trial institutions shall report to the central competent authority when the human subject experiences any of the occurrences in the preceding paragraph after termination of the clinical trial and when the occurrence is related to the clinical trial.
The reporting set forth in the preceding two paragraphs shall be made within seven days after becoming aware of the actual happening of the occurrence, and detailed investigation information shall be submitted to the central competent authority within fifteen days for recordation.

Article 39

In the event that the central competent authority deems there is concern that a medical device clinical trial may cause harm to the health of human body, it may order trial institutions to suspend or terminate the trial or to adopt other necessary measures.

Chapter V Management of Medical Device Advertisements

Article 40

Businesses other than medical device firms are not allowed to engage in advertising of medical devices.

Article 41

In the event that a medical device firm wishes to publish or broadcast a medical device advertisement, the license holder or the person who has completed the listing shall, before publishing or broadcasting, submit all texts, pictures, or speeches constituting the advertisement to the municipal competent authority if the medical device firm is located in a municipality, or to the central competent authority if it is located in a county (city), for approval.
During the approved period of publishing or broadcasting, no modification or alteration of the approved content of a medical device advertisement shall be allowed.
If the original approving authority finds that the content of an approved medical device advertisement or the way it is published or broadcast violates the provisions of the preceding paragraph or may cause harm to the health of human body, it shall order the medical device firm to immediately stop publishing or broadcasting the said advertisement or to make corrections within a time period. For those who fail to make corrections within the time period, their approval shall be cancelled.
The authority imposing the disciplinary action set forth in the preceding paragraph shall notify with a copy to the mass media enterprises publishing or broadcasting the advertisement of the action.

Article 42

No mass media enterprise shall publish or broadcast any medical device advertisement which has not been approved by the central or municipal competent authority, whose content is different from the approved content, which has been cancelled, or for which an order has been issued to immediately stop publishing or broadcasting or to make corrections within a time period but no corrections have been made.
A mass media enterprise that is commissioned to publish or broadcast an advertisement shall preserve the name, number of the identification document or business registration certificate, domicile, firm, or business office, telephone number, and other relevant information for six months following the last date of advertisement, and shall not evade, impede, or refuse any request by the competent authority for such information.

Article 43

The validity period for a medical device advertisement approval document shall be three years, starting from the date of issue. Where it is necessary to continue advertising upon expiration, an application for extension shall be filed with the original approving authority six months before the date of expiration. Each period of extension shall not exceed three years.

Article 44

In the event that the medical devices shall be used by medical personnel as stated in the instructions or announced by the central competent authority, the advertisements of such medical devices shall be published only in the medical publications, mass media, or related medical academic activities that are for the exclusive participation of medical personnel.

Article 45

Medical device advertisements shall not be made in the following manners:
1. To be publicized in the name of others.
2. To warrant the effectiveness or performance by making use of books and periodicals, documents, or data.
3. To be publicized by means of interviews or news reports.
4. To be publicized by any other improper means.

Article 46

Labeling or promotion of therapeutic effect for non-medical devices shall not be allowed. However, this shall not apply if it is otherwise provided in other laws.

Chapter VI Supervision and Prevention

Article 47

The central competent authority may designate product items and specific time periods for medical devices that have been approved for manufacture or import or have completed the listing, and order medical device firms to monitor their safety according to the announced or approved safety monitoring plan. Medical institutions shall provide medical device firms with relevant safety monitoring data.
Medical device firms set forth in the preceding paragraph shall prepare and submit safety monitoring reports to the central competent authority periodically. For those who fail to submit safety monitoring reports periodically or whose products have safety concern as deemed by the central competent authority, or if the methods and content for implementation of the safety monitoring plan do not comply with the original announcement or approval, they may be ordered to make corrections within a time period or extend the monitoring period. When necessary, they may be ordered to suspend the manufacture, import, or sale. If the circumstances are severe, their licenses or listings may be directly cancelled.
Regulations governing the methods of submission, time period, contents, formats, restriction and maintenance of the collected data, monitoring period, evaluation referred to in the preceding two paragraphs, and other related matters in regard to the safety monitoring data and reports shall be established by the central competent authority.

Article 48

Medical device firms or medical institutions shall report any serious adverse events caused by medical devices to the central competent authority.
Regulations governing the conditions, reporting methods, time period, contents, and other matters to be complied with in regard to the serious adverse events referred to in the preceding paragraph shall be established by the central competent authority.

Article 49

Upon the finding that a medical device is likely to cause harm to the health of human body, the holders of the medical device license or those who have completed the listing shall immediately and proactively report to the central competent authority and undertake corrective and preventive measures.
The corrective and preventive measures set forth in the preceding paragraph include preparation of advisory contents, replacement of parts and accessories, product testing, suspension of use, product recall, or other necessary measures, and shall be disclosed in a reasonable manner for awareness of medical institutions, medical device firms, and users.

Article 50

If there is concern about the safety or therapeutic effect of medical devices that have been approved for manufacture or import or have completed the listing, as re-evaluated and confirmed by the central competent authority during the period of validity of their manufacture or import license or listing, medical device firms may be ordered to make corrections within a time period. When necessary, they may be ordered to withdraw, recall, or suspend the manufacture, import, or sale. For those who fail to make corrections within the time period or if there is a serious safety concern, their licenses or listings may be cancelled.

Chapter VII Investigation and Interdiction

Article 51

The competent authority may send officials to inspect the facilities and relevant business operations of medical device firms or medical institutions, and may randomly test their medical devices. Those being inspected shall not evade, impede, or refuse. The quantity of test samples to be taken shall be limited to the extent sufficient for use in testing, and receipts shall be given to business operators.

Article 52

Medical device product items designated by the central competent authority shall only be released after passing random inspections or tests at the time of import.
Regulations governing the product items and the items, modes, methods, scope, fees for random inspection and testing of medical devices referred to in the preceding paragraph, and other related matters shall be established by the central competent authority.

Article 53

The municipal or county (city) competent authority shall conduct a census of medical device firms at least every two years, to which the medical device firms shall not evade, impede, or refuse.

Article 54

If the central competent authority finds that a medical device is likely to cause serious harm to the health of human body, it shall immediately prohibit its manufacture or import, and may cancel its medical device license or listing. As for such medical device that has been manufactured or imported, its export, sale, supply, transport, storage, brokerage, transfer, or display with the intent to sell shall be prohibited for a time period. Such medical device may be confiscated and destroyed if necessary.

Article 55

Regarding medical devices suspected to have not been registered and approved or listed or to be defective medical devices, for medical devices that have not been registered and approved or listed, the municipal or county (city) competent authority shall first place them in confinement at the site and take samples for inspection or testing before taking further actions. For defective medical devices, the authority may first place them in confinement at the site and take samples for inspection or testing before taking further actions. As for those which have caused serious harm, they shall be confiscated and destroyed after reporting for approval to the central competent authority.
The quantity of the samples set forth in the preceding paragraph shall be limited to the extent sufficient for use in inspection or testing, and receipts shall be given to business operators.
For medical devices set forth in Paragraph 1, the competent authority may notify or announce the withdrawal, cessation of use, or suspension of the manufacture, import, or sale thereof.

Article 56

In the case of any defective medical device or medical device that has not been registered and approved or listed, the following measures shall be undertaken according to the circumstances in addition to the actions to be taken under applicable provisions of this Act:
1. For those that manufacture or import medical devices that have not been registered and approved or listed or that use the licenses of others, the original approving authority may cancel all or part of their medical device licenses or listings, medical device business permits, medical device manufacturing licenses, or registered particulars regarding the company, business, or factory.
2. For those that sell or display with the intent to sell medical devices that have not been registered and approved or listed, a sales ban shall be imposed. In the case of repeated violation, their business operations may be suspended.
3. For those that manufacture, import, sell, or display with the intent to sell defective medical devices, in the case of a serious violation or repeated violation, the original approving authority may cancel all of their medical device licenses or listings and medical device manufacturing licenses, or may suspend their business operations.
The competent authority may announce the name, address, and responsible person of firm or business subject to the disciplinary actions set forth in the preceding paragraph, name of medical devices, and circumstances of violation.

Article 57

In case the defective medical devices seized are domestically manufactured and may, after inspection or testing, still be usable through modification, the municipal or county (city) competent authority shall assign officials to supervise the original manufacturer in carrying out the modification within a time period. Those that cannot be modified or are not modified within the time period shall be confiscated and destroyed. Imported defective medical devices shall be immediately placed in confinement, and the municipal or county (city) competent authority shall order the original importer to return and export such devices within a time period. Those which are not returned within the time period shall be confiscated and destroyed.
In case any defective medical device set forth in Subparagraph 6 of Article 8 is seized, the municipal or county (city) competent authority shall order the medical device firm that manufactures or imports the device to correct its quality management system within a time period according to the severity of its circumstances.
The provisions of Paragraph 1 shall apply mutatis mutandis to medical devices that have been determined to be manufactured or imported without registration and market approval or listing.

Article 58

If any of the following circumstances is found to apply to any medical device, the medical device manufacturing or importing firm shall immediately notify medical institutions, other medical device firms, and pharmacies, and shall recall and handle marketed and stocked products within the specified time period:
1. Where a license has been obtained or listing has been completed, but its manufacture or import is prohibited by announcement.
2. Where the medical device is defective or has not been registered and approved or listed.
3. Where the finding after inspection, testing, or other risk assessment is that there is likelihood to cause harm to the health of human body for users.
4. Where the medical device manufacturing license has been cancelled by the central competent authority, or the medical device is manufactured or imported during the period when the medical device manufacturing license is not valid.
5. Where the manufacture or import of medical devices violates the provisions of Articles 26, 32, or 33.
6. Other circumstances in which a necessary recall is announced by the central competent authority.
When the medical device manufacturing or importing firm recalls medical device of the preceding paragraph, medical institutions, other medical device firms, and pharmacies shall give their cooperation.
Regulations governing the classification, approaches for recall operation, handling methods, and other matters to be complied with in regard to medical devices required to be recalled of Paragraph 1, shall be established by the central competent authority.

Article 59

The competent authority shall not only strictly keep confidential the identity information of those reporting defective medical devices that have been seized or medical devices that have not been registered and approved or listed, but also provide them incentives at its discretion.

Chapter VIII Penal Provisions

Article 60

Any person who manufactures or imports the defective medical devices set forth in Subparagraph 1 of Article 8 shall be subject to imprisonment for not more than five years, detention, or in addition thereto a fine of not more than NT$50,000,000.
Any person who knowingly sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the defective medical devices set forth in the preceding paragraph shall be subject to imprisonment for not more than three years, detention, or in addition thereto a fine of not more than NT$10,000,000.
Any person who commits the aforementioned offence set forth in Paragraph 1 by negligence shall be subject to imprisonment for not more than three years, detention, or in addition thereto a fine of not more than NT$10,000,000.
Any person who commits the aforementioned offence set forth in Paragraph 2 by negligence shall be subject to detention or a fine of not more than NT$1,000,000.

Article 61

Any person who uses, without authorization or as an infringement, the name, instructions, or labels of another legal medical device shall be subject to imprisonment for not more than five years, detention, or in addition thereto a fine of not more than NT$20,000,000.
Any person who knowingly imports, sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the medical devices set forth in the preceding paragraph shall be subject to imprisonment for not more than two years, detention, or in addition thereto a fine of not more than NT$10,000,000.

Article 62

Any person who violates Paragraph 1 of Article 25 and manufactures or imports medical devices without approval, or who violates Paragraph 2 of Article 25 and applies for listing instead of the required registration and market approval shall be subject to imprisonment for not more than three years, detention, or in addition thereto a fine of not more than NT$10,000,000.
This shall also apply to any person who knowingly sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the medical devices set forth in the preceding paragraph.

Article 63

In the event that the representative of a legal entity, or an agent, employee, or any other personnel of a legal entity or a natural person commits any of the offences set forth in Article 60 through the preceding article while performing his/her duty, the offender shall be punished in accordance with the provisions of all of the articles. Moreover, the said legal entity or natural person shall also be subject to up to ten times of the fine as set forth in all of the articles.

Article 64

Any person who manufactures or imports the defective medical devices set forth in Subparagraphs 2 through 5 of Article 8 shall be subject to a fine of not less than NT$60,000 but not more than NT$50,000,000.
Any person who sells, supplies, transports, stores, engages in brokerage of, transfers, or displays with the intent to sell the defective medical devices set forth in the preceding paragraph shall be subject to a fine of not less than NT$30,000 but not more than NT$20,000,000.

Article 65

Any person violating the provisions of Article 46 and labeling or promoting non-medical devices as having therapeutic effects shall be subject to a fine of not less than NT$600,000 but not more than NT$25,000,000.
A fine of not less than NT$200,000 but not more than NT$5,000,000 shall be imposed when any of the following circumstances occurs:
1. Violating the provisions of Article 40 and engaging in advertising of medical devices without being a medical device firm.
2. Violating the provisions of Paragraph 1 of Article 41 and failing to apply for approval or forward approval documents to mass media enterprises for verification before publishing or broadcasting a medical device advertisement.
3. Violating the provisions of Paragraph 2 of Article 41 and modifying or altering the originally approved contents of a medical device advertisement without approval.
4. Violating the restrictions on the extent of publishing or broadcasting medical device advertisements specified in Article 44.
5. Where medical devices are advertised in any of the manners set forth in the provisions of Article 45.
6. Where a medical device firm fails to give a notice or recall medical devices within the specified time period under any of the circumstances set forth in Subparagraphs 1 through 3 of Paragraph 1 of Article 58.

Article 66

Any mass media enterprise which violates the provisions of Paragraph 1 of Article 42 governing the publishing or broadcasting of advertisements shall be subject to a fine of not less than NT$200,000 but not more than NT$5,000,000, and shall be ordered to stop publishing or broadcasting the advertisements. For those who fail to stop publishing or broadcasting, a consecutive sentence shall be imposed for each violation until the said advertisements are no longer published or broadcast.
Any mass media enterprise which violates the provisions of Paragraph 2 of Article 42 and fails to preserve the information of the firm that commissions the advertisement, or evades, impedes, or refuses any request by the competent authority for such materials shall be subject to a fine of not less than NT$60,000 but not more than NT$300,000. A consecutive sentence shall also be imposed for each violation.
When imposing the disciplinary actions set forth in Paragraph 1, the municipal or county (city) competent authority shall notify the local competent authority or the competent authority of the target business for handling in accordance with applicable regulations.

Article 67

In the case of violation of the provisions of Chapter V of this Act, punishments shall be imposed in accordance with the provisions of this chapter, and the name of the offender, name of the medical device, and circumstances of committing the violation may be announced. In addition, the following disciplinary actions shall be imposed according to the severity of the violation:
1. Cancelling the medical device license or listing, and forbidding applications to use the original product name for a period of two years.
2. Ordering the offender to publish or broadcast corrected advertisements or commercials containing an apology and excluding wrong messages in the same size and time slots in the original publications or on the original channels for a certain number of times within 30 days upon receipt of the notification of punishment. Any business that fails to publish or broadcast corrected advertisements or commercials shall be subject to a fine of not less than NT$120,000 but not more than NT$600,000. Moreover, the approval that the business has obtained for all of the medical device advertisements shall be cancelled, and no advertisement applications shall be accepted within two years.
In the case of repeated violation after a punishment is imposed in accordance with the preceding paragraph, an order may be issued to terminate the business of the offender and cancel its company, business, or factory registration or part of the registered particulars.

Article 68

A fine of not less than NT$60,000 but not more than NT$2,000,000 shall be imposed when any of the following circumstances occurs:
1. Violating the provisions of Article 17 by purchasing or renting medical devices that have not been registered and approved or listed, or medical devices supplied by those other than medical device firms.
2. Violating the provisions of Paragraph 1 of Article 20 by failing to meet the Establishment Standards for Medical Device Manufacturers.
3. Where domestic medical device manufacturers violating the provisions of Paragraph 1 of Article 22 by failing to comply with the medical device quality management system regulations, or violating the provisions of Paragraph 2 of Article 22 by manufacturing medical devices without obtaining manufacturing license.
4. Where medical device dealers importing medical devices that have been manufactured in violation of the provisions of Paragraph 3 of Article 22 as applied mutatis mutandis pursuant to Paragraph 1 or Paragraph 2.
5. Violating the provisions of Paragraph 1 of Article 25 by manufacturing or importing medical devices without applying for registration and market approval or listing, or violating the provisions of Paragraph 2 of Article 25 by applying for listing instead of the required registration and market approval.
6. Violating the provisions of Paragraph 3 of Article 34 by selling domestically the medical devices that are for export only.
When the circumstances set forth in Subparagraph 3 or 4 of the preceding paragraph occur, in addition to the punishments that shall be imposed in accordance with the preceding paragraph, the central competent authority may publicize the names of the medical device firms and order them to make corrections within a time period, during which their manufacture, import, and business operations may be suspended in part or in whole. If no corrections are made within the time period, extension of medical device license in accordance with Article 27 shall not be approved or annual declaration in accordance with Article 28 shall not be filed, and any new applications for registration and market approval or listing of other medical devices of the manufacturers shall not be accepted. In the case of serious violation, the central competent authority may also cancel all or part of the medical device manufacturing licenses, licenses, or listings.

Article 69

In case a medical device firm uses false documents or information to file applications in accordance with the provisions of this Act, a fine of not less than NT$60,000 but not more than NT$2,000,000 shall be imposed. In the case of serious violation, no application shall be allowed within two years. The licenses or approvals that have been obtained shall be cancelled.

Article 70

A fine of not less than NT$30,000 but not more than NT$1,000,000 shall be imposed when any of the following circumstances occurs:
1. Violating the provisions of Paragraph 1 of Article 13 by engaging in the business activities of medical device firms without being a medical device firm, or violating the provisions of Paragraph 2 of Article 13 by failing to complete change registration for any change in the particulars registered.
2. Violating the provisions of Paragraph 3 of Article 13 by failing to complete medical device firm registration or failing to manufacture, sell, or supply medical devices at the registered place.
3. Violating the limitations announced in accordance with Article 18.
4. Violating the provisions of the regulations established in accordance with Paragraph 4 of Article 22 in regard to alteration.
5. Violating the provisions of Paragraph 1 of Article 23 by authorizing the commissioning or accepting the commissioning to manufacture medical devices without approval, or violating the provisions of Paragraph 2 of Article 23 by manufacturing medical devices.
6. Violating the provisions of Paragraph 1 of Article 24 by failing to comply with the regulations for good distribution practice of medical devices, or violating the provisions of Paragraph 2 of Article 24 by engaging in wholesale, import, or export of medical devices without obtaining a distribution license.
7. Violating the provisions of Paragraph 1 of Article 25 by selling, supplying, transporting, storing, engaging in brokerage of, transferring, or displaying with the intent to sell medical devices without applying for registration and market approval or listing.
8. Violating the provisions of Article 26 by making alteration to any of the original particulars of registration and market approval or listing without approval.
9. Violating the provisions of Article 32 or 33 in regard to the packaging, labels, and instructions of medical devices or the particulars indicated thereof.
10. Violating the provisions of the regulations established in accordance with Paragraph 2 of Article 35 in regard to restrictions on supply and sale or return.
11. Violating the provisions of Paragraph 1 of Article 37 by implementing a clinical trial without approval, or violating the provisions of Paragraph 2 of Article 37 by failing to obtain consent from human subjects prior to implementing the clinical trial.
12. Violating the provisions of Paragraph 1 of Article 48 by failing to report to the central competent authority, or violating the provisions of Paragraph 2 of Article 48 in regard to the conditions, reporting methods, time period, and contents.
13. Violating the provisions of Article 51 by evading, impeding, or refusing an inspection or random testing.
When the circumstances set forth in Subparagraph 6 of the preceding paragraph occur, in addition to the punishments that shall be imposed in accordance with the preceding paragraph, the central competent authority may publicize the names of the medical device firms and order them to make corrections within a time period, during which their wholesale, retail, import, and export may be suspended in part or in whole. For those who fail to make corrections within the time period, a consecutive sentence may be imposed for each violation until the corrections are made.

Article 71

A fine of not less than NT$20,000 but not more than NT$500,000 shall be imposed when any of the following circumstances occurs:
1. Where a medical device firm manufactures or imports the defective medical devices set forth in Subparagraph 6 of Article 8 and commits a serious violation, or fails to make corrections within the time period that has been ordered by the competent authority in accordance with Paragraph 2 of Article 57.
2. Violating the provisions of Paragraph 1 of Article 15 by failing to employ qualified technicians.
3. Violating the provisions of Paragraph 1 or 2 of Article 19, or violating the provisions of the regulations established in accordance with Paragraph 3 of Article 19 in regard to the scope, methods for establishment and maintenance of data, retention period, report contents and methods.
4. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 24 in regard to alteration.
5. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 37 in regard to avoidance of conflicts of interest, information disclosure, supervision and administration, or inspection, or failing to make corrections within the time period that has been ordered by the competent authority in accordance with the provisions of the said regulations.
6. Violating the provisions of Article 38 by failing to report or report for recordation, or failing to report or report for recordation within a time period.
7. Violating the provisions of Article 49 by failing to conduct reporting or undertake corrective and preventive measures in accordance with the provisions.
8. Violating the provisions of Article 53 by evading, impeding, or refusing a census.
9. Violating the provisions of Paragraph 3 of Article 55 by failing to withdraw or suspend the manufacture, import, or sale.
10. Failing to give recall notices or recall medical devices within a specified time period when any of the circumstances set forth in Subparagraphs 4 through 6 of Paragraph 1 of Article 58 occurs.
11. Violating the provisions of Paragraph 2 of Article 58 by failing to cooperate in recalling medical devices.
12. Violating the provisions of the regulations established in accordance with Paragraph 3 of Article 58 in regard to the approaches for recall operation and handling methods of medical devices.

Article 72

In case a person fined under this Act disagrees with the fine imposed in accordance with the provisions of this Act, he/she may, within fifteen days upon the receipt of the punishment notice, file a written objection requesting a review. However, no more than one objection shall be filed.
The authority imposing the fine shall, within fifteen days upon receipt of the written objection set forth in the preceding paragraph, review the case, and shall alter or cancel the original punishment if it deems the objection justifiable.
If the person fined disagrees with the result of the review set forth in the preceding paragraph, he/she may file an administrative appeal and initiate an administrative proceeding in accordance with applicable laws.

Article 73

In the event that approval is not given to the application for medical device clinical trial implementation, medical device registration and market approval, or change or extension of a license filed in accordance with this Act, the disagreeing applicant may, within four months upon receipt of the notice of disciplinary action, clearly state the reasons and apply for re-examination. However, only one application for re-examination is allowed.
The central competent authority shall alter or cancel the original disciplinary action if it deems that the application for re-examination set forth in the preceding paragraph is justifiable.
If the person applying for re-examination does not agree with the decision made regarding the re-examination, he/she may file an administrative appeal and initiate an administrative proceeding in accordance with applicable laws.

Article 74

Unless otherwise provided, the punishments prescribed in this Act shall be imposed by the municipal or county (city) competent authority, or may be imposed by the central competent authority if necessary. However, the cancellation of the company registration, business registration, factory registration, or the registered particulars, in part or in whole, upon confirmation of the order of business termination by the municipal or county (city) competent authority, shall be forwarded for execution by the industry or commerce competent authority or its competent authority of the target business.

Chapter IX Supplementary Provisions

Article 75

The enforcing authority may collect the necessary fees incurred by confiscation and destruction under this Act from offenders.

Article 76

Fees shall be paid when a person applies for or declares permits, licenses, or other matters in accordance with this Act, or makes formal inquiry about product registration and market approval, listing, annual declaration, and relevant regulations of medical devices.
Standards for the type and amount of the fees required in the preceding paragraph shall be determined by the central competent authority.

Article 77

When necessary, the competent authority at any level may designate a subordinate agency or commission a relevant agency (or institution), legal entity, organization, or private institution to conduct all or part of the testing of medical devices. Regulations governing its designation, commissioning, and related matters thereof shall be established by the central competent authority.

Article 78

The central competent authority may carry out accreditation of the relevant agency (or institution), legal entity, organization, or private institution commissioned to conduct testing, as set forth in the preceding article. Regulations governing their accreditation and management shall be established by the central competent authority.
The central competent authority may designate a subordinate agency or commission another agency (or institution), legal entity, organization, or private institution to carry out the accreditation work as set forth in the preceding paragraph. Regulations governing its designation, commissioning, and related matters thereof shall be established by the central competent authority.

Article 79

The central competent authority may designate a subordinate agency (or institution) or commission another agency (or institution), or an accredited legal entity or organization to carry out education and training of technicians, review of registration and market approval of medical devices, issuance of certificates, review and inspection of clinical trials, review of advertisements, reporting of serious adverse events, and inspection or census of medical device firms.
With the exception of education and training, the commissioned agency shall observe avoidance of conflicts of interest for matters related to designation or commissioning set forth in the preceding paragraph. Regulations governing its commissioning, accreditation, avoidance of conflicts of interest, and other related matters shall be established by the central competent authority.
The central competent authority may designate a subordinate agency or commission another agency (or institution) to carry out the accreditation work as set forth in Paragraph 1. Regulations governing its designation, commissioning, and related matters shall be established by the central competent authority.

Article 80

The central competent authority and central industry competent authority may provide incentives for research and development of innovative medical device technologies.
Regulations governing the eligibility criteria, review procedures of the incentives referred to in the preceding paragraph, and other related matters may be jointly established by the central competent authority and central industry competent authority.

Article 81

Due to the characteristics for use of medical devices, when research institutions, medical institutions, or medical device firms collect, process, or use personal data in accordance with Subparagraph 6 of Paragraph 1 of Article 6 of the Personal Data Protection Act, the central competent authority may announce other methods of consent equivalent to the written consent.

Article 82

In the event of violating the provisions set forth in Paragraph 1 or 2 of Article 8 and consequently resulting in occurrence of damages arising from injury to the medical device end-user patients or consumers, medical device manufacturers or importers shall be liable for compensation. However, this shall not apply if the medical device manufacturers or importers have no negligence in regard to the manufacturing, packaging, labeling, sterilization, or final inspection and release of the medical devices, or the injury is not caused by the negligence, or has exercised reasonable care to prevent such injury from occurring.
Even if the medical device end-user patients or consumers under the circumstances of the preceding paragraph have suffered an injury that is a non-pecuniary damage, they may claim for a reasonable amount of monetary compensation.
For claims filed by the medical device end-user patients or consumers set forth in the preceding two paragraphs, provisions of Articles 47 through 55 of the Consumer Protection Act may apply mutatis mutandis for initiation of consumer litigation.
Under the circumstances identified in Paragraph 1 or 2, if it is difficult or impossible for the medical device end-user patients or consumers to prove the monetary value of the actual damage, they may ask the court to award the compensation in the amount of at least NT$1,000 per incident, per person based on the severity of the damage.
In the event that the municipal governments or the county/city governments receive multiple claims from 20 or more medical device end-user patients or consumers due to the same incident, they shall assist medical device end-user patients or consumers to bring litigation in accordance with the provisions of Article 50 of the Consumer Protection Act.

Article 83

Starting from the effective date of this Act, the provisions of this Act shall apply to the management of medical devices, and the provisions of the Pharmaceutical Affairs Act governing medical devices shall no longer be applicable.

Article 84

The Enforcement Rules of this Act shall be established by the central competent authority.

Article 85

The date for enforcing this Act shall be determined by the Executive Yuan.

State Council Ordinance 739 in 2021

Mon, 01 Jan 2024 18:23:00 GMT

Regulations on the Supervision and Administration of Medical Devices

original regulation in Chinese

The chinese version shall still prevail in actuality.

Medical Device Management Act is coming in a few years. Contact us for original or english draft!

Historic

2024-09 Draft of People's Republic of China Medical Device Management Act

Impact : the law is getting in details and will have the same power as MDR in EU and higer than "Regulations on the Supervision and Administration of Medical Devices"

Analysis and speculation:

-The law takes some years till final version

-11 chapter and 190 articles

-new chapters: chapter 3 R&D, chapter 6 import and export, chapter 7 usage

-Strength of responsibility of legal representative (=chinese agent)

-Legal representative will be stricter qualified by having manufacturing or distribution licence

-Switch of medical device registration certificate possible

-Accelerate of review of clinical study and preference of multi-centre clinical trial

Tags : Regulations on the Supervision and Administration of Medical Devices, State Council Ordinance 739 in 2021 (former Ordinance 760), China Food and Drug Administration (CFDA, now National Medical Products Administration, NMPA), change registration, marketing authorization holder, MAH, registration and filling of medical device, Unique Device Identifier , overseas manufacturer, outsourced manufacturing enterprise in China , type testing , test report, clinical evaluation , instruction for use, labels , Medical Device Registration Certificates , adverse event, recall

Chapter 1 General Provisions

Chapter 2 Medical Device Product Registration and Filing

Chapter 3 Medical Device Production

Chapter 4 Operation and Use of Medical Devices

Chapter 5 Handling of Adverse Events and Recall of Medical Devices

Chapter 6 Supervision and Inspection

Chapter 7 Legal Liability

Chapter 8 Supplementary Provisions

Insight analysis!

Chapter 3 Medical Device Production

In China for produced medical device should be compliant to C hinese GMP

Chapter 4 Operation and Use of Medical Devices

See newest n otification of GSP in Chinese in 2023

Chapter 5 Handling of Adverse Events and Recall of Medical Devices

See explained Chinese vigilance process

Article 14 For the filing of Class I medical device ( see o ur article ), the following materials shall be submitted:

(1) Product risk analysis data;

(2) Product technical requirements ;

(3) Product testing report;

(4) Clinical evaluation data;

(5) User manual and label;

(6) Quality management system documents related to product development and production;

(7) Other materials required to prove product safety and effectiveness.

* (practise of us: type tesing of active product)

Application for Class II and Class III medical device ( see our article )

Article 21 The design, raw materials, production process, scope of application, method of use, etc. of registered II and III medical device have undergone substantial changes. If it is likely to affect the safety and effectiveness of the medical device, the registrants shall apply to the original registration department to go through the procedures for changing the registration; if other changes occur, it shall be filed or reported in accordance with the regulations of the drug regulatory department of the State Council.

See our detailed article of substantial changes

Our experte has published at Journal of Medical Device Regulation.

Ask us for original paper.

What is the impact of China’s new Order 739 on the medical device industry?

Abstract

A few days after implementation of Europe’s new Regulation on medical devices, China’s highest legislative Regulations on the Supervision and Administration of Medical Devices ( State Council Order 2021/739 ) came into force on 1 June 2021. With eight Chapters and 107 Articles, Order 739 has substantially changed the legislation for medical devices in China to support innovative products, enable use of self-testing reports, enhance post-market surveillance, and strengthen the penalties for non-compliance . Order 739 also sets out clear obligations for Marketing Authorisation Holders, and introduces new rules for adverse event reporting, Unique Device Identification, and electronic regulated product submissions. A comprehensive summary of Order 739 is presented by Dr Liang Li. Some supporting guidance documents and standards are eagerly awaited by stakeholders interested in the Chinese market so they can understand the full extent of the requirements for medical devices. China’s new requirements align the country more closely with regulatory requirements recommended by the International Medical Device Regulators Forum, as well as the regulatory systems in the USA and Europe. China remains one of the most regulatory challenging countries but at the same time it is one of the most important markets for medical device manufacturers.

Do you want to explore more insights of topics behind state council order 739, to master Chinese registration and to increase regulatory soft skills ?

Visit our E-Learning any time. We start firstly a face to face online meeting which is one unique character even during E-Learning.

Chapter 1 General Provisions

Article 1 In order to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry, these regulations are formulated.

Article 2 These Regulations shall apply to the activities of research, development, production, operation, use and supervision of medical devices within the territory of the People's Republic of China.

Article 3 The drug regulatory department of the State Council is responsible for the supervision and management of medical devices nationwide.

The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective responsibilities.

Article 4 The local people's government at or above the county level shall strengthen the leadership of the medical device supervision and management work in its administrative area, organize and coordinate the medical device supervision and management work and emergency response work within the administrative area, and strengthen the construction of medical device supervision and management capabilities. Provide guarantee for the safety of medical device.

The departments responsible for drug supervision and management of local people's governments at or above the county level are responsible for the supervision and management of medical devices in their respective administrative regions. The relevant departments of the local people's governments at or above the county level are responsible for the supervision and management of medical devices within their respective responsibilities.

Article 5 The supervision and management of medical devices shall follow the principles of risk management, full-process management and control, scientific supervision, and social co-governance.

Article 6 The state implements classified management of medical devices according to the degree of risk.

The class I is a medical device with a low degree of risk, and the implementation of routine management can ensure its safety and effectiveness.

The class II is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.

The class III is medical devices that have higher risks and require special measures to strictly control and manage them to ensure their safety and effectiveness.

To evaluate the risk degree of a medical device, factors such as intended use, structural characteristics and use method of the medical device should be considered.

The State Council's drug regulatory authority is responsible for formulating the classification rules and classification catalogs of medical device, and according to the production, operation and use of medical devices, timely analyze and evaluate the risk changes of medical devices, and adjust the classification rules and classification catalogs. To formulate and adjust classification rules and classification catalogs , the opinions of medical device registrants, record holders, production and operation enterprises, user units, and industry organizations shall be fully listened to, and the practice of international medical device classification shall be referred to. The classification rules and classification catalogs of medical devices shall be published to the public.

Article 7 Medical device shall meet the mandatory national standards for medical devices; if there are no mandatory national standards, they shall meet the mandatory industry standard s for medical devices.

Article 8 The state formulates plans and policies for the medical device industry, incorporates medical device innovation into the development focus, prioritizes the review and approval of innovative medical devices, supports the clinical promotion and use of innovative medical devices, and promotes the high-quality development of the medical device industry. The drug regulatory department of the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry planning and guiding policies.

Article 9 The State shall improve the medical device innovation system, support the basic research and application research of medical devices, promote the promotion and application of new medical device technologies, and provide support in the areas of scientific and technological project approval, financing, credit, bidding and procurement, and medical insurance. Support enterprises to establish or jointly establish research and development institutions, encourage enterprises to cooperate with universities, scientific research institutes, medical institutions, etc. to carry out research and innovation of medical devices, strengthen intellectual property protection of medical devices, and improve independent innovation capabilities of medical devices.

Article 10 The state strengthens the construction of informatization of medical device supervision and management, improves the level of online government services, and facilitates the administrative licensing and filing of medical devices.

Article 11 The medical device industry organization shall strengthen industry self-discipline, promote the establishment of a credit system, supervise and urge enterprises to carry out production and operation activities in accordance with the law, and guide enterprises to be honest and trustworthy.

Article 12 Units and individuals that have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with relevant national regulations.

Chapter 2 Medical Device Product Registration and Filing

Article 13 The class I medical devices are subject to product filling, and the II and III class medical devices are subject to product registration .

Medical device registrants and record holders shall strengthen the quality management of the entire life cycle of medical devices, and shall be responsible for the safety and effectiveness of medical devices in the entire process of development, production, operation, and use.

Article 14 For the filing of Class I medical device and application for Class II and Class III medical device product, the following materials shall be submitted:

(1) Product risk analysis data;

(2) Product technical requirements ;

(3) Product testing report;

(4) Clinical evaluation data;

(5) User manual and label ;

(6) Quality management system documents related to product development and production;

(7) Other materials required to prove product safety and effectiveness.

The product testing report shall meet the requirements of the drug regulatory department of the State Council. It may be a self-testing report of the medical device registration applicant or filing person, or testing report issued by a qualified medical device inspection agency .

Those who meet the requirements of Article 24 of these regulations to be exempt from clinical evaluation may be exempt from submitting clinical evaluation materials.

Medical device registration applicants and record holders shall ensure that the materials submitted are legal, true, accurate, complete and traceable.

Article 15 For the filing of Class I medical device, the filing person shall submit the filing materials to the department in charge of drug supervision and management of the municipal people's government with districts.

For overseas manufacturers who export class I medical devices to the territory of China, their designated domestic legal person shall submit the record materials and certification documents from competent authority of the country (region) where the record holder is located to approve the sale of the medical device to the drug regulatory authority of the State Council. Innovative medical devices that have not been listed overseas may not be required to submit a certification document that the competent authority of the country (region) where the record holder is located allows the medical device to be sold on the market.

The filing person shall complete the filing after submitting the filing materials in compliance with the provisions of these regulations to the department responsible for drug supervision and administration. The department responsible for drug supervision and administration shall, within 5 working days from the date of receipt of the filing materials, announce the filing-related information to the public through the online government service platform of the drug supervision and administration department of the State Council.

If there are changes in the matters stated in the filing materials, the filing shall be changed to the original filing department.

Article 16 To apply for the registration of Class II medical device, the registration applicant shall submit the registration application materials to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. To apply for the registration of Class III medical device, the registration applicant shall submit the registration application materials to the drug regulatory authority of the State Council.

For overseas manufacturers who export Class II and Class III medical devices to the territory of China, the domestic legal person designated by them shall submit the registration application materials and certification documents to prove that the medical device is on the market from competent authority of the country (region) where the registration applicant is located, to the drug regulatory authority of the State Council. Innovative medical devices that are not listed overseas may not be required to submit documents that the competent authority of the country (region) where the registration applicant is located allows the medical device to be marketed.

The drug regulatory authority under the State Council shall make provisions on the procedures and requirements for medical device registration review, and strengthen the supervision and guidance of the drug regulatory authority of the people's government of provinces, autonomous regions, and municipalities directly under the Central Government.

Article 17 The drug regulatory authority that accepts registration applications shall review the safety and effectiveness of medical devices, as well as the registration applicant's ability to ensure the safety and effective quality management of medical devices.

The date of acceptance of the application for registration of the drug regulatory departments shall accept registration application within 3 working days to apply for registration information was transmitted within the technical review mechanism. The technical review agency shall, after completing the technical review, submit the review comments to the drug regulatory authority that accepts the registration application as the basis for review and approval.

When the drug regulatory department that accepts the registration application considers it necessary to verify the quality management system when organizing the technical review of the medical device, it shall organize the quality management system verification.

Article 18 Drug Administration accepted an application for registration shall, from the date of receipt of the reviews 20 working days to make a decision. For those that meet the conditions, the registration is approved and a medical device registration certificate is issued; for those that do not meet the conditions, the registration is not granted and the reasons are given in writing.

The drug regulatory department that accepts the registration application should be within 5 working days from the date of approval of the registration of the medical device. Through the online government service platform of the State Councils drug regulatory authority to publish registration-related information to the public.

Article 19 For medical devices that are urgently needed for the treatment of rare diseases, severely life-threatening diseases without effective treatment, and responding to public health incidents, the drug regulatory authority that accepts registration applications may make a conditional approval decision. Relevant matters are stated in the medical device registration certificate.

In the event of a particularly major public health emergency or other emergencies that seriously threaten public health, the health authority of the State Council shall make recommendations for emergency use of medical devices according to the needs of prevention and control of the incident. After the approval by the drug regulatory authority of the State Council, the Emergency use occurs within the scope and time limit.

Article 20 Registrants and record holders of medical device shall perform the following duties:

(1) Establish and adapt product quality management system and applies it effectively;

(2) Development of post-marketing studies and risk management plan and to ensure the effective implementation;

(3) Carry out adverse event monitoring and re-evaluation in accordance with the law;

(4) Establish and implement product traceability and recall system;

(5) Other obligations stipulated by the drug regulatory department of the State Council. The domestic legal person designated by overseas manufacturers shall assist the registrant and filing party in fulfilling the obligations stipulated in the preceding paragraph.

Article 21 The design, raw materials, production process, scope of application, method of use , etc. of registered II and III medical device have undergone substantial changes. If it is likely to affect the safety and effectiveness of the medical device, the registrants shall apply to the original registration department to go through the procedures for changing the registration; if other changes occur, it shall be filed or reported in accordance with the regulations of the drug regulatory department of the State Council.

Article 22 The validity period of the medical device registration certificate is 5 years . If the registration needs to be renewed after the expiration of the validity period, an application for renewal of the registration shall be submitted to the original registration department 6 months before the expiration of the validity period.

Except for the circumstances specified in the third paragraph of this article, the drug regulatory authority that receives an application for renewal shall make a decision to approve the renewal before the expiration of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed that the renewal is approved.

In any of the following circumstances, the registration shall not be renewed:

(1)An application for renewal of registration has not been filed within the prescribed time limit;

(2)The mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration cannot meet the new requirements;

(3)Conditionally approved medical devices fail to complete the items specified in the medical device registration certificate within the prescribed time limit.

Article 23 For new developed products which have not been included in the catalogs of medical device, the applicants may directly apply for product registration in accordance with the provisions of this ordinance relating to class III medical device product registration, you can also determine the product classification . After the drug regulatory department applies for classification confirmation, product registration or product filing in accordance with the provisions of these regulations could be applied.

For directly applying for the registration of class III medical device, the drug regulatory department of the State Council shall determine the classification according to the degree of risk, and include the registered medical devices in the classification catalog in a timely manner. Product classification confirmed, the drug regulatory department of the State Council shall accept the date of application 20 working days determine and inform the applicant of the categories of medical devices within.

Article 24 The registration and filing of medical device shall be subject to clinical evaluation ; however, if one of the following conditions is met, clinical evaluation may be exempted :

(1) The working mechanism is clear, the design is finalized, the production process is mature, and the same product has been marketed. The medical device has been in clinical use for many years without serious adverse event records, and does not change its routine use;

(2) Other medical devices that can prove the safety and effectiveness of the medical device through non-clinical evaluation.

The drug regulatory department of the State Council shall formulate guidelines for clinical evaluation of medical devices.

Article 25 The clinical evaluation of medical devices can be carried out according to the product characteristics, clinical risks, existing clinical data, etc., through clinical trials, or through analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices to prove the medical treatment. The equipment is safe and effective.

According to the regulations of the State Councils drug regulatory authority, when conducting clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the product safety and effectiveness of medical devices, clinical trials should be carried out.

Article 26 The clinical trials of medical devices shall be conducted in clinical trial institutions with corresponding conditions in accordance with the requirements of the quality management standards for medical device clinical trials, and shall be reported to the people’s government of the province, autonomous region, and municipality where the clinical trial sponsor is located. The drug supervision and administration department that accepts the clinical trial filing shall notify the drug supervision and administration department and the health authority at the same level where the clinical trial institution is located.

Medical device clinical trial institutions shall implement record management. The conditions that a medical device clinical trial institution should have, as well as the filing management measures and clinical trial quality management specifications, shall be formulated and promulgated by the drug regulatory authority of the State Council in conjunction with the health authority of the State Council.

The state supports medical institutions to carry out clinical trials, incorporates the evaluation of clinical trial conditions and capabilities into the level review of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.

Article 27 If the clinical trials of Class III medical devices have a higher risk to humans, they shall be approved by the drug regulatory department of the State Council. When examining and approving clinical trials, the drug regulatory authority of the State Council shall conduct a comprehensive analysis of the equipment and professionals of the institution that intends to undertake the clinical trials of medical devices, the risk level of the medical devices, the implementation plan of the clinical trials, and the comparative analysis report of clinical benefits and risks, etc. , And make a decision and notify the clinical trial sponsor within 60 working days from the date of acceptance of the application. Failure to notify within the time limit shall be deemed as consent. If a clinical trial is approved, it shall be notified to the drug regulatory department and the health authority of the people's government of the province, autonomous region, or municipality where the clinical trial institution is located.

The c atalog of the third category of medical devices with higher risks to humans in clinical trials shall be formulated, adjusted and published by the drug regulatory department of the State Council.

Article 28 To carry out clinical trials of medical devices, ethical reviews shall be conducted in accordance with regulations, the subjects shall be informed of the details of the purpose, use and possible risks of the trial, and written informed consent of the subjects shall be obtained; A person with civil capacity or a person with limited civil capacity shall obtain the written informed consent of his guardian in accordance with the law.

In carrying out clinical trials, no fees related to clinical trials shall be collected from subjects in any form.

Article 29 For medical devices that are undergoing clinical trials for the treatment of serious life-threatening diseases without effective treatments, medical observations may benefit patients. After ethical review and informed consent, they can be used for medical treatment. The device clinical trial institution is free for other patients with the same condition and its safety data can be used for medical device registration applications.

Chapter 3 Medical Device Production

Article 30 To engage in the production of medical devices, one shall meet the following conditions:

(1) Have the production site, environmental conditions, production equipment and professional technical personnel suitable for the medical devices produced;

(2) Have the medical devices capable of producing medical devices Institutions or full-time inspectors and inspection equipment that conduct quality inspections;

(3) Have a management system to ensure the quality of medical devices;

(4) Have after-sales service capabilities that are compatible with the manufactured medical devices;

(5) Comply with product development and production processes The requirements specified in the document.

Article 31 Those engaged in the production of Class I medical devices shall file with the department responsible for drug supervision and administration of the municipal peoples government at the districted level, and complete the filing after submitting the relevant materials that meet the conditions specified in Article 30 of these regulations. .

If the medical device record holder produces the I class medical device by himself, he may submit the relevant materials that meet the conditions specified in Article 30 of these Regulations at the time of product filing in accordance with Article 15 of these Regulations to complete the production record.

Article 32 Those engaged in the production of Class II and Class III medical devices shall apply to the drug regulatory authority of the local province, autonomous region, or municipality directly under the Central Government for a production license and submit relevant materials that meet the conditions specified in Article 30 of these Regulations. And the registration certificate of the medical device produced.

Production license application for acceptance of drug regulatory department shall review information on the application, verification as required by drug regulatory department of the State Council of Medical Devices regulate the production and quality management, and the date of acceptance of the application within 20 working days in the decision. For those that meet the prescribed conditions, the license is granted and a medical device production license is issued; for those that do not meet the prescribed conditions, the license is not granted and the reasons are stated in writing. The medical device production license is valid for 5 years . If the validity period expires and needs to be renewed, the renewal procedures shall be handled in accordance with the legal provisions of the relevant administrative license.　

Article 33 The medical device production quality management norms shall address matters that affect the safety and effectiveness of medical devices, such as the design and development of medical devices, production equipment conditions, raw material procurement, production process control, product release, and enterprise organization and staffing.

Article 34 The medical device registrant and record holder can produce medical devices on their own, or they can entrust enterprises that meet the requirements of these regulations and have corresponding conditions to produce medical devices.

In the case of entrusted production of medical devices, the medical device registrant and record holders shall be responsible for the quality of the entrusted production of medical devices, and strengthen the management of the production activities of the entrusted production enterprises to ensure that they are produced in accordance with statutory requirements. The medical device registrant and record holder shall sign a commission agreement with the entrusted manufacturing enterprise to clarify the rights, obligations and responsibilities of both parties. The entrusted production enterprise shall organize production in accordance with laws and regulations, medical device production quality management norms, mandatory standards, product technical requirements and entrusted agreements, be responsible for the production activities, and accept the supervision of the entrusting party.

Implantable medical devices with high risks shall not be commissioned for production, and the specific catalogue shall be formulated, adjusted and announced by the drug regulatory department of the State Council.

Article 35 Medical device registrants, record holders and entrusted manufacturers shall establish and improve a quality management system compatible with the medical devices produced and ensure their effective operation in accordance with the medical device production quality management regulations; strictly follow the registered or record. The technical requirements of the products are organized to ensure that the medical devices that leave the factory meet the mandatory standards and the technical requirements of the registered or filed products.

Medical device registrants, record holders and entrusted manufacturers shall conduct self-inspection on the operation of the quality management system on a regular basis, and submit annual self-testing reports in accordance with the regulations of the drug regulatory authority under the State Council.

Article 36 If the production conditions of medical devices change and no longer meet the requirements of the medical device quality management system, the medical device registrant, record holder and entrusted manufacturer shall immediately take corrective measures; if it may affect the safety and effectiveness of the medical device, The production activities shall be stopped immediately and a report shall be made to the original production license or production filing department.

Article 37 Medical devices should use generic names . The generic name shall comply with the medical device naming rules formulated by the drug regulatory authority under the State Council.

Article 38 The State shall implement the unique identification system of medical devices step by step according to the category of medical device to realize the traceability of medical devices. The specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with relevant departments of the State Council.

Article 39 Medical devices shall have instructions for use and labels . The contents of the instructions and labels shall be consistent with the relevant contents registered or filed to ensure authenticity and accuracy.

The instructions and labels of medical devices should indicate the following items:

(1) Product generic name, model, and specifications

(2) Name, address and contact information of the medical device registrant, record holder or entrusted manufacturer

(3) Production date, use period or expiration date

(4) Product performance, main structure and scope of application

(5) Taboos, precautions and other warnings or reminders

(6) Installation and use instructions or diagrams

(7) Maintenance methods, special transportation, storage conditions and methods

(8) Technical requirements and other content should be marked

The class II and III medical devices should also be marked with the number of the medical device registration certificate. Medical devices used by consumers themselves should also have special instructions for safe use.

Chapter 4 Operation and Use of Medical Devices

Article 40 To engage in medical device business activities, there shall be business premises and storage conditions commensurate with the business scale and business scope, as well as a quality management system and quality management agency or personnel commensurate with the medical devices being operated.

Article 41 For those engaged in the business of class II medical devices, the business enterprise shall file with the department responsible for drug supervision and administration of the municipal people's government at the districted level and submit relevant materials that meet the conditions specified in Article 40 of these regulations.

According to the regulations of the State Council's drug regulatory department, the II class medical devices whose product safety and effectiveness are not affected by the circulation process can be exempted from business filing.

Article 42 For those engaged in the business of Class III medical devices, the business enterprise shall apply for business license to the department of the people's government at the districted city level in charge of drug supervision and management and submit relevant materials that meet the conditions specified in Article 40 of these regulations.

Business license application accepts responsibility for the drug regulatory department shall review the application materials, if necessary, verification of the organization, and the date of acceptance of the application within 20 working days in the decision. For those that meet the prescribed conditions, a license is granted and a medical device business license is issued; for those that do not meet the prescribed conditions, the license is not granted and the reasons are stated in writing.

The medical device business license is valid for 5 years. If the validity period expires and needs to be renewed, the renewal procedures shall be handled in accordance with the legal provisions of the relevant administrative license.

Article 43 Medical Device Registration people, business people filing their registration, filing medical devices, without having to apply for the operating license or medical devices prepared text, but should meet the operating conditions of this Regulation.

Article 44 To engage in the business of medical devices, one shall establish and improve a quality management system compatible with the medical devices operated in accordance with the laws and regulations and the requirements of the medical device business quality management standards formulated by the drug regulatory department of the State Council and ensure its effective operation.

Article 45 Medical device business enterprises and user units shall purchase medical devices from legally qualified medical device registrants, record holders and production and business enterprises. When purchasing medical devices, the suppliers qualifications and medical device qualification certificates shall be checked, and a record system for purchasing inspection records shall be established. Business enterprises engaged in the wholesale business of Type II and Type III medical devices and the retail business of Type III medical devices shall also establish a sales record system.

Record items include:

(1) Name, model, specification, and quantity of the medical device

(2) Production batch number, use period or expiration date and sales date of the medical device

(3) Medical device registrant, record holder or commissioned manufacturer name;

(4) Supplier or the buyer's address and contact information;

(5) The relevant permit file number.

Purchase inspection records and sales records shall be true, accurate, complete and traceable, and shall be kept in accordance with the time limit prescribed by the drug regulatory department of the State Council. The state encourages the use of advanced technology to record.

Article 46 Anyone engaged in online sales of medical devices shall be a medical device registrant, record holder or medical device business enterprise. Operators engaged in online sales of medical devices shall inform the relevant information about online sales of medical devices to the department responsible for drug supervision and administration of the people’s government at the districted city level, and operate Class I medical devices and Article 41 of these Regulations. Except for the II class medical devices specified in paragraph 2.

Operators of e-commerce platforms that provide services for online transactions of medical devices shall perform real-name registration of operators of online medical devices, review their business licenses, filing conditions, and the registration and filing of medical device they operate, and manage their business operations. If an e-commerce platform operator discovers that the networked medical device operator has violated the provisions of these Regulations, it shall stop and immediately report to the medical device operator’s location of the districted municipal people’s government responsible for drug supervision and management; if serious violations are found, The provision of online trading platform services should be stopped immediately.

Article 47 The transportation and storage of medical devices shall meet the requirements of the medical device instructions and labelling; if there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of the medical devices.

Article 48 A medical device user unit shall have a storage place and conditions suitable for the variety and quantity of medical devices in use. The medical device user unit shall strengthen the technical training of the staff, and use the medical device in accordance with the requirements of the product manual and technical operation specifications.

The deployment of large-scale medical device by the medical device user unit shall comply with the large-scale medical device configuration plan formulated by the health authority of the State Council, meet its functional positioning and clinical service needs, and have corresponding technical conditions, supporting facilities, and professional technology with corresponding qualifications and capabilities. Personnel, and have been approved by the health authorities of the people’s government at or above the provincial level to obtain a license for large-scale medical device configuration

The measures for the management of large-scale medical device configuration shall be formulated by the competent health department of the State Council in conjunction with relevant departments of the State Council. The list of large-scale medical device is proposed by the competent health department of the State Council in consultation with relevant departments of the State Council, and implemented after being approved by the State Council.

Article 49 Medical device users shall dispose of reusable medical devices in accordance with the regulations on disinfection and management formulated by the competent health department of the State Council.

Disposable medical devices shall not be reused, and used ones shall be destroyed and recorded in accordance with relevant national regulations. The list of single-use medical devices shall be formulated, adjusted and published by the drug regulatory department of the State Council in conjunction with the competent health department of the State Council. The list of single-use medical devices should have sufficient evidence that cannot be reused. Medical devices that can be reused to ensure safety and effectiveness are not included in the list of single-use medical devices. For medical devices whose design, production process, disinfection and sterilization technology, etc. are improved after repeated use can be guaranteed to be safe and effective, a single-use medical device catalog should be adjusted to allow repeated use.

Article 50 For medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance, medical device users shall conduct inspection, inspection, calibration, maintenance, and maintenance in accordance with the requirements of the product manuals, and record them, and conduct analysis and evaluation in a timely manner. Ensure that medical devices are in good condition and guarantee the quality of use; for large medical devices with a long service life, use files should be established one by one to record their use, maintenance, transfer, actual use time and other matters. The record retention period shall not be less than 5 years after the expiration of the prescribed use period of the medical device.

Article 51 The medical device user unit shall properly keep the original materials of the purchased III class medical devices and ensure that the information is traceable.

When large-scale medical devices and implantable and interventional medical devices are used, information such as the name of the medical device, key technical parameters, and necessary information closely related to the quality and safety of use shall be recorded in relevant records such as medical records.

Article 52 If the medical device used is found to have potential safety hazards, the medical device user unit shall immediately stop using it, and notify the medical device registrant, record holder or other organization responsible for product quality to perform maintenance; after the maintenance, the safety of use cannot be achieved. Standard medical device must not be used any more.

Article 53 For in- vitro diagnostic reagents that do not have products of the same type on the market in China , qualified medical institutions may develop them on their own according to the clinical needs of their own units, and use them in their own units under the guidance of medical practitioners. The specific management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the competent health department of the State Council.

Article 54 The department responsible for drug supervision and management and the health authority shall, in accordance with their respective responsibilities, supervise and manage the quality of medical devices and the behavior of medical devices in use.

Article 55 Medical device operating enterprises and user units shall not operate or use medical devices that have not been registered or filed in accordance with the law, have no qualified certification documents, and have expired, expired, or eliminated.

Article 56 When medical device users transfer medical devices in use between medical device users, the transferor shall ensure that the transferred medical devices are safe and effective, and shall not transfer expired, invalid, obsolete or unqualified medical devices.

Article 57 The imported medical devices shall be medical devices that have been registered or filed in accordance with the provisions of Chapter 2 of these Regulations.

Imported medical devices should have Chinese instructions and Chinese labels . The instructions and labels should meet the requirements of these regulations and relevant mandatory standards, and the instructions should state the origin of the medical device and the name, address, and contact information of the domestic legal person designated by the overseas manufacturers. Chinese instructions, Chinese labels, or instructions or labels that do not comply with the provisions of this Article shall not be imported.

Medical institutions that urgently need to import a small amount of Class II and Class III medical devices due to clinical need may be imported with the approval of the State Councils drug regulatory authority or the peoples government of a province, autonomous region, or municipality authorized by the State Council. Imported medical devices should be used for specific medical purposes in designated medical institutions.

It is forbidden to import expired, expired, and obsolete medical devices that have been used.

Article 58 The entry-exit inspection and quarantine agency shall c onduct inspections on imported medical devices in accordance with the law; those that fail the inspection shall not be imported.

The drug regulatory department of the State Council shall promptly notify the national entry-exit inspection and quarantine department of the registration and filing of imported medical devices. The entry-exit inspection and quarantine agency where the import port is located shall promptly report the customs clearance status of imported medical devices to the department in charge of the drug supervision and management of the municipal people's government with districts.

Article 59 Enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region).

Article 60 The content of medical device advertisements shall be true and legal, and shall be subject to the medical device instructions registered or filed by the department responsible for drug supervision and administration, and shall not contain false, exaggerated, or misleading contents.

To publish medical device advertisements, the advertisement review agency designated by the people's government of the province, autonomous region, or municipality directly under the Central Government shall review the content of the advertisement and obtain the approval number of the medical device advertisement; it shall not be published without review.

The drug supervision and administration department of the people's government at or above the provincial level shall order the suspension of production, import, operation and use of medical devices, and during the suspension period, advertisements involving such medical devices shall not be published.

The examination measures for medical device advertisements shall be formulated by the market supervision and administration department of the State Council.

Chapter 5 Handling of Adverse Events and Recall of Medical Devices

Article 61 The State Council establishes a medical device adverse event monitoring system to collect, analyze, evaluate and control medical device adverse events in a timely manner.

Article 62 Medical device registrants and record holders shall establish a medical device adverse event monitoring system, be equipped with adverse event monitoring institutions and personnel suitable for their products, actively carry out adverse event monitoring for their products, and follow the guidelines of the drug regulatory authority under the State Council. According to the regulations, report investigation, analysis, evaluation, product risk control, etc. to the medical device adverse event monitoring technical agency.

Medical device manufacturers and users shall assist medical device registrants and record holders in monitoring the adverse events of the medical devices produced, operated or used; discovering medical device adverse events or suspicious adverse events shall comply with the regulations of the State Council’s drug regulatory authority , To report to the technical agency for medical device adverse event monitoring.

Other units and individuals who discover medical device adverse events or suspicious adverse events have the right to report to the department in charge of drug supervision and management or medical device adverse event monitoring technical institutions.

Article 63 The drug regulatory department of the State Council shall strengthen the construction of a medical device adverse event monitoring information network.

Medical device adverse event monitoring technical institutions should strengthen the monitoring of medical device adverse event information, and actively collect information on adverse events; if adverse events are discovered or received, they should be verified in a timely manner, and investigation, analysis, and evaluation should be carried out when necessary, and they should be reported to the responsible drug Supervision and management departments and health authorities report and put forward suggestions for handling.

Medical device adverse event monitoring technical institutions shall publish contact information to facilitate medical device registrants, record holders, production and operation enterprises, users, etc. to report medical device adverse events.

Article 64 The department responsible for drug supervision and administration shall promptly take control measures such as issuing warning information and ordering the suspension of production, import, operation and use based on the assessment results of adverse events of medical devices.

The drug supervision and administration department of the people's government at or above the provincial level shall, in conjunction with the health authorities at the same level and relevant departments, organize timely investigation and treatment of medical device adverse events that cause sudden, mass injuries or deaths, and organize strengthened monitoring of similar medical devices .

The department in charge of drug supervision and management shall promptly notify the health authority at the same level of the adverse event monitoring of the medical device user unit.

Article 65 Medical device registrants, record holders, manufacturing and operating enterprises, and user units shall cooperate with medical device adverse event monitoring technical institutions, drug supervision and management departments, and health authorities in the investigation of medical device adverse events.

Article 66 In any of the following circumstances, the medical device registrant and record holder shall take the initiative to carry out the re-evaluation of the medical device that has been marketed:

(1) According to the development of scientific research, there is a change in the understanding of the safety and effectiveness of the medical device;

(2) Medical device adverse event monitoring, evaluation results show that medical devices may be defective;

(3) Drug regulatory department of the State Council, under other circumstances.

The medical device registrant and record holder shall, based on the results of the re-evaluation, take corresponding control measures to improve the medical devices already on the market, and make registration changes or record changes in accordance with regulations. If the result of the re-evaluation shows that the safety and effectiveness of the medical device on the market cannot be guaranteed, the medical device registrant and record holder shall take the initiative to apply for cancellation of the medical device registration certificate or cancellation of the record; the medical device registrant or record holder has not applied for the cancellation or cancellation of the medical device registration certificate In case of filing, the medical device registration certificate shall be cancelled or the filing shall be cancelled by the department responsible for drug supervision and administration.

The drug supervision and administration department of the people's government at or above the provincial level shall conduct re-evaluation of medical devices that have been marketed based on the monitoring and evaluation of medical device adverse events. If the result of the re-evaluation shows that the safety and effectiveness of the medical device on the market cannot be guaranteed, the medical device registration certificate shall be cancelled or the filing shall be cancelled.

The department responsible for drug supervision and administration shall promptly announce the cancellation of the medical device registration certificate and the cancellation of the record to the public. Medical devices whose registration certificates for medical devices have been cancelled or whose filings have been cancelled shall not continue to be produced, imported, operated, or used.

Article 67 If the medical device registrant or record holder discovers that the medical device produced does not meet the mandatory standards, the technical requirements of the registered or filed product, or has other defects, it shall immediately stop production and notify the relevant operating enterprise and user unit Stop business and use with consumers, recall medical devices that have been on the market, take measures such as remediation and destruction, record relevant conditions, release relevant information, and report the recall and handling of medical devices to the department responsible for drug supervision and management and the health authority report.

If the entrusted production or operation enterprise of medical devices discovers that the production or operation of the medical device is under the conditions specified in the preceding paragraph, it shall immediately stop the production and operation, notify the medical device registrant and record holder, and record the suspension of production, operation and notification. The medical device registrant and record holder believe that the medical device that needs to be recalled in accordance with the provisions of the preceding paragraph shall be recalled immediately.

If the medical device registrant, record holder, entrusted manufacturing enterprise, or operating enterprise fails to implement the recall or stop production or operation in accordance with the provisions of this article, the department responsible for drug supervision and administration may order the recall or stop production or operation.

Chapter 6 Supervision and Inspection

Article 68 The State establishes a system of professional and specialized inspectors to strengthen the supervision and inspection of medical devices.

Article 69 The department responsible for drug supervision and management shall strengthen the supervision and inspection of the quality of medical devices in the development, production, operation and use of medical devices, and conduct key supervision and inspections on the following items:

(1) Whether it is in accordance with the registered or the technical requirements of the registered products are to organize production;

(2) Whether the quality management system maintains effective operation;

(3) Whether the production and operation conditions continue to meet the statutory requirements.

When necessary, the department responsible for drug supervision and administration may conduct extended inspections of other relevant units and individuals that provide products or services for medical device development, production, operation, and use.

Article 70 The department in charge of drug supervision and management has the following powers in supervision and inspection:

(1) Entering the site to conduct inspections and taking samples;

(2) Inquiring, copying, sealing up, and seizing relevant contracts, bills, account books and other relevant materials;

(3) Seal up and seize medical devices that do not meet statutory requirements, illegally used spare parts, raw materials, and tools and equipment used in the illegal production and operation of medical devices;

(4) Seal up places that violate the provisions of these regulations and engage in medical device production and operation activitie.

In conducting supervision and inspection, law enforcement certificates shall be presented to keep the business secrets of the entity under inspection.

Relevant units and individuals shall cooperate in supervision and inspection, provide relevant documents and materials, and shall not conceal, refuse, or obstruct.

Article 71 The competent health department shall strengthen supervision and inspection of the use of medical devices by medical institutions. When implementing supervision and inspection, you can enter a medical institution to consult and copy relevant files, records and other relevant materials.

Article 72 Where there are hidden product quality and safety hazards in the production and operation of medical devices, and if no timely measures are taken to eliminate them, the department responsible for drug supervision and administration may take measures such as warnings, responsibility interviews, and orders for rectification within a time limit.

For medical devices that cause harm to the human body or that there is evidence to prove that they may harm human health, the department responsible for drug supervision and administration may take emergency control measures that order the suspension of production, import, operation, and use, and issue safety warning information.

Article 73 The department responsible for drug supervision and administration shall strengthen the random inspection and inspection of medical devices produced, operated and used by medical device registrants, record holders, production and operation enterprises and users. Random inspections shall not charge inspection fees and any other expenses, and the required expenses shall be included in the budget of the government at the same level. The drug supervision and administration department of the people's government at or above the provincial level shall issue a medical device quality announcement in a timely manner based on the conclusions of random inspections.

The competent health department shall supervise and evaluate the use of large-scale medical device; if any illegal use and excessive inspection and over-treatment related to large-scale medical device are found, it shall be corrected immediately and dealt with in accordance with the law.

Article 74 If the department responsible for drug supervision and management fails to discover the systemic risks of medical device safety in time, and fails to eliminate the hidden dangers of medical device safety in the supervision and management area in time, the people's government at the same level or the department in charge of the drug supervision and management of the people's government at a higher level shall deal with it. The main person in charge conducts an interview.

Where the local people's government fails to perform its medical device safety responsibilities and fails to eliminate major regional medical device safety hazards in a timely manner, the higher-level people's government or the drug supervision and administration department of the higher-level people's government shall hold an interview with its main person in charge.

The department and the local people's government interviewed shall take immediate measures to rectify and reform the supervision and management of medical devices.

Article 75 The qualification accreditation of medical device inspection institutions shall be managed in a unified manner in accordance with relevant national regulations. Only the inspection agency recognized by the certification and accreditation supervision and management department of the State Council and the drug regulatory department of the State Council can carry out inspections on medical devices.

If the department in charge of drug supervision and administration needs to inspect medical devices in law enforcement work, it shall entrust a qualified medical device inspection agency to conduct the inspection and pay the relevant expenses.

If the parties have objections to the inspection conclusions, they may submit an application for re-inspection to the department that conducts sampling inspection or the department responsible for drug supervision and administration at the next higher level within 7 working days from the date of receipt of the inspection conclusion, and the department that accepts the re-inspection application The re-inspection agency is randomly selected in the list of re-inspection agencies to conduct re-inspection. The medical device inspection agency undertaking the re-inspection work shall make a re-inspection conclusion within the time specified by the drug regulatory authority under the State Council. The re-inspection conclusion is the final inspection conclusion. The re-inspection institution and the initial inspection institution shall not be the same institution; if there is only one qualified inspection institution for the relevant inspection items, the undertaking department or personnel shall be changed during the re-inspection. The list of re-inspection agencies shall be announced by the drug regulatory department of the State Council.

Article 76 For medical devices that may contain harmful substances or change the design, raw materials and production processes of medical devices without authorization and have hidden safety hazards, medical devices that cannot be inspected in accordance with the inspection items and inspection methods specified in the national standards and industry standards for medical devices The inspection agency may use the supplementary inspection items and inspection methods approved by the drug regulatory authority of the State Council to conduct inspections; the inspection conclusions drawn from the supplementary inspection items and inspection methods may be used as the basis for the quality of medical devices recognized by the drug regulatory authority.

Article 77 The market supervision and management department shall supervise and inspect medical device advertisements in accordance with relevant advertising management laws and administrative regulations, and investigate and deal with illegal acts.

Article 78 The department responsible for drug supervision and administration shall, through the online government service platform of the drug supervision and administration department of the State Council, promptly publish the daily supervision and management information of medical device licensing, filing, random inspection, investigation of illegal acts, etc. in accordance with the law. However, the commercial secrets of the parties concerned shall not be disclosed.

The department in charge of drug supervision and management establishes the credit files of medical device registrants, record holders, production and operation enterprises, and users, increases the frequency of supervision and inspection for those with bad credit records, and strengthens punishment for untrustworthiness according to law.

Article 79 The department responsible for drug supervision and administration and other departments shall publish the contact information of the unit, and accept consultation, complaint, and report. The department in charge of drug supervision and management and other departments shall respond in time when receiving inquiries related to the supervision and management of medical devices; when receiving complaints and reports, they shall verify, handle and respond in a timely manner. The consultations, complaints, and reports, as well as their responses, verifications, and handling, shall be recorded and kept.

If a report on medical device development, production, operation, and use is true after investigation, the department responsible for drug supervision and administration and other departments shall reward the reporter. Relevant departments shall keep the reporter confidential.

Article 80 The drug regulatory department of the State Council formulates, adjusts, and revises the catalogues and regulations related to the supervision and management of medical devices, and shall solicit public opinions; take the form of hearings, demonstration meetings, etc., to listen to experts and medical device registrants, The opinions of the filing person, production and operation enterprises, user units, consumers, industry associations and related organizations.

Chapter 7 Legal Liability

Article 81 Under any of the following circumstances, the department responsible for drug supervision and administration shall confiscate illegal income, illegal production and operation of medical devices, and tools, equipment, raw materials and other items used in illegal production and operation; illegal production and operation of medical devices value of the amount is less than 1 k, and impose a 50 k to 150 k yuan fine; the value of the amount of 10k yuan, and impose value of the amount 15 times more than 30 times the fine; the circumstances are serious, ordered to cease , Within 10 years, the relevant responsible persons and units will not accept medical device license applications, and the legal representatives, main responsible persons, directly responsible persons in charge and other responsible persons of the illegal units will be confiscated from the unit’s income during the occurrence of the illegal acts. , And impose a fine of more than 30% of income but not more than 3 times, and prohibit them from engaging in medical device production and operation activities for life:

(1) Production and operation of Class II and Class III medical devices that have not obtained a medical device registration certificate

(2) Engaging in the production activities of the second and third categories of medical devices without permission

(3) Engaging in the business activities of the third categories of medical devices without permission.

In the case of the first item of the preceding paragraph and the circumstances are serious, the original license-issuing department shall revoke the medical device production license or medical device business license.

Article 82 Anyone who disposes and uses large-scale medical device without permission shall be ordered by the health authority of the peoples government at or above the county level to stop the use, give a warning, and confiscate the illegal income; if the illegal income is less than 10k yuan, a penalty of more than 50k to 100 k yuan shall be imposed. the illegal gains 10k yuan or more yuan, and impose illegal income 10 times more than 30 times the fine; the circumstances are serious, 5 large medical device configuration permit application will not be accepted during the year related to liability and the units proposed for illegal The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% but not more than 3 times of the income, and shall be punished in accordance with the law.

Article 83 Where false information is provided or other deceptive methods are used when applying for an administrative license for medical devices, the administrative license shall not be granted. If the administrative license has been obtained, the administrative license shall be revoked by the department that made the administrative license decision, and the illegal income and illegal production shall be confiscated. For medical devices used in business, applications for medical device licenses submitted by relevant persons and units will not be accepted within 10 years; medical devices used in illegal production and operation with a value of less than 10,000 yuan will be fined between 50k yuan and 150k yuan; the value of the amount of 1 million yuan, and impose value of the amount 15 times more than 30 times the fine; executives circumstances are serious, ordered to cease, the legal representative of the illegal units, the main person in charge, directly in charge and other responsibilities Personnel, confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% of the income but not more than 3 times, and prohibit them from engaging in medical device production and operation activities for life.

Anyone who forges, alters, sells, rents, or lends relevant medical device licenses shall be confiscated or revoked by the original license-issuing department, and the illegal gains shall be confiscated; if the illegal gains are less than 10,000 yuan, a fine of 50k yuan up to 100k yuan shall be imposed. ; illegal income 10k yuan, and impose illegal income 10 times more than 20 times the fine;, shall constitute a violation of the security Administration punishment public security administration by the public security organs according to law.

Article 84 In any of the following circumstances, the department responsible for drug supervision and management shall announce the name of the unit and product to the public and order it to make corrections within a time limit; if the correction is not made within the time limit, the illegal income and medical devices produced and operated illegally shall be confiscated; illegal production and operation medical devices value of the amount is less than 1k, and impose 1k or above 5k fine; the amount of the value of 1 or more million yuan, impose a value of the amount 5 times more than 20 times the fine; the circumstances are serious, The legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 2 times the income . Prohibited within 5 years it is engaged in the production and operation of medical devices:

(1) Production and operation of the first-class medical devices that have not been registered

(2) The production of I class medical devices without the registration

(3) The operation of the II class medical devices without registration

(4) The files that have been filed do not meet the requirements

Article 85 If false information is provided during filing, the department responsible for drug supervision and management shall announce the name of the filing unit and product to the public, and confiscate illegal income and illegally produced and operated medical devices; the value of illegally produced and operated medical devices is less than 1k, and impose 20k to 50k fine; the value of the amount of 10k yuan or more, the value of the amount and impose a 5 times more than 20 times the fine; the circumstances are serious, ordered to cease, on illegal units The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income, and prohibit them from engaging in medical device for 10 years Production and business activities.

Article 86 In any of the following circumstances, the department responsible for drug supervision and administration shall order corrections and confiscate the medical devices used in illegal production and operation; if the value of the medical devices used in illegal production and operation is less than 10k yuan, they shall be punished 20k yuan to 50k yuan fine; the value of the amount of 1 million or more, the value of the amount and impose a 5 times more than 20 times the fine; the circumstances are serious, ordered to cease until the original issuing authority shall revoke the registration certificate of medical devices , Medical device production license, medical device business license, the legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income obtained from the unit during the period of the illegal act and the premises Receive a fine of more than 30% of income but not more than 3 times, and prohibit them from engaging in medical device production and operation activities within 10 years:

(1) The production, operation, and use of medical devices that do not meet mandatory standards or do not meet the technical requirements of registered or filed products

(2) Failure to organize production in accordance with the registered or filed product technical requirements, or failure to establish a quality management system and maintain effective operation in accordance with the provisions of these regulations, which affects product safety and effectiveness

(3) Operation and use without conformity certification documents, expired, or invalid, Obsolete medical devices, or use medical devices that have not been registered according to law

(4) Refusing to be recalled after being ordered by the department responsible for drug supervision and administration, or ordered to stop or suspend production, import, and operation by the department responsible for drug supervision and administration After that, it still refuses to stop the production, import, and operation of medical devices

(5) Entrusting enterprises that do not meet the requirements of these regulations to produce medical devices, or failing to manage the production activities of the entrusted manufacturing enterprises

(6) Import of expired, invalid or eliminated medical device

Article 87 Medical device operating enterprises and user units have fulfilled the obligations of purchase inspection and other obligations stipulated in these Regulations, and have sufficient evidence to prove that they do not know that the medical devices they operate and use are the first paragraph of Article 81 of the Regulations. If the medical devices under the conditions specified in paragraph 1 of Article 84, paragraph 1 of Article 86, and paragraph 3 of Article 86, and the source of their purchase can be truthfully stated, the medical devices that they operate and use that do not meet the statutory requirements shall be confiscated Devices can be exempted from administrative penalties.

Article 88 of the following circumstances shall be ordered by the drug regulatory department responsible for corrections and 10k or above 50k yuan fine; refuse to correct, at 50k to 100k yuan fine; circumstances In serious cases, it shall be ordered to suspend production and business until the original license-issuing department revokes the medical device production license and medical device business license. The legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated. During the period of the act, the income received from the unit, and the penalty is more than 30% or less than 2 times the income and it is prohibited from engaging in medical device production and operation activities within 5 years:

(1) The production conditions change and the medical device quality management system is no longer in compliance Requirement, failure to rectify, stop production, and report in accordance with these regulations

(2) Production and operation manuals and labels of medical devices that do not meet the requirements of these regulations

(3) Fail to transport and store medical devices in accordance with the requirements of medical device manuals and labelling

(4) Transfer of medical devices in use that have expired, expired, eliminated or failed inspections

Article 89 of the following circumstances, and in accordance with their respective responsibilities shall be ordered to correct by the department responsible for drug administration and health authorities, given a warning; refuse to correct, at 10k to 100 k yuan fine; serious cases If the company is involved, it shall be ordered to suspend production and business until the medical device registration certificate, medical device production license, and medical device business license are revoked by the original issuing authority, and the legal representative, main person in charge, directly responsible person in charge and other responsibilities of the illegal entity staff at the 1k or above 3k fine:

(1) Self-testing reports not submitted in accordance with the requirements of the quality management system

(2) Not have the legal qualification of the purchase of medical device

(3) Medical device enterprises or user has not established and implemented the medical device purchase inspection record system in accordance with the regulations

(4) Operating enterprises engaged in the second and third category medical device wholesale business and the third category medical device retail business have not established in accordance with the regulations and implement the sales record system

(5) Medical device registrants, record holders, production and operation enterprises, and user units fail to carry out medical device adverse event monitoring in accordance with the provisions of these regulations, fail to report adverse events in accordance with requirements, or monitor technology for medical device adverse events Adverse event investigations carried out by institutions, departments responsible for drug supervision and management, and health authorities will not cooperate

(6) Medical device registrants and record holders fail to formulate post-marketing research and risk control plans in accordance with regulations and ensure effective implementation

(7) Medical device registrants and record holders fail to establish and implement a product traceability system in accordance with regulations

(8) Medical device registrants, record holders, and operating companies engaged in online medical device sales fail to inform the department responsible for drug supervision and administration in accordance with regulations

(9) Medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance. The user of the medical device does not perform inspection, inspection, calibration, maintenance, maintenance and records in accordance with the requirements of the product manual, and analyzes and evaluates in time to ensure that the medical device is in good condition

(10) The use of medical device units are not properly preserved the original purchase of materials class III medical devices.

Article 90 For following circumstances shall a warning be given by the people's governments above the county level health authority: refuse to correct, at 50k to 100k yuan fine; circumstances are serious, at 10 k to 30k yuan or less, the relevant medical device use activities shall be suspended until the original license issuing department revokes the practice license, and the relevant responsible personnel shall be ordered to suspend the practice activities for more than 6 months and less than 1 year until the original license issuing department revokes the relevant activities. Personnel practice certificate, the legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income and give sanctions in accordance with the law:

(1) For reused medical devices, the medical device user fails to dispose of them in accordance with the disinfection and management regulations

(2) The medical device user reuses single-use medical devices or fails to destroy them in accordance with regulations used single-use medical devices

(3) The medical device user fails to record information on large medical devices and implantable and interventional medical devices in relevant records such as medical records in accordance with regulations

(4) The medical device user discovers that medical devices used have potential safety hazards. Users fail to notify for maintenance, or continue to use medical devices that cannot meet the safety standards after maintenance

(5) Medical device users use large-scale medical device in violation of regulations and cannot guarantee medical quality and safety

Article 91 Imported medical devices in violation of relevant laws and administrative regulations on the inspection of import and export commodities shall be dealt with in accordance with the law by the entry-exit inspection and quarantine agency.

Article 92 Operators of e-commerce platforms that provide services for medical device online transactions violate the provisions of these Regulations by failing to perform real-name registration of online medical device operators, review licensing, registration, and filing conditions, stop and report illegal acts, and stop Those who provide management obligations such as online trading platform services shall be punished by the department responsible for drug supervision and management in accordance with the provisions of the "E-commerce Law of the People's Republic of China".

Article 93 If a clinical trial is carried out without the registration of a medical device clinical trial institution, the department in charge of drug supervision and administration shall order it to stop the clinical trial and make corrections; if it refuses to make corrections, the clinical trial data shall not be used for product registration, filing, and processing. A fine of 50k yuan to 100k yuan shall be fined and an announcement shall be made to the public; if serious consequences are caused, it shall be prohibited from conducting clinical trials of related professional medical devices within 5 years, and a fine of 100k yuan but less than 300k yuan shall be imposed. The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% but not more than 3 times of the income, and shall be punished in accordance with the law.

If a clinical trial sponsor has carried out a clinical trial without filing, the department responsible for drug supervision and management shall order the suspension of the clinical trial, impose a fine of 50k yuan up to 100k yuan on the clinical trial sponsor, and make an announcement to the public; if serious consequences are caused, Impose a fine of 100k yuan up to 300k yuan. The clinical trial data shall not be used for product registration and filing, and medical device registration applications submitted by relevant responsible persons and units will not be accepted within 5 years.

If a clinical trial sponsor conducts a III class medical device clinical trial with a higher risk to the human body without approval, the department responsible for drug supervision and management shall order the immediate termination of the clinical trial and impose a penalty of 100kyuan to 300k yuan on the clinical trial sponsor The following fines shall be announced to the public; if serious consequences are caused, a fine of 300k yuan up to 1 million yuan shall be imposed. The clinical trial data shall not be used for product registration, and the clinical trial and registration applications for medical devices submitted by relevant responsible persons and units will not be accepted within 10 years. The legal representative, main responsible person, directly responsible person in charge and other responsible persons of the illegal unit will not be accepted. , Confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income.

Article 94 If a medical device clinical trial institution conducts a medical device clinical trial that fails to comply with the clinical trial quality management norms, the department in charge of drug supervision and management shall order it to make corrections or immediately stop the clinical trial, and impose a fine of 50k yuan up to 100k yuan; If serious consequences are caused, the relevant professional medical device clinical trials are prohibited within 5 years, and the health authority shall confiscate the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit during the period of the illegal act. The income earned by a unit and a fine of more than 30% and less than three times the income received shall be punished in accordance with the law.

Article 95 If a medical device clinical trial institution issues a false report, the department responsible for drug supervision and administration shall impose a fine of 100k yuan up to 300k yuan; if there is illegal income, the illegal income shall be confiscated; it shall be prohibited from conducting relevant professional medical treatment within 10 years Device clinical trials; the health authority shall confiscate the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit, and confiscate the income received from the unit during the period of the illegal act, and more than 30% of the income obtained from the premises Fines below 3 times shall be punished according to law.

Article 96 If a medical device inspection agency issues a false testing report, the competent authority granting the qualification will revoke the inspection qualification, and the relevant responsible persons and units will not accept the qualification accreditation application for 10 years, and impose a charge of 100k yuan or more and 300k yuan. The following fines; where there is illegal income, the illegal income shall be confiscated; the legal representative, the main responsible person, the directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income obtained from the unit during the period of the illegal act and dispose of the income obtained A fine of more than 30% of the income but less than 3 times shall be punished in accordance with the law; those who are expelled shall be prohibited from engaging in medical device inspection work for 10 years.

Article 97 Anyone who violates these regulations on the management of medical device advertising shall be punished in accordance with the provisions of the Advertising Law of the Peoples Republic of China.

Article 98 Where a domestic legal person designated by overseas manufacturers fail to perform relevant obligations in accordance with the provisions of these Regulations, the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government shall order correction, give a warning, and impose a 5 A fine of not less than 10k yuan but not more than 100k yuan; if the circumstances are serious, a fine of 100k yuan but not more than 500k yuan shall be imposed, and the legal representative, main person in charge, directly responsible person in charge and other responsible personnel shall be prohibited from engaging in the production and operation of medical devices within 5 years activity.

If overseas manufacturers refuse to implement the administrative penalty decision made in accordance with these regulations, the import of medical devices shall be prohibited for 10 years.

Article 99 If medical device research and development, production, and operation units and inspection institutions violate these regulations and use personnel who are prohibited from engaging in medical device production and operation activities or inspections, the department in charge of drug supervision and administration shall order corrections and give warnings; If it makes corrections, it shall be ordered to suspend production and business until the license is revoked.

Article 100 If a medical device technical review institution or a medical device adverse event monitoring technical institution fails to perform its duties in accordance with the provisions of these Regulations, causing major errors in the review and monitoring work, the department responsible for drug supervision and administration shall order corrections and report criticisms. A warning shall be given; if serious consequences are caused, the legal representative, the main responsible person, the directly responsible person in charge and other responsible persons of the illegal unit shall be punished according to law.

Article 101 If the staff of the department in charge of drug supervision and management or other relevant departments violates the provisions of these regulations, abuses their power, neglects their duties, or engages in malpractices for personal gain, they shall be punished in accordance with the law.

Article 102 Anyone who violates the provisions of these Regulations and constitutes a crime shall be investigated for criminal responsibility according to law; those who cause personal, property or other damage shall be liable for compensation according to law.

Chapter 8 Supplementary Provisions

Article 103 The meaning of the following terms in these Regulations:

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the necessary Computer software; its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is:

(1) Disease diagnosis and prevention, Monitoring, treatment or alleviation

(2) Diagnosis, monitoring, treatment, alleviation or functional compensation of injury

(3) Inspection, replacement, adjustment or support of physiological structure or physiological process

(4) Life support or maintenance

(5) Pregnancy control 　

(6) Provide information for medical or diagnostic purposes by examining samples from human bodies.

The medical device registrant and record holder refer to the enterprise or research institution that has obtained the medical device registration certificate or handled the record of medical device.

Medical device users refer to institutions that use medical devices to provide medical and other technical services to others, including medical institutions, family planning technical service institutions, blood stations, apheresis plasma stations, and rehabilitation assistive device adaptation institutions.

Large-scale medical device r efers to large-scale medical device with complex technology, large capital investment, high operating cost, large impact on medical expenses and included in catalog management.

Article 104 Fees may be charged for the registration of medical device. The specific charging items and standards shall be respectively formulated by the finance and price authorities of the State Council in accordance with relevant state regulations.

Article 105 The administrative measures for medical devices developed by medical and health institutions in response to public health emergencies shall be formulated by the drug regulatory authority of the State Council in conjunction with the competent health authority of the State Council.

The storage, allocation, and supply of non-profit contraceptive medical devices shall abide by the management measures formulated by the competent health department of the State Council in conjunction with the drug regulatory department of the State Council.

The technical guidelines for medical devices of Chinese medicine shall be formulated by the drug regulatory department of the State Council in conjunction with the traditional Chinese medicine regulatory department of the State Council.

Article 106 The supervision and management of the use of military medical devices shall be implemented in accordance with these Regulations and the relevant provisions of the military.

Article 107 The Ordinance comes into force since 01. 06. 2021 .

Do you want to have all applied Chinese regulation including guidance and standard in English ? You can select what suit your product.

We deliever in English translated Chinese regulation which was used by many prominent manufacturer of medical device.

Chinese IFU and Label

Sun, 31 Dec 2023 18:06:36 GMT

Life cycle of Chinese IFU and Label

Requirements on Chinese Instructions for use and label by NMPA

In accordance to Article 39 at “ Regulations on the Supervision and Administration of Medical Device s ” (Decree of the State Council No. 739, 2021) and “ Guidance of Instructions for use and labels of medical device ” (order 6, 2014), basic requirements on Instructions for use and label have to to be fulfilled in China. Compared to article 23, chapter III, annex 1 at MDR in EU , the requirements on Chinese Instructions for use and label are a kind thinned out and quite basic.

However, some items on Chinese Instructions for use and labels are often ignored and keep a potential finding by medical device authority NMPA in China. The reasons are diversified:

Sometimes the sources of translations of Chinese IFU and labels are different: internal marketing - and RA department, external translation office, local consulting company or own subsidiary in China and distributors in China.

Unfortunately it exists no controlling system of Chinese IFU by legal manufacturers consistently. Besides it, the registration process from dossier preparation to product approval takes almost 1.5 to 2 years for e.g. class II medical device . Actually there should be at least three revisions of Chinese IFUs in time manner, namely after type testing , after technical reviews by authority NMPA and after final issue of NMPA certificate .

Another close related topic is symbol. In China manufacturer should have the exact wording compliant to standard YY/T 0466.1: 2007 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements (draft in 2022).

What happens if the final IFU is inconsistent with the content on NMPA certificate after product approval?

In case there are inconsistent contents at Chinese IFU, labels with submission dossiers or NMPA certificate . You might have problem with distributors placing medical device in Chinese market, the hospital could refuse the medical device by controlling goods receipt even after signing the sales contract. In the worst scenario, NMPA finds this deficiency out and gives a penalty to legal manufacturers.

Before finding by NMPA it is so far not complicated to make a rapid application in term of change registration of IFU which dosen`t cost at NMPA and it take just some weeks, if legal manufacturer revises IFU without changing significant contents as intended use, key technical parameters etc.

L ife cycle of Chinese IFU

From plan of submission dossier to delivery of final IFU to client after product approval in China

We suggest that legal manufacturer uses only one resource of translation of Chinese IFU and labels with controlling system. As in workflow below (just IFU as an example), the life cycle of IFU starts from a draft of IFU . This is at the same time an input for product technical requirement (PTR) for type testing at which you have to submit IFU officially first time. Make sure that product name, variants/models and key technical parameters are at least consistent between IFU and PTR . Very often overseas manufacturers take care of draft of Chinese IFU. Chinese agent who is responsible for submission dossier, concentrates on PTR at basis of English IFU. The inconsistency happens not rarely.

After type testing the Chinese IFU might be revised if the technical parameters vary than given at PTR. Then it can occur that during technical review of submission dossier, some inconsistent contents, incorrect formulations and other performance claims are suggested by reviewers. In this case, the second revision of Chinese IFU is to follow.

At the end, NMPA will issue NMPA certificate with certification - and PTR number (the same) which should be added on final IFU . Meanwhile you should also leave revision date on final Chinese IFU.

Checklist of Chinese IFU and label

The checklist of IFU is derived from article 11 in guidance of Instructions for use and labels of medical device” (order 6, 2014).

Among label requirements in the table, these items are obligatory in Chinese if limited space on label , o therwise it is to mention in IFU:

See article 13 in guidance of Instructions for use and labels of medical device” (order 6, 2014):

Product name, model and variant
Name, address, contact info of legal manufacturer
Number of NMPA certificate and product technical requirement (PTR)
Manufacturing date and period of validity or expiration date

Special IFU requirements for electronic active device

There are also Chinese electronic standards series as IEC 60601. Special labelling requirements are to find in newest:

GB 9706.1-2020 (valid as of May, 2026, replacing GB 9706.1-2007)

Corresponding to IEC 60601-1:2012, edition 3, Medical electrical equipment—Part 1: General requirements for safety

YY 9706.102-2021 (valid as of May, 2026, replacing YY 0505-2012)

Corresponding to IEC 60601-1-2:2007, edition 3, Medical electrical equipment－Part 1-2: General requirements for safety－Collateral standards: Electromagnetic compatibility－Requirements and tests

Special IFU Requirements for standalone software

For additional IFU requirements it is wise to check general and product specific guidance. We list just some typical requirements:

Medical device software registration review guidelines

The instructions must reflect the software's functions, usage restrictions, input and output data types, necessary software and hardware, maximum number of concurrencies, interfaces, access control, operating environment (if applicable), performance efficiency (if applicable) and other information, and clarify the software release version……

Software of Artificial Intelligence Assisted Detection of Medical Devices

1. Conclusion of clinical trial

2. Scope of indication

3. Related requirements about data collection device and data collection process

4. If applicable: The software only assists doctors in detecting lesions, and there is the possibility of false negatives/positives. A professional physician should comprehensively give a final conclusion on lesion detection based on the patient’s medical history, symptoms, signs, and other examination results, and verify whether further diagnosis and treatment is needed. decision-making and be responsible for clinical diagnosis results

IFU Requirements for IVD (draft in 2022)

Product name
Packing specifications
Intended use
Principle of Inspection
Main components
Storage conditions and validity period
Applicable Instruments
Sample Requirements
Testing method
Positive judgment value or reference interval
Explanation of test results
Limitations of test methods
Product Performance Index
Precautions
Explanation of label
References
Basic Information
Medical Device Registration Certificate Number/Product Technical Requirement Number

or Medical Device Filing Number/Product Technical Requirement Number

19. Approval Date and Modification Date of IFU

Electronic IFU in China

There is no rule in term of eIFU. In a notification, Chinese authority has said only that eIFU should be consistent with approved IFU.

You might know the European regulation 2021/2226 and 207/2012. In China manufacturer could use eIFU in a wide product group independent of professional user or implant.

We can be your smart database of Chinese IFU. Contact us , we fulfil the highest technical demand plus your customer need with Chinese clients.

Summary

There is a continuous revision of Chinese IFU starting from first version, during product registration to final product approval. To prevent penalty due to non-conformity of Chinese IFU and label by NMPA, a controlling system in term of procedure on Chinese IFU and label in the whole life cycle should be established.

CONTACT US to have a template of requirements on Chinese IFU and label , exclusively in comparison to IFU requirements in article 23, chapter III, annex 1 at MDR .

Do you want to train your marketing colleague working on Chinese labelling without Chinese knowledge, visit our on-demand workshop.

Provisions for Instructions and Labels of Medical Devices

Mon, 30 Oct 2023 18:31:42 GMT

Provisions for Instructions and Labels of Medical Devices

Release time：2014-07-30

(Decree No.6 of China Food and Drug Administration)

The Provisions for Instructions and Labels of Medical Devices, adopted at the executive meeting of China Food and Drug Administration on June 27, 2014, is hereby promulgated and shall be effective as of October 1, 2014.

Provisions for Instructions and Labels of Medical Devices

Article 1 The Provisions is formulated according to the Regulations on Supervision and Administration of Medical Devices for the purpose of regulating instructions and labels of medical devices and ensuring safe use of medical devices.

Article 2 All medical devices sold or used within the territory of the People's Republic of China shall be accompanied by the instructions and labels in accordance with the requirements of the Provisions.

Article 3 Medical Device Instructions refers to those technical documents that are formulated by registrants or filing entities of medical devices, provided to users together with the products, covering their basic safety and effectiveness information, to guide the correct installation, testing, operation, use, repair and maintenance of products.

Medical Device Labels refers to the information in the forms of text, graphics and symbols that are printed or attached on medical devices or their packages, and are used for identifying product features and indicating safety warnings, etc.

Article 4 Contents in the instructions and labels of medical devices shall be scientific, authentic, complete, accurate, and shall be identical to product characteristics.

Contents in the instructions and labels of medical devices shall be consistent with the relevant information in their registration or filing.

Contents in medical device labels shall be consistent with those in medical device instructions.

Article 5 Descriptions of disease names, professional terms, processes and results of diagnosis and therapies in the instructions and labels of medical devices shall adopt nationally publicized or authorized terminology. Metrological units shall meet the requirements in corresponding national standards.

Article 6 Symbols or identification colors used in the instructions and labels of medical devices shall meet corresponding national standards. Where no such standards exist, the symbols and identification colors shall be described in the instructions.

Article 7 Instructions shall be attached to the minimal sale unit of medical devices.

Users of medical devices shall use medical devices following the instructions.

Article 8 Product names of medical devices shall adopt general names, which shall meet the rules of nomenclature of medical devices formulated by China Food and Drug Administration. Product names of class II and class III medical devices shall be consistent with the product names in the corresponding medical device registration certificates.

Product names of medical devices shall be clearly placed on prominent position of the instructions and labels.

Article 9 Text in the instructions and labels of medical devices shall be in Chinese, and the use of Chinese shall meet the national general rules for language and words. Other languages are optional in the instructions and labels of medical devices, but the Chinese version shall prevail.

Words, symbols, tables, figures and graphics in the instructions and labels of medical devices shall be accurate, clear and standardized.

Article 10 In general, the following content shall be included in medical device instructions:

(1) Name, model and specification of the product;
(2) Name, residence, contacts of registrant or filing entity and after-sales service agency. For import medical devices, name, address and contacts of the agent shall be also specified.
(3) Name, residence, manufacturing address, contacts and production license number or filing number of medical device manufacturer. For contract manufacturing, name, address, manufacturing address, production license number or filing number of contracted manufacturer shall be also specified.
(4) Registration certificate number or filing number of the medical device.
(5) Number of product technical requirements.
(6) Performance, main structure, composition or ingredients and scope of application of the product.
(7) Contraindications, precautions, warnings and suggestive descriptions.
(8) Installation and use instructions or illustrations; medical devices intended for personal use shall also be attached with special instructions for safe use.
(9) Product repair and maintenance methods, special conditions and methods for storage and transportation.
(10) Manufacturing/Production date, service life or expiry date.
(11) Accessories list, including accessories, appendants, and instructions for replacement interval and replacement methods of consumables.
(12) Description for graphics, symbols and abbreviations used in medical device labels.
(13) Compilation or revision date of the instructions.
(14) Other information which should be indicted.

Article 11 Precautions, warnings and indicative descriptions in medical device instructions mainly include:

(1) Use subject of the product.
(2) Potential safety hazards and use restriction.
(3) Protective measures for operators and users, and emergent and corrective measures that shall be taken, when accidents occur in proper use of the product.
(4) Necessary monitoring, evaluation, and control methods.
(5) A word “Single-use” or a symbol shall be marked for disposable products. For sterilized products, sterilization methods and handling means for the occasion when sterile package is broken shall be indicated. For product needs to be disinfected or sterilized before use, methods of disinfection or sterilization shall be specified.
(6) For a product needs to be installed or used in combination with other medical devices, requirements, use methods and precautions of the combining medical devices shall be provided.
(7) Interferences with other products and possible harm that may occur during the use of the products.
(8) Potential adverse events in the use of product, or ingredients or excipients existed in product composition that may introduce side effects.
(9) Precautions for medical device discarding or disposal. For products that need to be disposed after use, disposal methods shall be provided.
(10) Other issues, according to product features, that the operators or users shall be alerted of.

Article 12 For reusable medical devices, treatment processes, including methods of cleaning, disinfection, packaging and sterilization, as well as times of reuse and other restrictions, shall be provided in instructions.

Article 13 Generally, the following content shall be included in medical device labels:

(1) Name, model and specification of product.
(2) Name, address, contacts of registrant or filing entity, for import medical devices, name, address and contacts of the agent shall be also specified.
(3) Registration certificate number or filing number of the medical device.
(4) Name, residence, manufacturing address, contacts and production license number or filing number of medical device manufacturer. For contract manufacturing, name, address, manufacturing address, production license number or filing number of contracted manufacturer shall be also specified.
(5) Manufacturing/Production date, service life or expiry date.
(6) Conditions for power connection, and input power.
(7) Graphics, symbols and other relevant information, according to product features, that shall be marked.
(8) Necessary warnings and precautions.
(9) Conditions or explanations for special storage and operation.
(10) For a medical device causing hazard to or having negative effects on the environment, a warning symbol or a warning description in Chinese shall be included in the label.
(11) For medical devices that are radioactive or with radiation, a warning symbol or a warning description in Chinese shall be included in the label.

Where all the above-mentioned information may not be covered completely in the label due to the limits of its position or size, the label shall at least contain name, model, specifications, production date, service life or expiry date of the product, and a sentence of “Refer to instructions for other details” shall be clearly indicated in the label.

Article 14 Medical device instructions and labels shall not contain the following contents:

(1) Asserts or assurances indicating functions or effects, such as “best therapeutic effect”, “guaranteed cure”, “cure all”, “complete cure”, “immediate effect” and “completely free from toxicity or side-effect”, etc..
(2) Absolute expression or words, such as “the highest technology”, “the most scientific”, “the most advanced”, “the best”, etc..
(3) Claim of cure rate or effective rate.
(4) Comparisons of effectiveness and safety with products of other manufacturers.
(5) Promissory descriptions like “secured by insurance company” or “refund for no effect”.
(6) Using name or image of any entity or person for proof or recommendation.
(7) Misleading descriptions that make people feel they might have some diseases or misunderstand or they might get certain diseases or the diseases would be aggravated without using the medical devices, and other false, exaggerated and misleading information.
(8) Other contents forbidden by laws or regulations.

Article 15 Medical device instructions shall be submitted by registration applicant or filing entity to food and drug regulatory authorities for review or filing in application for medical device registration or filing. The submitted instructions shall be consistent with registration or filing documents.

Article 16 The instructions approved by food and drug regulatory authorities shall not be changed without authorization.

For registration changes to the registered medical device, registration applicant shall voluntarily modify the contents of the instructions and labels according to the change certificate obtained.

For changes of other contents of the instructions, registration applicant shall inform the registration department in writing, and comparison descriptions and relevant documents of changes shall be submitted. Instructions change takes effects, if the registration department does not send a formal notice of rejection within 20 working days from the date it is informed in writing by the registration applicant.

Article 17 For changes of the contents included in the filing information form, of the technical requirements of filed medical device, and for changes of other contents in the instructions, the filing entities shall modify the relevant contents of the instructions and labels by themselves.

Article 18 Where the instructions and labels fail to comply with the Provisions, punishment shall be imposed by the food and drug regulatory departments at or above county level according to stipulations of Article 67 of Regulations on Supervision and Administration of Medical Devices.

Article 19 The Provisions shall be effective as of October 1, 2014. The Provisions on the Administration of Instructions, Labels and Package Marks of Medical Devices promulgated on July 8, 2004 (Decree No.10 of the former Sate Food and Drug Administration) is annulled simultaneously.

Medical Device Registration and Filing Management Measurese, Nr. 47 in 2021

Sun, 17 Sep 2023 13:30:34 GMT

Administrative Measures for Medical Device Registration and Filing

Order No. 47 of the State Administration for Market Regulation in 2021

original regulation in Chinese

The chinese version shall still prevail in actuality.

T ags: Classification, Product technical requirement, Type testing , instruction for use and label , innovative products, QMS, imported Class II and Class III medical device, Clinical Evaluation , clinical trial, p roduct change , Product registration, Change registration, Renewal , technical review , medical device certificate

Chapter 1 General rules

Chapter 2 Basic requirements

Chapter 3 Registration of medical devices

Chapter 4 Product registration

Chapter 5 C hange of registration and renewal of registration

Chapter 6 Filing of medical devices

Chapter 7 Time frame for registration

Chapter 8 Supervision and management

Chapter 9 Legal liability

Chapter 10 Annexes

Chapter I. General rules

Article 1 In order to regulate the registration and filing of medical devices, to ensure the safety, effectiveness and quality control of medical devices , according to the "Regulations for the Supervision and Administration of Medical Devices", to develop these measures.

Article 2 in the People's Republic of China engaged in medical device registration, filing and its supervision and management activities, the application of these measures.

Article 3 medical device registration refers to the medical device registration applicant (hereinafter referred to as the applicant) in accordance with the statutory procedures and requirements of the application for registration of medical devices, drug supervision and management departments in accordance with laws and regulations, based on scientific knowledge, safety, effectiveness and quality control and other reviews, to decide whether to agree to its application activities.

Medical device filing refers to the medical device filer (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the drug regulatory authority to submit the record information, the drug regulatory authority to submit the record information filed for inspection activities.

Article 4 the State Drug Administration in charge of the national medical device registration and filing management, responsible for the establishment of medical device registration and filing management system and system, according to the organization of the third class and the import of Class II, Class III medical device review and approval, the import of Class I medical devices for the record and related supervision and management, the local medical device registration and filing supervision and guidance.

Article 5 of the State Drug Administration Medical Device Technical Review Center (hereinafter referred to as the State Bureau of Device Review Center) is responsible for the clinical trial approval of medical device clinical trial applications and domestic Class III and imported Class II and Class III medical device product registration applications, change of registration applications, renewal of registration applications and other technical review work.

State Drug Administration Medical Device Standards Management Center, China Institute of Food and Drug Testing, State Drug Administration Food and Drug Administration Food and Drug Audit and Inspection Center (hereinafter referred to as the State Bureau Audit and Inspection Center), State Drug Administration Drug Evaluation Center, State Drug Administration Administrative Matters Acceptance Service and Complaint Reporting Center, State Drug Administration Information Center and other professional and technical institutions According to the responsibilities of the implementation of medical device supervision and management of medical device standards management, classification definition, inspection, verification, monitoring and evaluation, certification delivery and the corresponding information construction and management and other related work.

Article 6 The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the registration-related management of the following medical devices within their administrative regions.

(i) Review and approval of registration of Class II medical devices within the territory.

(ii) Verification of quality management systems for Class II and Class III medical devices within the territory.

(iii) The organization of medical device clinical trial institutions and the supervision and management of clinical trials in accordance with the law.

(d) the supervision and guidance of the departments responsible for drug supervision and management at the municipal level within the territory of the first class medical device filing.

Provinces, autonomous regions and municipalities directly under the Central Drug Administration set up or designated medical device professional and technical institutions, to undertake the implementation of medical device supervision and management of the necessary technical review, inspection, verification, monitoring and evaluation of work.

The municipal department responsible for drug supervision and management is responsible for the record management of Class I medical device products within the territory.

Article 7 medical device registration and record management follow the principles of law, science, openness, fairness and justice.

Article 8 of the first class medical devices to implement product record management. Class II and Class III medical devices shall be managed by product registration.

The filing of Class I medical devices within the territory, the filer submits the filing information to the municipal department responsible for drug supervision and management in the district.

Domestic Class II medical devices are reviewed by the drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government, and a medical device registration certificate is issued after approval.

Domestic Class III medical devices are reviewed by the State Drug Administration and issued a medical device registration certificate after approval.

Imported Class I medical devices for the record , the filer submits filing information to the State Drug Administration.

Imported Class II and Class III medical devices are reviewed by the State Drug Administration and issued with medical device registration certificates after approval.

Article 9 the medical device registrant, the filer shall strengthen the quality management of the entire life cycle of medical devices, the development, production, operation, use of the entire process of medical device safety, effectiveness and quality control according to law.

Article 10 of the State Drug Administration to implement priority approval of medical devices in urgent clinical need, the implementation of special approval of innovative medical devices to encourage research and innovation of medical devices, and promote the development of medical device industry of high quality.

Article 11 the State Drug Administration to establish and improve medical device standards, technical guidelines and other systems to regulate the technical review of medical devices and quality management system verification, guidance and services for medical device research and development and registration applications.

Article 12 the drug supervision and management departments in accordance with the law and timely public medical device registration, filing-related information, the applicant can query the progress and results of approval, the public can access the approval results.

Without the consent of the applicant, the drug supervision and management department, professional and technical institutions and their staff, experts involved in the evaluation and other personnel shall not disclose commercial secrets, undisclosed information or confidential business information submitted by the applicant or the person of record, except as otherwise provided by law or where national security or significant social public interests are involved.

Chapter II. Basic requirements

Article 13 medical device registration, filing shall comply with relevant laws, regulations, rules and mandatory standards, follow the basic principles of medical device safety and performance, with reference to relevant technical guidelines to prove that the registered and filed medical devices are safe, effective and quality controllable, to ensure that the whole process information is true, accurate, complete and traceable.

Article 14 applicants and filers shall be enterprises or development institutions capable of assuming appropriate legal responsibilities.

Foreign applicants and filers shall designate an enterprise legal person in China as an agent to handle the registration and filing of relevant medical devices. The agent shall assist the registrant or filer in fulfilling the obligations stipulated in paragraph 1 of Article 20 of the Regulations for the Supervision and Administration of Medical Devices, and assist the overseas registrant or filer in implementing the corresponding legal responsibilities.

Article 15 The applicant, the filer shall establish a quality management system appropriate to the product, and maintain effective operation.

Article 16 for medical device registration, filing matters should have the appropriate professional knowledge, familiar with medical device registration, filing management of laws, regulations, rules and registration management related provisions.

Article 17 of the application for registration or for the record, should be in accordance with the State Drug Administration on registration, filing requirements to submit relevant information, the applicant, the filer is responsible for the authenticity of the information.

Registration and filing materials shall be in Chinese. If the translation is based on foreign language materials, the original language shall be provided at the same time. When citing unpublished literature, the document of permission for use by the right holder of the information shall be provided.

Article 18 the application for registration of imported medical devices, for the record of imported medical devices, should be submitted to the applicant, the filer's place of registration or production in the country (region) competent authorities to permit the medical device on the market sales documents.

If the applicant or the filer's country (region) of registration or production does not manage the product as a medical device, the applicant or the filer shall provide relevant documents, including the document certifying that the country (region) of registration or production permits the product to be marketed and sold.

Innovative medical devices that are not marketed in the country (region) where the applicant, filer is registered or where the production site is located are not required to submit relevant documents.

Article 19 medical devices shall comply with the applicable mandatory standards. Product structural features, intended use, use, etc. and the scope of application of mandatory standards are inconsistent, the applicant, the filer shall submit a statement of non-applicable mandatory standards and provide relevant information.

Where there are no mandatory standards, applicants and filers are encouraged to adopt the recommended standards.

Article 20 medical device registration, filing work shall follow the relevant requirements of the medical device classification rules and classification catalog.

Article 21 The drug supervision and management departments continue to promote the reform of the review and approval system, strengthen scientific research on medical device supervision, establish a technical review-led, verification, inspection, monitoring and evaluation of medical device registration and management technology system, optimize the review and approval process, improve review and approval capabilities, and enhance the quality and efficiency of review and approval.

Article 22 The medical device professional and technical institutions to establish and improve the communication system, clear the form and content of communication, according to the work needs of the organization and the applicant to communicate.

Article 23 medical device professional and technical institutions in accordance with the needs of the work of the establishment of expert consultation system, in the review, verification, inspection and other processes on major issues to listen to expert advice, give full play to the role of technical support of experts.

Chapter III Registration of medical devices

Section I. Product development

Article 24 medical device development should follow the principles of risk management, taking into account the current state of accepted technology, to ensure that all known and foreseeable risks and unintended effects of the product are minimized and acceptable, and to ensure that the benefits of the product outweigh the risks in normal use.

Article 25 engaged in medical device product development and experimental activities, shall comply with the relevant laws, regulations and mandatory standards and other requirements of China.

Article 26 The applicant, the filer shall prepare an application for registration or for the filing of medical devices product technical requirements.

The product technical requirements mainly include functional and safety indicators and testing methods that can be objectively determined for finished medical devices.

Medical devices should comply with the technical requirements of the registered or filed products.

Article 27 The applicant, the filer shall prepare an application for registration or for the filing of medical devices product specification and labeling.

Product instructions and labels shall comply with the requirements of Article 39 of the Regulations for the Supervision and Administration of Medical Devices and related regulations.

Article 28 medical device development, should be based on the scope of application of the product and technical characteristics of medical devices non-clinical research.

Non-clinical studies include product chemical and physical properties studies, electrical safety studies, radiation safety studies, software studies, biological characterization studies, biogenic material safety studies, disinfection and sterilization process studies, animal testing studies, stability studies, etc.

Applications for registration or filing should be submitted with non-clinical evidence generated from the development activities, including a review of non-clinical study reports, study protocols and study reports.

Article 29 The functional and safety indicators and methods determined in the process of non-clinical research of medical devices shall be compatible with the intended conditions of use and purpose of the products, and the research samples shall be representative and typical. When necessary, methodological validation and statistical analysis shall be conducted.

Article 30 application for registration or for the record, shall be tested in accordance with the technical requirements of the product, and submit an inspection report. If the test is qualified, the clinical trial or application for registration or filing can be carried out.

Article 31 test products should be able to represent the application for registration or for the record product safety and effectiveness, and its production should be in line with the relevant requirements of the medical device production quality management practices.

Article 32 The application for registration or for the record to submit the medical device product inspection report can be the applicant, the filer's self-test report, but also can be commissioned by a qualified medical device inspection agency issued the inspection report.

Section II Clinical Evaluation

Article 33 In addition to the circumstances specified in Article 34 of these measures, medical device product registration, filing, clinical evaluation shall be conducted.

Clinical evaluation of medical devices refers to the activity of analyzing and evaluating clinical data using scientific and reasonable methods to confirm the safety and effectiveness of medical devices within their scope of application.

Application for registration of medical devices should be submitted with clinical evaluation information.

Article 34 exempts from clinical evaluation any of the following circumstances.

(i) The working mechanism is clear, the design is well established, the production process is mature, the same species of medical devices that have been marketed have been clinically used for many years and have no record of serious adverse events and do not change their routine use.

(ii) Other non-clinical evaluations that can demonstrate the safety and effectiveness of the medical device.

Exemptions from clinical evaluation may be granted for the submission of clinical evaluation information.

The catalogue of medical devices exempted from clinical evaluation is formulated, adjusted and published by the State Drug Administration.

Article 35 to carry out clinical evaluation of medical devices, can be based on product characteristics, clinical risks, existing clinical data and other circumstances, by conducting clinical trials, or through the same species of medical devices clinical literature, clinical data analysis and evaluation, to prove the safety and effectiveness of medical devices.

In accordance with the provisions of the State Drug Administration, the clinical evaluation of medical devices, the available clinical literature, clinical data is not sufficient to confirm the safety and effectiveness of the product of medical devices, should be carried out clinical trials.

The State Drug Administration has formulated guidelines for clinical evaluation of medical devices to clarify the requirements for clinical evaluation through clinical literature information and clinical data of the same species of medical devices, the circumstances requiring clinical trials, and the requirements for writing clinical evaluation reports, etc.

Article 36 clinical evaluation through the same species of medical device clinical literature information, clinical data, clinical evaluation information including the application for registration of the product and the same species of medical devices, the same species of medical devices, the analysis and evaluation of clinical data, the application for registration of the product and the same species of products when there are differences in scientific evidence and evaluation conclusions.

If clinical evaluation is conducted through clinical trials, clinical evaluation information includes clinical trial protocols, ethics committee opinions, informed consent forms, clinical trial reports, etc.

Article 37 to carry out clinical trials of medical devices, should be in accordance with the requirements of the medical device clinical trial quality management standard, in accordance with the appropriate conditions and in accordance with the provisions of the record of the medical device clinical trial institutions. Before the start of the clinical trial, the clinical trial sponsor shall file the clinical trial with the drug administration department of the province, autonomous region or municipality directly under the Central Government. The production of clinical trial medical devices shall comply with the relevant requirements of the Code of Quality Management for the Production of Medical Devices.

Article 38 of the third category of medical devices for clinical trials on the human body has a higher risk, should be approved by the State Drug Administration.

Clinical trial approval refers to the process by which the State Drug Administration, based on the applicant's application, conducts a comprehensive analysis of the degree of risk of the medical device to be tested in clinical trials, the clinical trial protocol, and the report on the comparative analysis of clinical benefit and risk, in order to decide whether to agree to conduct clinical trials.

The third category of medical devices subject to clinical trials for approval is formulated, adjusted and published by the State Drug Administration. Clinical trials of Class III medical devices subject to clinical trial approval shall be conducted in Class III Class A medical institutions that meet the requirements.

Article 39 of the need for clinical trials of medical devices for approval, the applicant shall submit the application information such as review data, research data, clinical data, product specification and labeling samples in accordance with the relevant requirements.

Article 40 The National Bureau Device Review Center shall review the accepted clinical trial applications. The decision on whether to agree or not to agree to the clinical trial application shall be made within 60 days from the date of acceptance of the application, and the applicant shall be notified through the website of the Device Review Center of the National Bureau. If the applicant is not notified after the deadline, it shall be regarded as consent.

Article 41 If the applicant is required to make corrections during the review process, the National Bureau of Device Review Centre shall inform the applicant of all the corrections required at one time. The applicant shall, within one year of receiving the notice of correction, provide additional information in accordance with the requirements of the notice of correction. Upon receipt of the additional information, the National Bureau's device review centre shall complete the technical review in accordance with the prescribed time limit.

If the applicant disagrees with the content of the correction notice, he or she may submit written comments to the National Bureau of Device Review Center, stating the reasons and providing the corresponding technical support information.

If the applicant fails to submit additional information after the deadline, the technical review is terminated and a decision of non-approval is made.

Article 42 for medical devices during clinical trials of serious adverse events related to clinical trial medical devices, or other serious safety risk information, clinical trial sponsors shall, in accordance with the relevant requirements, respectively, to the location and clinical trial institutions in the province, autonomous region, municipality directly under the Central Drug Administration report, and take risk control measures. If risk control measures are not taken, the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government shall order the sponsor to take appropriate risk control measures.

Article 43 of the medical device clinical trials in a wide range of clinical trials of medical devices related to serious adverse events, or other major safety issues, the sponsor shall suspend or terminate the clinical trials of medical devices, respectively, to the location and clinical trial institutions located in the provinces, autonomous regions and municipalities directly under the Central Drug Administration and Management Department report. Failure to suspend or terminate, the provincial, autonomous region or municipality directly under the Central Drug Administration shall order the sponsor to take appropriate risk control measures.

Article 44 has been approved to carry out clinical trials, one of the following circumstances, the State Drug Administration may order the applicant to terminate the clinical trials of medical devices have been carried out.

(i) False information on clinical trial applications.

(ii) Where recent studies have confirmed the ethical and scientific validity of the originally approved clinical trial.

(iii) Other circumstances warranting termination.

Article 45 The clinical trial of medical devices shall be implemented within 3 years after approval; if no subject has signed the informed consent within 3 years from the date of approval of the application for clinical trial of medical devices, the permit for the clinical trial of medical devices shall expire by itself. If the clinical trial is still needed, a new application shall be made.

Article 46 For medical devices undergoing clinical trials for the treatment of serious life-threatening diseases for which there is no effective treatment, which may benefit patients after medical observation, may be used free of charge for other patients with the same condition within the institution conducting the clinical trial of the medical device after ethical review and informed consent, and their safety data may be used for medical device registration applications.

Section III. Verification of the registration system

Article 47 The applicant shall submit an application for registration and product development, production-related quality management system information, accept the application for registration of drug supervision and management departments in the technical review of the product that it is necessary to verify the quality management system, should be organized to carry out quality management system verification, and can access the original information as needed.

Article 48 The verification of the quality management system of Class III medical devices within the territory shall be notified by the National Bureau of Device Review Center to the provincial, autonomous region or municipality directly under the Central Drug Administration of the applicant's location.

Verification of the quality management system of Class II medical devices within the territory shall be organized by the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government where the applicant is located.

Article 49 The provincial, autonomous regions, municipalities directly under the Central Drug Administration in accordance with the requirements of the medical device production quality management standard to carry out quality management system verification, focusing on whether the applicant in accordance with the requirements of the medical device production quality management standard to establish a quality management system appropriate to the product, as well as product development, production-related design and development, production management, quality control and other content for verification.

In the verification process, the authenticity of the products for testing and clinical trial products should be verified at the same time, focusing on the design and development process related records, as well as the production process of products for testing and clinical trial products related records.

The submission of self-test report, the applicant, the person of record or the entrusted agency to develop the process of testing capabilities, test results and other key verification.

Article 50 provinces, autonomous regions and municipalities directly under the Central Drug Administration can carry out quality management system verification by means of data review or on-site inspection. According to the specific circumstances of the applicant, supervision and inspection, the application for registration of the product and has previously passed the verification of product production conditions and process comparison, to determine whether the on-site inspection and inspection content, to avoid duplication of inspection.

Article 51 The National Bureau of Equipment Review Center for imported Class II and Class III medical devices to carry out technical review, that it is necessary to carry out quality management system verification, notify the National Bureau of Audit and Inspection Center in accordance with the relevant requirements to carry out verification.

Chapter IV. Product registration

Article 52 The applicant shall, after completing the safety and efficacy studies supporting the registration of medical devices and preparing for the verification of the quality management system, submit an application for registration of medical devices and, in accordance with the relevant requirements, submit the following registration application information to the drug regulatory authority through online registration applications and other means.

(i) Information on product risk analysis.

(ii) Product technical requirements.

(iii) Product inspection reports.

(iv) Clinical evaluation information.

(v) Product instructions and sample labels.

(vi) Quality management system documents related to product development and production.

(vii) Other information required to prove the safety and effectiveness of the product.

Article 53 the drug supervision and management department received the application to review the application information, and according to the following circumstances to make separate processing.

(a) The application shall be accepted if it falls within the competence of the administrative organ and if the application information is complete and meets the requirements for formal examination.

(ii) If there are errors in the application data that can be corrected on the spot, the applicant shall be allowed to correct them on the spot.

(c) If the application information is incomplete or does not conform to the statutory form, the applicant shall be informed on the spot or within five days of the need to make corrections in full; if not so informed, the application shall be accepted from the date of receipt of the application information.

(d) If the application does not fall within the competence of the administrative organ in accordance with the law, a decision of inadmissibility shall be made immediately and the applicant shall be informed to apply to the relevant administrative organ.

Drug supervision and management departments to accept or reject the application for registration of medical devices, shall be issued under the special seal of the administrative organ and the date of the notice of acceptance or non-acceptance.

After the application for registration of medical devices is accepted, if the applicant is required to pay the fee, the applicant shall pay the fee in accordance with the regulations. If the applicant fails to pay the fee within the prescribed period, the applicant shall be deemed to have withdrawn the application on his own initiative and the drug supervision and management department shall terminate the registration procedure.

Where the technical review process requires the applicant to make corrections, the technical review body shall inform the applicant of all the corrections required in one go. The applicant shall, within one year of receipt of the notification of corrections, provide the additional information at one time in accordance with the requirements of the notification of corrections; upon receipt of the additional information, the technical review body shall complete the technical review within the prescribed time limit.

If the applicant disagrees with the content of the notice of correction, he or she may submit written comments to the corresponding technical review body, stating the reasons and providing the corresponding technical support information.

If the applicant fails to submit additional information after the deadline, the technical review is terminated and the drug regulatory authority makes a decision not to register the applicant.

Article 55 For the accepted application for registration, the applicant may, before the administrative licensing decision is made, apply to the drug supervision and administration department receiving the application to withdraw the application for registration and related information, and state the reasons. Agree to withdraw the application, the drug supervision and management department to terminate its registration procedures.

The review, verification and approval process found that there is suspected of concealing the true situation or providing false information and other illegal acts, according to the law, the applicant shall not withdraw the medical device registration application.

Article 56 for the accepted registration application, there is evidence that the registration application information may be false, drug supervision and management departments may suspend the review and approval. After verification, the review shall be continued or a decision not to register shall be made in accordance with the conclusion of the verification.

Article 57 During the review of medical device registration applications, the technical review body shall inform the applicant of the reasons for not passing the review, and the applicant may raise objections to the technical review body within 15 days, which shall be limited to the original application and the original application data. The technical review body shall make a comprehensive assessment in conjunction with the applicant's objections and provide feedback to the applicant. The objection processing time shall not be counted as part of the review time limit.

Article 58 The drug supervision and administration department receiving the registration application shall, after the completion of the technical review, make a decision on whether to approve. To meet the requirements of safety, effectiveness and quality control, registration shall be granted and the medical device registration certificate shall be issued, and the approved technical requirements of the product shall be sent to the applicant in the form of an attachment. In the case of non-registration, the reasons shall be stated in writing and the applicant shall be informed of the right to apply for administrative reconsideration or to institute administrative proceedings in accordance with the law.

The medical device registration certificate is valid for 5 years.

Article 59 For the accepted registration application, the drug supervision and management department shall make a decision not to register and inform the applicant if any of the following circumstances apply.

(a) The applicant's research on the safety, effectiveness and quality control of the medical device to be marketed and sold and its results cannot prove the safety, effectiveness and quality control of the product.

(b) Failure of quality management system verification, and refusal of the applicant to accept on-site inspection of the quality management system.

(d) Confusion and contradiction in the content of the registration application data, the content of the registration application data is clearly inconsistent with the items applied for and cannot prove that the product is safe, effective and of controllable quality.

(e) Other cases of non-registration.

Article 60 the laws, regulations, rules and regulations on the implementation of administrative licensing shall be heard, or drug supervision and management departments believe that the need for a hearing on other major administrative licensing matters involving public interest, drug supervision and management departments shall be announced to the public, and hold hearings. If the application for registration of medical devices directly involves the significant interests between the applicant and others, the drug supervision and management department shall inform the applicant and the interested party of the right to request a hearing before making the administrative licensing decision.

Article 61 the medical device for the treatment of rare diseases, serious life-threatening diseases and no effective treatment means and respond to public health events and other urgent needs, the drug supervision and management department can make a conditional approval decision, and in the medical device registration certificate contains the expiration date, the need to continue to complete the research work after the market and the completion time frame and other related matters.

Article 62 for the conditional approval of medical devices, the registrant shall collect data related to benefits and risks after the medical device is marketed, continuously monitor and assess the benefits and risks of the product, take effective measures to actively control risks, and complete the study and submit relevant information within the specified period in accordance with the requirements.

Article 63 for the conditional approval of medical devices, the registrant is overdue to complete the study in accordance with the requirements or can not prove that the benefits outweigh the risks, the registrant shall promptly apply for cancellation of medical device registration certificate procedures, drug supervision and management departments may cancel the medical device registration certificate in accordance with law.

Article 64 for the newly developed medical devices not yet included in the classification list, the applicant can directly apply for registration of the third class medical device products, but also based on the classification rules to determine the product category and apply to the State Drug Administration to confirm the category, apply for product registration or product record.

Directly apply for registration of Class III medical devices, the State Drug Administration in accordance with the degree of risk to determine the category. Domestic medical devices identified as Class II or Class I, the applicant should be informed to apply for registration or for filing with the appropriate drug regulatory authority.

Article 65 has been registered medical devices, its management category from the high category adjusted to a lower category, the medical device registration certificate continues to be valid during the validity period. The expiration of the validity period needs to be renewed, should be in the medical device registration certificate expires six months before, in accordance with the adjusted category to the corresponding drug supervision and management department to apply for renewal of registration or for the record.

Medical device management category from a low category to adjust to a high category, the registrant shall apply for registration in accordance with the changed category to the appropriate drug regulatory authority. State Drug Administration in the management category adjustment notice should be made to complete the adjustment of the time limit.

Article 66 of the medical device registration certificate and its accessories lost or destroyed, the registrant shall apply to the original issuing authority for a replacement, the original issuing authority to verify the replacement.

Where disputes over patent rights arise during the examination process of the registration application and after its approval, they shall be dealt with in accordance with the provisions of relevant laws and regulations.

Special registration procedures

Section I. Innovative product registration procedures

Applicants for medical devices that meet the following requirements may apply for the application of the innovative product registration procedure under Article 68.

(a) The applicant, through his or her leading technological innovation activities, has the right to patent the invention of the core technology of the product in China in accordance with law, or has obtained the right to patent the invention or its use in China through assignment in accordance with law, and the application for the application of the innovative product registration procedure is within five years from the date of announcement of the patent grant; or the application for the patent of the invention of the core technology has been made public by the patent administration department of the State Council, and a patent search report has been issued by the State Intellectual Property Office. Search and Consultation Center issued a search report stating that the core technical solution of the product has novelty and inventiveness.

(b) The applicant has completed preliminary research on the product and has a basic finalized product, the research process is authentic and controlled, and the research data are complete and traceable.

(c) The main working principle or mechanism of action of the product is the first of its kind in China, and the performance or safety of the product has been fundamentally improved compared with similar products, and is at the international leading level in terms of technology, and has significant clinical application value.

Article 69 application for the application of innovative product registration procedures, the applicant should be in the product is basically finalized, the State Drug Administration to submit an application for review of innovative medical devices. The State Drug Administration to organize experts to review, meet the requirements, into the innovative product registration procedures.

Article 70 for the application of innovative product registration procedures for medical device registration applications, the State Drug Administration, as well as to undertake the relevant technical work of the institutions, according to their respective responsibilities to designate a person responsible for timely communication, to provide guidance.

For medical devices included in the registration process of innovative products, the Device Review Center of the National Bureau can communicate with the applicant before the acceptance of the registration application and during the technical review process on major technical issues in the development of the product, major safety issues, clinical trial protocols, summary and evaluation of the results of the phase clinical trials, etc.

Seventy-one into the innovative product registration process of medical devices, the applicant took the initiative to request the termination or the State Drug Administration found that no longer meet the requirements of the innovative product registration process, the State Drug Administration to terminate the relevant products and inform the applicant of the innovative product registration process.

Article 72 for the medical device included in the innovative product registration procedure, the applicant does not apply for registration within the specified period, the innovative product registration procedure shall no longer apply.

Section II. Priority registration procedures

Article 73 medical devices meeting one of the following circumstances may apply for the application of priority registration procedures.

(a) Medical devices that diagnose or treat rare diseases or malignant tumours and have obvious clinical advantages, diagnose or treat diseases specific to and prevalent in the elderly and for which no effective diagnostic or therapeutic means are available, are used exclusively for children and have obvious clinical advantages, or are in urgent clinical need and for which no product of the same type has been approved for registration in China.

(b) Medical devices included in national science and technology major special projects or national key research and development programmes.

(c) The State Drug Administration provides for other medical devices that can be subject to priority registration procedures.

Article 74 application for the application of priority registration procedures, the applicant should be in the application for registration of medical devices, the State Drug Administration to apply for priority registration procedures. Belong to the first case of Article 73, the State Drug Administration to organize experts to review, in line with the priority registration procedures; belong to the second case of Article 73, the State Bureau of device review center to review, in line with the priority registration procedures; belong to the third case of Article 73, the State Drug Administration to listen to a wide range of views, and the organization of expert evidence to determine Whether to include priority registration procedures.

Article 75 of the priority registration procedures for medical devices into the registration application, the State Drug Administration priority for review and approval, provinces, autonomous regions, municipalities directly under the Central Drug Administration priority arrangements for medical device registration quality management system verification.

In the process of technical review of medical device products included in the priority registration procedure, the National Bureau's device review center shall actively communicate with the applicant in accordance with relevant regulations, and when necessary, special communication can be arranged.

Section III. Emergency registration procedures

Article 76 of the State Drug Administration can be required by law for emergency public health emergencies and there is no similar products listed in China, or although there are similar products listed in China, but the supply of products can not meet the emergency needs of public health emergencies to implement emergency registration of medical devices.

Article 77 application for the application of emergency registration procedures, the applicant shall apply to the State Drug Administration for emergency registration. If the conditions are met, included in the emergency registration procedures.

Article 78 of the implementation of emergency registration of medical device registration applications, the State Drug Administration in accordance with the unified command, early intervention, with the review, scientific approval requirements for processing, parallel medical device product inspection, system verification, technical review and other work.

Chapter V. Change of registration and renewal of registration

Section I. Change of registration

Article 79 The registrant shall take the initiative to conduct post-marketing studies on medical devices to further confirm the safety, effectiveness and quality control of medical devices and strengthen the continuous management of listed medical devices.

Registered Class II and Class III medical device products, t heir design, raw materials, production processes, scope of application, methods of use and other substantive changes that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for changes in registration procedures; other changes shall be filed with the original registration department within 30 days of the date of change.

The product name, model, specification, structure and composition, scope of application, technical requirements of the product, the address of the manufacturer of the imported medical device, etc., as set forth in the registration certificate, belong to the matters requiring change of registration as stipulated in the preceding paragraph. The name and residence of the registrant, the name and residence of the agent, etc., belong to the matters required to be filed under the preceding paragraph . Domestic medical device production address change, the registrant shall be for the record after the corresponding change in production license.

If other changes occur, the registrant shall do the relevant work in accordance with the requirements of the quality management system and report to the drug regulatory authority in accordance with the regulations.

Article 80 For a change in registration application, the technical review body shall focus on the part of the change for review, and form a review opinion on whether the changed product is safe, effective and of controllable quality.

In the technical review of the application for change of registration, if it is considered necessary to verify the quality management system, the drug supervision and management department shall organize the verification of the quality management system.

Article 81 medical device change registration documents and the original medical device registration certificate combined use, the expiration date of the same as the original medical device registration certificate.

Section II. Renewal of registration

Article 82 of the medical device registration certificate expires need to renew the registration, the registrant shall, six months before the expiration of the medical device registration certificate, apply to the original registration department for renewal of registration, and submit the application information in accordance with the relevant requirements.

Except for the circumstances provided for in Article 83 of these Measures, the drug regulatory authority that receives an application for renewal of registration shall make a decision to grant the renewal before the expiry of the medical device registration certificate. If the decision is overdue, the renewal shall be deemed to be granted.

Article 83 shall not be renewed if any of the following applies.

(a) Failure to submit an application for renewal of registration within the prescribed period.

(b) The new mandatory standards for medical devices are released and implemented, and the medical devices applying for renewal of registration cannot meet the new requirements.

(c) The medical device with conditional approval is not completed within the prescribed period of time for the matters contained in the medical device registration certificate.

Article 84 of the renewal of the registration of the approved time in the original registration certificate is valid, the renewal of the registration of the registration card validity start date for the next day of the expiry date of the original registration card; approved time is not in the original registration card validity, the renewal of the registration of the registration card validity start date for the approval of the renewal of the registration date.

Article 85 of the medical device registration application for change, renewal of registration application for acceptance and approval procedures, this chapter does not provide, the relevant provisions of Chapter III of these measures shall apply.

Chapter VI. Filing of medical devices

Article 86 before the production of Class I medical devices, should be product record.

Article 87 for the filing of medical devices, the filer shall, in accordance with the provisions of the Regulations for the Supervision and Administration of Medical Devices, submit the filing information to the drug regulatory authority to obtain a filing number.

Article 88 has been filed medical devices, the record information table and the record of the product technical requirements change, the filer shall change the record to the original filing department, and submit a description of the changes and related documents. Drug supervision and management department shall post the changes in the record information.

Article 89 has been filed in the medical device management category to adjust to the second or third class medical devices, shall apply for registration in accordance with the provisions of these measures.

Chapter VII. Time frame for work

Article 90 The time limit specified in these measures is the maximum time for the acceptance, technical review, verification and approval of medical device registration. Special registration procedures related to the work time frame, in accordance with the relevant provisions of the special registration procedures.

Professional and technical bodies such as the National Bureau's device review centres should clarify the work procedures and time limits of their units and make them publicly available.

After receiving the application for registration of medical devices and the application for clinical trial, the drug administration department of Article 91 shall forward the application information to the technical review agency within three days from the date of acceptance. The requirements for the acceptance of clinical trial applications shall apply to the provisions of Article 53 of these Measures.

Article 92 The time frame for the technical review of medical device registration shall be implemented in accordance with the following provisions.

(a) The time limit for the technical review of applications for clinical trials of medical devices is 60 days, and the time limit for the technical review of applications after correction of information is 40 days.

(b) The time limit for technical review of applications for registration of class II medical devices, applications for change of registration and applications for renewal of registration is 60 days, and the time limit for technical review of applications after correction of information is 60 days.

(c) The time limit for technical review of applications for registration of Class III medical devices, applications for change of registration and applications for renewal of registration is 90 days, and the time limit for technical review of applications after correction of information is 60 days.

Article 93 The time limit for verification of the quality management system of Class III medical devices within the territory shall be implemented in accordance with the following provisions.

(a) The National Bureau's device review centre shall notify the relevant provincial, autonomous region or municipality directly under the Central Government of the initiation of verification of the medical device registration application within 10 days of its acceptance.

(b) The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government shall, in principle, complete the verification within 30 days after receiving the notification of verification, and feedback the verification situation, verification results and other relevant materials to the National Bureau of Device Review Centre.

Article 94 The drug supervision and administration department receiving the application for registration shall make a decision within 20 days from the date of receipt of the review comments.

Article 95 The drug supervision and management department shall issue and deliver the relevant administrative license documents within 10 days from the date of the decision to approve the registration of medical devices.

Article 96 due to product characteristics and technical review, verification and other work encountered special circumstances do need to extend the time limit, the extension of the time limit shall not exceed one half of the original time limit, approved by the medical device technical review, verification and other relevant technical institutions, the extension of the time limit by the technical institutions to inform the applicant in writing, and notify other relevant technical institutions.

Article 97 The original issuing authority shall issue a replacement medical device registration certificate within 20 days from the date of receipt of the application.

Article 98 excludes the following from the relevant working time frame.

(i) The time taken by the applicant for additional information, post-verification corrections, etc..

(ii) Delays in verification due to the applicant.

(iii) The timing of external expert consultations, expert consultation meetings and joint reviews with drug review agencies required for pharmaceutical and medical combination products.

(iv) Where the review and approval process has been suspended in accordance with the provisions, the time taken up during the suspension of the review and approval process.

(v) The time taken up by quality management system verification.

The time limits set out in this Article 99 are calculated in working days.

Chapter VIII. Supervision and management

Article 100 drug supervision and management departments shall strengthen the supervision and inspection of medical device development activities, when necessary, can provide products or services for medical device development units and individuals to extend the inspection, the relevant units and individuals shall cooperate, provide relevant documents and information, shall not refuse, conceal, obstruct.

One hundred and one State Drug Administration to establish and step-by-step implementation of the unique identification system for medical devices, the applicant, the filer shall submit the unique identification-related information in accordance with the relevant provisions to ensure that the data is true, accurate and traceable.

Article 102 The State Drug Administration shall promptly notify the agent information to the agent's location in the provinces, autonomous regions and municipalities directly under the Central Drug Administration. Provinces, autonomous regions and municipalities directly under the Central Drug Administration to the administrative region of the agent organization to carry out daily supervision and management.

Article 103 of the provinces, autonomous regions, municipalities directly under the Central Drug Administration according to the medical device clinical trial institutions for the record, the organization has been filed in the administrative region of the clinical trial institutions to carry out post-filing supervision and inspection. For new filings of medical device clinical trial institutions, should be carried out within 60 days after filing supervision and inspection.

Provinces, autonomous regions and municipalities directly under the Central Drug Administration shall organize daily supervision and inspection of medical device clinical trial institutions in their administrative regions to comply with the quality management standards for medical device clinical trials, and supervise their continued compliance with the prescribed requirements. The State Drug Administration conducts supervision and inspection of medical device clinical trial institutions as needed.

Article 104 The drug supervision and administration department may conduct on-site inspection on the authenticity, accuracy, completeness, standardization and traceability of clinical trials if it considers necessary.

Article 105 to undertake the first class medical device product filing work of the drug supervision and management departments in the post-filing supervision, found that the filing information is not standardized, shall order the filer to correct the deadline.

Article 106 drug supervision and management departments do not timely find the systemic and regional risks of medical device registration and management in the administrative region, or do not timely eliminate the systemic and regional potential problems of medical device registration and management in the administrative region, the higher-level drug supervision and management department may interview the main person in charge of the lower-level drug supervision and management department.

Chapter IX. Legal liability

Article 107 violates the provisions of Article 79 of these Measures and fails to file the occurrence of changes in accordance with the requirements, it shall order rectification within a certain period of time; if it fails to do so, it shall be fined not less than 10,000 yuan but not more than 30,000 yuan.

Article 108 to carry out clinical trials of medical devices do not comply with the clinical trial quality management norms, in accordance with the "supervision and management of medical devices regulations" Article 94 to be punished.

Article 109 The medical device technical review body does not perform its duties in accordance with the provisions of these measures, resulting in major errors in the review, the department responsible for drug supervision and management shall order rectification, inform criticism, give a warning; if serious consequences are caused, the legal representative of the offending unit, the main person in charge, the person in charge directly responsible and other responsible personnel, shall be punished in accordance with law.

Article 110 Staff members of departments responsible for the supervision and administration of medicines who violate the provisions, abuse their powers, neglect their duties or engage in favouritism shall be punished in accordance with the law.

Chapter X. Annexes

Article 111 medical device registration or filing unit in principle to the product's technical principles, structural composition, performance indicators and scope of application as the basis for division.

Article 112 The medical device approved for registration refers to the medical device registration certificate and the limited content of the annexes and the medical device produced within the validity of the medical device registration certificate.

Article 113 of the medical device registration certificate in the "structure and composition" column contained in the combination of parts, for the purpose of replacement of consumables, after-sales service, maintenance, etc., for the original registered products, can be sold separately.

Article 114 The applicant in the application for registration of medical device products, change of registration, clinical trial approval can be authorized by the owner of the master file of medical devices, reference to the master file of registered medical devices. The work procedures related to the registration of medical device master file are separately stipulated.

Article 115 medical device registration certificate format by the State Drug Administration unified development.

The registration certificate number is organized as follows.

×1械注 ×2 ××××3 ×4 ×××5 ××××6

×1 is the abbreviation of the location of the registration approval authority.

"国" for domestic Class III medical devices and imported Class II and Class III medical devices.

The abbreviation for the province, autonomous region or municipality directly under the Central Government where the registration and approval department is located for Class II medical devices within the territory.

×2 for the form of registration.

The word "准" applies to medical devices in the territory.

The word "进" applies to imported medical devices.

The word "许" applies to medical devices in Hong Kong, Macao and Taiwan.

××××3 is the year of first registration.

× 4 for the product product category.

× × 5 is the product classification code.

××××6 is the first registration seria number.

For renewal of registration, the numbers of ××××3 and ××××6 remain unchanged. If the product management category is adjusted, the numbers should be renumbered.

Article 116 The filing number of Class I medical devices shall be arranged in the following manner.

× 1 械备 ××××2 ××××3. where.

×1 is the abbreviation of the location of the department of record.

"国" for imported Class I medical devices.

The first class of medical devices within the territory is the abbreviation of the province, autonomous region or municipality directly under the Central Government where the department of record is located plus the abbreviation of the municipal administrative region where the district is located (in the absence of the corresponding municipal administrative region, only the abbreviation of the province, autonomous region or municipality directly under the Central Government).

××××2 is the year of filing.

××××3 is the record running number.

Article 117 of the drug supervision and management departments to produce medical device registration certificate, change the registration documents electronic documents and paper documents have the same legal effect.

Article 118 According to the work needs, the State Drug Administration can be entrusted by law to the provinces, autonomous regions, municipalities directly under the Central Drug Administration or technical institutions, social organizations to undertake the specific work.

Article 119 provinces, autonomous regions, municipalities directly under the Central Drug Administration can refer to the provisions of Chapter IV of these measures to develop special registration procedures for Class II medical devices within the administrative region, and reported to the State Drug Administration for the record.

Article 120 medical device product registration fee items, fees and charges in accordance with the relevant provisions of the State Council departments in charge of finance and prices.

Article 121 The registration and filing of in vitro diagnostic reagents managed in accordance with medical devices shall be governed by the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents.

Article 122 The relevant provisions of the supervision and management of custom-made medical devices shall be separately formulated by the State Drug Administration.

The relevant provisions of the management of the registration of pharmaceutical and mechanical combination products, the State Drug Administration separately developed.

The relevant provisions of the emergency use of medical devices, by the State Drug Administration in conjunction with the relevant departments to develop separately.

Article 123 The registration and filing of medical devices in Hong Kong, Macao and Taiwan shall be handled with reference to imported medical devices.

Article 124 These Measures shall come into force on October 1, 2021. the "Measures for the Administration of Medical Device Registration" published by the former State Food and Drug Administration Order No. 4 of July 30, 2014 shall be repealed at the same time.

Medical device registration in Brazil

Sat, 19 Aug 2023 14:47:18 GMT

Medical Device Registration at ANVISA in Brazil

Regulation of Medical Device in Brazil

Brazil is a biggest Latin American country with population of over 200 Mio. residents. The medical device market has an attractive potential, however with complex regulatory requirements. Brazil's current medical device market worth is approximately $10.5 billion and imported medical devices account for 80 percen t of the market ( Meddeviceonline ).

The authority of medical device is Agência Nacional de Vigilância Sanitária (ANVISA) . Besides monitoring medical device , ANVISA is also responsible for Pesticides, Food, Cosmetics, Pharmacies and Drugstores, Pharmaceutical supplies, Medicines, Ports, Airports and Borders, Sanitarians, Blood, Tissues and Organs, Tabaco.

The main task of ANVISA is to promote the protection of the population’s health by executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies, as well as the control in ports, airports and borders.

Actually ANVISA keeps the Brazilian regulatory framework up-to-date at international level. In 2012 it co-founded the International Medical Device Regulators Forum (IMDRF) .

The most important legislatives are listed below:

•Law No. 6360/1976
•Decree No. 8077/2013, DECRETO - Health Surveillance
•Decree No. 79.094/1977, Classification and Registration Requirements for Medical Products
• RDC 751/2022 (replacing RDC 185/2021), Medical Device Registration
•RDC 211/2018, GMP for manufacturers of Medical Devices Resolution
• RDC 665/2022 (Replacing RDC RDC 16/2013), GMP Requirements for Medical Devices and IVDs
• RDC 687/2022 (replacing RDC 183/2017), Administrative processes applicable for granting GMP Certification for manufacturers of Medical Devices (Risk Classes III and IV)
•RDC 56/2001, Safety and Efficacy Requirements
•RDC 67/2009 and Resolution RDC 23/11, Post market surveillance

Prerequiste of Product Registration at ANVISA

The home country approval is not needed for medical device registration at ANVISA. However, the approval in EU, US, Japan, Australia and Canada can leverage the review process by Brazilian authority.

You need a Brazilian agent who has a business licence in Brazil and communicates with ANVISA in Portuguese .

Then you have to achieve Brazil Good Manufacturing Practice (GMP Certification) in prior to product registration of class III and IV medical device. Please be aware that the MDSAP certificate acts as only a good reference to accelerate GMP CERTIFICATION approval, however it doesn’t replace it.

Brazilian agent

It is also called Brazilian Registration Holder (BRH) . The role is very similar to US agent and Chinese agent of medical device and IVD whereby BHR owns the approval. Changing BRH requires a new registration.

To simplify sales activities of medical device in Brazil , an excellent solution is the hosting of registration with help of BRH. With Hosting Service, your company could submit product dossier benefiting sound regulatory affairs experience, without establishing a subsidiary in Brazil and get all licenses required by ANVISA. It also reduces time and cost without binding often to economic oriented distributors as BRH.

With hosting service, product registration will be issued on behalf of a third consulting party that has no sales activity, but only hosts registration and provides an import authorization for any distributors designated by manufacturers.

With hosting service, the manufacturers will have full control over product technical documents , so host is just a third contracted part because the rights are contractually limited to manufacturer.

The Brazilian Registration Holder will be responsible for maintaining the registration during its life time, and the manufacturers and its appointed distributors will have exclusive use of this record and service.

Product classification

In accordance with RDC 751/2022 chapter II there are there are four classes of medical device in Brazil, I, II, III and IV (see Table 1 ). Very similar to Annex VIII Classification rules at MDR in Europe there are 22 classification rules pursuant to RDC 751/2022 in Brazil. Brazilian class I and IV medical device can be equivalently respectively seen as European class I and III under rough comparison. And Brazilian class II and III medical device corresponds to European class IIa and IIb .

If medical device manufacturers are unsure about classification, a system to apply for determination of classification of medical device can be used at ANVISA.

Notificação means abbreviated registration . It applied to class I and II medical device . From class III to IV there is a more complex registration process called Registro with more documents, GMP certificatio n an d often other certifications.

Table 1: Classification and type of registration of medical device in Brazil

Registration process of Medical Device in Brazil

Based on product classification the following registration process is illustrated:

At the beginning in accordance to classification rules , the product class should be defined, followed by a gap analysis fulfilling prerequisite of registration and checking existing documents depending on type of registration. For class III and IV medical device a GMP certification must be applicatd. If necessary, testing of INMETRO and ANATEL should be planned in time. After compilation of documents , the dossier in Portuguese will be submitted. The submission of documents to ANVISA must be made in electronic format through ANVISA‘s Electronic Petitioning System .

The second obstacle after documents and testing preparation is efficient reply by legal manufacturers in written upon authority’s deficiency request . With organised and strategic product registration there is no wonder of successful product approval at the end.

Cost and time

ANVISA fees for Medical Devices:

Class I and II (Low risk): About USD 190,00
Class III and IV (High Risk): About USD 890,00
GMP Certification: About USD 25.890,00

Time of ANVISA review (After submission)and testing:

Class I: 15 days
Class II: About 2 months
Class III and IV: 4 - 5 months

*for class III and IV medical device ANVISA issues a technical deficiency request with a 120day deadline.

GMP Certification: About 8 months.
INMETRO certificate: 4 - 6 months
ANATEL certificate: 4 - 6 months

Document at a glance

GMP Certification:

Manufacturing site: Total area, Area of the productive sector, Total number of employees, Number of employees in the production area and in the quality area;
Quality Manual;
List of all products manufactured on site;
Production flowchart
Audit report

INMETRO Certification:

Quality Manual
Risk management
Usability test report
List of critical components
Customer Complaints
Packaging and labelling info
Validation of software
Electric schematics, diagram of isolation regarding electronic medical device

What about the requirements of technicial dokumentation (RDC 751/2022)?

Some additional certifications

1. GMP Certification

GMP certification is one additional pre-step among registration process of medical device in Brazil. It applies only class III and IV medical device.

Requirements of GMP certification are very similar to QMSR at FDA in US according to RDC 665/2022 and RDC 687/2022.

The GMP certification is 2 years valid. After the first 2 years GMP Certification, overseas manufacturer should provide a self-inspection . After an assessment based on documental analysis (audit report within the scope of ISO 13485 and MDSAP), ANVISA would grant a GMP certification instead of a re-inspection on site of overseas manufacturers.

If the overseas manufacturers have MDSAP certifiate , it can facilitate obtaining of GMP Certification. It doesn’t mean that with MDSAP certificate it automatically complies with requirements of GMP Certification in Brazil!

2. INMETRO certificate

INMETRO certification is not only required for electro medical devices subject to IEC 60601, but also in scope of norms below with which medical device has to conform:

ISO 6875:1998: Dental patient chair
ISO 7785-1:1999: Dental handpieces – Part 1: High-speed air turbine handpieces
ISO 7785-2:2004: Dental handpieces – Part 2: Straight and geared angle handpieces
ISO 9680:2001: Dentistry - Operating lights
ISO 9919:1997: Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
ISO 11195:2000: Gas mixers for medical use – Stand-alone gas mixers
ISO 8835-2:2010: Inhalational anaesthesia systems – Part 2: Anaesthetic breathing systems
IEC 61689:1998: Ultrasonics – Physiotherapy systems – Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz.

Non-electrical medical products that require INMETRO certification include:

Needles

Syringes

Mattresses

Gloves

Breast implants

Mechanical wheelchairs

Handpieces

Infusion sets

The National Institute of Metrology, Standardization and Industrial Quality mandates accredited Certification Bodies (OCP/CB) to conduct certification.

Testing for electro-medical products performed outside Brazil is usually accepted. This option totally saves the cost and time instead of sending medical device to Brazil. After product approval by ANVISA, the medical device must bear an INMETRO mark as a label. The Inmetro certificate is 5 years valid.

NEW! Under Ordinance No. 384/2020 the inmetro certificate will NOT expire.

The workflow of INMETRO certification:

3. ANATEl certificate

The Agência Nacional de Telecomunicações (ANATEL) certificate applies medical device with telecommunication using use radio frequency (RF) spectrum or wireless communication, e.g. Bluetooth, Wi-Fi, etc.

For this certification it is like Chinese Type Testing at which the device has to be send to Brazil for testing.

Summary

The medical device registration in Brazil is not preconditioned with home country approval . It is ideally that legal manufacturer has a certificated QM system (ISO 13485 or 21 QSR 820) for register III/IV medical device.

Compared to other country`s official fee to register medical device, ANVISA fee remains quite attractive also under consideration that product certificate is 10 years valid .

For some electric medical devices or medical device with radio frequency (RF) spectrum or wireless communication it is of course indispensable to receive INMETRO and ANATEL certification .

Fortunately the submission dossier to ANNISA is mainly based on EU or US technical file which legal manufacturers don`t need to re-generate additionally, but only translate it in Portuguese .

With calculable review time of technical file by ANVISA and structured maintenance inspection of above mentioned certifications, Brazil is still an absolute worthy medical device market to enter.

We can make KPI controlling of existing approval too. Book an appointment.

See our covered markets:

US, Canada , LAM, EU, Korea, Taiwan, ASEAN as Vietnam and Indonesia

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We have also global registration business

It makes headache for manufacturer of medical device, to go from MDR to FDA in US, ANVISA in Brazil or NMPA in China or conversely. Depending on ease of changing regulation, every market can be primary important, only if you understand the technical documentation as basis and country specific requirements.

Lets sail gobal with full compliance.

Chinese device description at technical documenttion

Mon, 10 Apr 2023 16:56:45 GMT

Device description in Chinese registration

Background of one of the most important registration documents

The document device description is well known chapter at product registration. Actually in every company this important document has a long revising lifecycle with diverse departments and different purposes. It is correctly controlled, clear understandable and compliant to different country-specific requirements? It is at least not exactly described for Chinese registration . Device descriptions are SEPERATED at Chinese dossier in different chapters and often most deficient parts by authority.

The basic requirements are already stipulated by IMDRF ( Non-In Vitro Diagnostic Device Market Authorization Table of Contents, 2019 ). In the guidance there is indication with country specific requirements in Canada, EU, Japan, Australia, US and China . We summarised the description items below which should be basic of your general device description:

· Intended use and indication

· Contra-indication and warning

· Environment

· Users

· Features, variants and operating modes

· Software function

· Product specification

· List of accessories

· Device combined to

· Components

· Sterilization method

· Composition of device, material specification and chemical composition direct or indirect contacting patient

· Biological material or deviate

· Active pharmaceutical ingredient

· Engineering diagrams/prints and schematics

Checklist of Chinese device description

Be careful there are several subchapters under main chapter CH 2 Summary maaterial at Chinese dossier . You have to find own tactic to reference these special requirements in early draft of R&D.

We just explained key subchapters which are always in misunderstanding, trouble and deficiency.

1. Chinese product name

Later before submission of the dossier, the product name in China should be fixed. The trivial mistake is to translate f oreign product name into Chinese. In China there is special naming rule for medical device. You can only have a general product name without adjective description. This product name should be consistent in the whole dossier (IFU, Label), though not necessary in V&V documentation and will be published in final Chinese certificate .

2. Chinese product variant, model, component, configuration and accessories (CH2.4.1)

We believe that you might have the same or different product variant and model in China . For the initial registration , please consider any variant covering this Chinese variant is i n home country approved because it is prerequisite to mark firstly medical device in China besides innovative products.

Functions, product features and operating modes, technical parameters , etc. belong to basic device description.

By listing components, configuration and accessories , don’t forget use diagram, photos, schematics, table and drawing to illustrate medical device. Keep in mind of sensible often changed critical parts to list exposed to reviewers if they are impacting safety and effective requirements. Derived from the mind of change registration by change of critical components, you have to describe them intelligently.

Besides basic description of subject medical device and its basic components, don’t ignore that software should be described as well. Behind listing different software unit/options what is the function in details ? It hides the product features which should not only understood by users but also by authority.

For passive medical device, raw material direct and indirect contacting patients should be listed or separated annexed.

3. Intended use and Patient population (CH2.5.1 and CH2.5.3)

In the chapter of intended use, you should have similar intended use which 1. under scope of “Chinese classification catalogue” . Formulate it generally and short. The intended use can be different in wording than the original intended use, however 2. not over the scope of original intended use in home country.

The patient population must be addressed as well as Patient Selection Criteria .

Subsequent to intended use subchapter CH2.5.1 there is a special subchapter CH2.5.3 “Use for child” where you have to specify the age of children and conditions to use medical device for children.

4. Device Packaging (CH2.4.2)

The description of Device Packaging in China is in a separate chapter into which should be taken account for sterile medical device and medical device with Microbial Limit Requirements . Often the reviewer asks the material of packaging und physical parameter of all levels of packaging.

5. R&D History (CH2.4.3)

It is written in EU MDR annex II and in Chinese guidance ( “Electronic table of content of medical device registration application materials” and “Requirements for application materials for medical device registration and formats of approval documents” ). Writting R&D history is perhaps not important for European notified body .

However for Chinese registration an equivalent device (either previous or similar ) should be referenced by telling the R&D story and the explanation of development of subject device based on equivalent device must be explicated.

6. Previous and similar device (CH2.4.4)

Here are some marks of substantial equivalence compassion in US. Different is that you have to compare to an equivalent medical device which was approved in China.

You should able to explain functional features. Not just for change registration, the equivalent device oft understood in China as previous or from competitor must be mentioned with marketing history (when approved in China). We recommend you to compare subject device with previous and similar device in a detailed comparison table with all aspects and comments about the difference if applicable. If the own previous device was in the case, a historic of development with changes should be written, akind of repeat of CH2.4.3.

Novel or new features

This is especially important for Chinese reviewer to understand what are new features at subject registration compared to previous device or other competitor device. The reviewer should easily follow the highlights in this registration which they will be under stringent review. It means that you should be ready to have evidence for the novel and new features in r isk management, verification internally or externally, clinical evidence if needed even in clinical study.

7. Compatibility with other medical device (CH 2.7)

If subject device can be combined to another in China approved medical devices or components . The registration info and specification of combination devices or components should be provided.

8. Keep or delete some country specific descriptions?

Must not include in Chinese device description

· The physical, chemical, mechanical and electrical properties are not sufficient if they were not needed to understand the whole product. These details and supporting testing are usually in chapter 3.

· Sales volumes in different country is in chapter x at Chinese dossier

· Chinese label is in chapter x at Chinese dossier

· Technical data is typically at the end of IFU. However some useful parameter can be used at chapter of device description as dimension, weight, typical functional parameters

· Country specific standard and regulation

· Country specific code (as in EU, MDA/MDN, MDS, MDT, basic UDI-DI)

Might include in Chinese device description

There are special descriptions in EU or US market having its p roduct code, classification, label, indication for use, different variants. In general it helps the reviewer to understand the different variants. If it was well structured instead of mixed described, this will not be an issue for device description in China.

Outlook of Chinese device description

Interface to other departments and documents

The research document device description is primary edited by department product mangement and proved by regulatory affairs, marketing, clinical affairs and R&D. In the reality it is a resource for instruction for use, for V&V testing of specifications, for clinical evaluation or study of claims, for external marketing material, for user scenarios of usability test . A well-structured device description acts as more than a product dictionary to look after all info related to products. It is a high-quality extract from all R&D departments. From each description you can find supporting material in “device history file” .

Understanding of smart device description

It is not surprised that many western manufacturers have always deficiency after dossier submission at Chinese registration. If you were smart, a general “all in one” device description can be written for all markets. You can mark the special chapters for Chinese registration and integrate it to each needed Chinese table of content. Or you can have a separated Chinese device description for Chinese model to be marked in China.

We experience a lot of device descriptions without any pictorial representation . If it was not secret and the subject has no continuous design change, we recommend manufacturers to explain the whole system with basic components, variants, accessories with pictures. Even for a complex function, use typical thought o f QM process ; make an easy work flow illustrating the user steps.

Depending on products, the length of device description is no longer than 40 page s.

Make reference document with exact numeric chapter at submitted dossier. The un-submitted internal documentation MUST NOT referenced to avoid that endless referenced documentation is under new interest to re-submit.

It is a foundation to have a plain device description beneficial internally, for product registration and for advertisement later . Make as much efforts to highlight your products marked globally. It is not just for authority or match of regulatory requirements, however a descriptive visit card for next victory.

Contact us

We can support you to deviate Chinese device description from e.g. EU MDR annex II using template and checklist.

Or you can write a compliant Chinese device registration on your own after our gap analysis.

How to search Chinese consultant (partner)?

Sat, 08 Apr 2023 15:01:20 GMT

How to search Chinese consultant (partner)?

Tags : Contract compliance, foreign manufacturers, Chinese partner, Chinese agent, outsourced project, Chinese distributor, medical device and IVD, EU Small and medium-sized enterprises, due diligence

Background and purpose of good Chinese consultant

It is always difficult to find a reliable and long term c onsultant or distributor or partner in China in life science sector. Even you have sound supplier qualification process compliant to ISO 13485, 7.4 Purchasing. If you audit your partner in China, there are another Chinese ( culture, local policy, communication and language ) impact factors.

Based on our experience we highlight some considerations for you to choose Chinese partner. It can be local representative for registration ( Chinese agent ), primary distributor, outsourced production, outsourced testing, joint venture and supplier of components.

The roles can be diverse and should be controlled with referenced Chinese and international regulation:

· Communication with authority

· Interface between overseas stakeholder and Chinese supply chain to end user

· Accountability during the whole life cycle of products in China

· Have quality management to monitor the quality of products

· Protection of Intellectual property

Must have consultant character of Chinese partner

It raises always need to reconsider good consultants during t he change of legislative, products and personal. The basic is contract which rules the principle and scope of the business. In the reality the hurdle are often accountable personal, misplanned projects and intransparent communications.

Contract with Chinese elements

We believe that every firm has its own template of contract with Chinese partner after typical NDA. However it is not specific enough to address the detailed service with extra cost, applicable chapter of law and controlling measure for quality.

The key for successful is not only time and cos t but also reliable partnership . For the first a rough timeline and extra cost should be listed at beginning of project. It is always rational to put additional cost in a separate annex to avoid open astronomic sum of payment. The reliable partnership can be proved after project start and long term collaboration.

From legal enforcement perspective, we see more and more bilingual contracts . By distribute both parties know their responsibility.

Besides it, we list the basic factors to consider in a bilateral contract:

· Start date of the project

· Condition of termination and change of the partner

· Proprietary right

· Confidentiality of the data

· Price of independent service

· Responsibility and liability

· Change assessment

· Distributor management

· Customer management (complaints)

Actually there are also offers or quotations for easy specular projects. Normally it is superficially formulated. Pay attention to feasibility of offer. It should content the tactic and details of projects. Sometime it makes sense to get a payed good offer.

Manpower is deciding

It is meant for both sites. It must not be fluent Chinese speaker. The manpower at Chinese project should be a person with patient, language, negotiation and flexibility skills . At brains it is better to have two gears to receive ,analysis, resolve and control the untypical questions .

Do you have years of Chinese partners without meeting them in a meeting or in the reality? This is No-GO. In Chinese culture we set value on personal relationship. A regular face to face meet up on - and off the project is recommended.

Project management with basic communication

We suggest to have a kick off meeting with new partner and challenge with some questions. So from beginning you know how Chinese partner handle the question W/O:

· Hundreds emails

· Proactive presentations

· Personal meeting invitation

· Direct telephone

· Hundreds person in downstream involved

· Thousands deciding canals

· Immediate cost

· Inefficient talking

What happens during and after project? Definitely you should have a controlling system. The tool can be milestone meeting with manager, meeting protocol to trace the question, communication matrix and KPI of projects .

Lessons learned are code of next successful, because the next project can be similar and the process might be the same.

Premium character of Chinese partner

You cant request your Chinese partners only from your views. Both parties should meet in the middle with each demand. Nevertheless if you wish a premium partner, we have some ideas.

Certification (global and Chinese)

Depending on which partner and in which international dimension, the recognised certification is reputable as ISO 9001, ISO 13485, ISO 15189 and ISO 17025 .

At least you should ask a copy of business licence of your partners in China. The sales partner must have Good Sales Practise Certificate, manufacturing partner Good Distribution Practise Certificate and testing lab CNAS .

Otherwise you can inspect your Chinese partner. We are surprised that many small Chinese companies have professional quality management behaviour without paper certification.

High level communication

As said before at project management it is universal chaos, even with increasing interdisciplinary topics, multidepartment and changing manpower. The scenarios for high level communication can be:

· A project leader with bilingual

· A key participant with tactic decision

· An uncomplicated decision policy in both parties

· Fantastic understanding of 2 contact person

· Impartial moderator

· Weekly (monthly) meeting

· Trouble tracing tool

· Pragmatic management of budget and time

In case of Chinese agent and Chinese distributor

1.Regulatory monitoring

The strengthened legislative in medical device and IVD in China forces Chinese agent and distributor not only follow corresponding regulations but also transfer the change of regulation earlier in English to overseas partners.

2.Product information (e.g. Labelling and UDI )

The products after approval in supply chain should be consistent with the model submitted to authority. If product change happens, Chinese agent should support to analysis whether it impacts safety and effective or raise new risk of products .

It is always mysterious which marketing material is at user. So better all involved parties have a backup of final Chinese instruction for use , label, UDI, issuance code, certification number , Chinese product name.

3. Recla mation, serious adverse event and recall

The accountability of post market after product approval needs co-working of both parties (legal representative and distributor) if they are not the same.

The easiest way is to rule these activities at each contract or post market amendment in a process who, till when and what to proactively to do. The outcomes are traceable post market records.

4.Training

Do you train your Chinese distributor in personal course; either in China or in headquarters? We are surprised that many Chinese distributors try to understand the products and troubleshoot on their own. Even the Chinese advertisement and material is limited correct without aligning with legal manufacturer.

5.Inspection

How does your Chinese distributor handle with storage, transport, good receipt, installation, maintenance, non-conformity, vigilance items and labelling of products ? As legal manufacturer, you have to inspect your critical Chinese partners.

6.Liability

Regarding liability it means registration as service for Chinese agent and products for Chinese distributor. EU SME might have not own subsidiary and have these 2 roles outsourced. You should ask yourself by drafting the contract: Are the terms of service or products clearly formulated? Who bears liability for regulatory obligatory (post market report) and adverse events?

7.Data protection and privacy

It cant control your partner in term of data protection and privacy with typical national laws. However, the basic requirements should be described to make them aware of data protection of all product- and project specific data beyond the third party.

8 .No-GO with Chinese partners (Best ECA practise)

So we try to be polite to formulate indirectly what is No-Gos in the medtech sector.

· No original certificate (without translation of key info)

· No copy of submitted registration dossier

· Intransparent communication in case of customer-related issuers as complaints

· More than 50% payment at earlier stage of project

· No detailed additional services with hourly or flat fee

· No active regulatory update

· No specialist with basic English

· No project management (too much reacting by doing)

· No notification by sub-contractor

What can we support?

· Chose a Chinese partner

· Audit your Chinese partner with defined quality management

· Provide a checklist in customer need for Chinese partner

· Distributor controlling with regulatory view

In Vitro Diagnostic Reagents Registration and Filing Management Measures, Order. 48 in 2021

Sat, 18 Feb 2023 16:47:36 GMT

Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents

No. 48 in 2021

original regulation in Chinese

The chinese version shall still prevail in actuality.

Tags: Regulations on Supervision and Administration of Medical Devices, Classification of IVD, Product technical requirement, Type testing , instruction for use and label , innovative products, QMS, imported Class II and Class III In Vitro Diagnostic, Clinical Evaluation , clinical trial, p roduct change , Product registration, Change registration, Renewal , technical review , chinese certificate of IVD, product name

Chapter I General Provisions

Chapter II Basic Requirements

Chapter III Registration of in vitro diagnostic reagents

Chapter IV Special Registration Procedures

Chapter V Change of registration and renewal of registration

Chapter VI In Vitro Diagnostic Reagents Filing

Chapter VII Working Time Limit (review time)

Chapter VIII Supervision and management

Chapter IX Legal Liability

Chapter X By-laws

Note

Product record management refers to I class IVD. Legal manufacturer = "filer"

Product registration management refers to II and III class IVD. Legal manufacturer = "applicant"

Chinese agent = "enterprise legal person"

Chapter I General Provisions

Article 1 In order to regulate the registration and filing of in vitro diagnostic reagents and ensure the safety, effectiveness and quality control of in vitro diagnostic reagents, these measures are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices .

Article 2 In the territory of the People's Republic of China to carry out in vitro diagnostic reagents registration, filing and its supervision and management activities, the present measures shall apply.

Article 3 These measures refer to in vitro diagnostic reagents managed according to medical devices, including in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health state evaluation, reagents, kits, calibrators, quality control products for in vitro testing of human samples, which can be used alone or in combination with instruments, apparatus, equipment or systems.

In vitro diagnostic reagents for blood screening and in vitro diagnostic reagents using radionuclide markers, which are managed according to pharmaceuticals, do not fall within the scope of management of these measures.

Article 4 Registration of in vitro diagnostic reagents refers to the application for registration of in vitro diagnostic reagents by the applicant (hereinafter referred to as the applicant) in accordance with the statutory procedures and requirements, and the drug supervision and administration department will review the safety, efficacy and quality control based on scientific knowledge in accordance with laws and regulations and decide whether to approve the application.

In vitro diagnostic reagents for the record refers to in vitro diagnostic reagents for the record (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the drug supervision and management departments to submit information for the record, the drug supervision and management departments to submit information for the record archives for inspection activities.

Article 5 The State Drug Administration is in charge of the national in vitro diagnostic reagent registration and filing management, responsible for the establishment of in vitro diagnostic reagent registration and filing management system, according to the organization of the domestic third class and the imported second class , the third class of in vitro diagnostic reagent review and approval, the imported first class of in vitro diagnostic reagent filing and related supervision and management work, the local in vitro diagnostic reagent registration and filing work supervision and guidance.

Article 6 The State Drug Administration Medical Device Technical Review Center (hereinafter referred to as the State Bureau of Device Review Center) is responsible for the technical review of the domestic third and imported second and third categories of in vitro diagnostic reagents product registration applications, applications for change of registration, renewal of registration applications, etc.

The State Drug Administration Medical Device Standards Management Center, the China Academy of Food and Drug Administration, the State Drug Administration Food and Drug Administration Food and Drug Audit and Inspection Center (hereinafter referred to as the State Bureau Audit and Inspection Center), the State Drug Administration Drug Evaluation Center, the State Drug Administration Administrative Matters Acceptance Service and Complaint Reporting Center, the State Drug Administration Information Center and other professional and technical institutions In vitro diagnostic reagents, in accordance with their responsibilities to implement the supervision and management of in vitro diagnostic reagents required for the management of in vitro diagnostic reagents standards, classification definition, testing, verification, monitoring and evaluation, certification and delivery and the corresponding information technology construction and management and other related work.

Article 7 The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the registration and management of the following in vitro diagnostic reagents within their administrative regions.

(a) In vitro diagnostic reagent registration review and approval for the domestic second class within the territory.

(b) the verification of the quality management system of in vitro diagnostic reagents of the domestic second and third categories within the territory.

(c) the organization of medical device clinical trial institutions and the supervision and management of clinical trials in accordance with the law.

(d) the supervision and guidance of the municipal departments responsible for drug supervision and management of the territory of the domestic first class of in vitro diagnostic reagents for the record.

Provinces, autonomous regions and municipalities directly under the Central Drug Administration set up or designated medical device professional and technical institutions to undertake the implementation of in vitro diagnostic reagents supervision and management of the technical review, testing, verification, monitoring and evaluation of work required.

Municipal departments responsible for drug supervision and management shall be responsible for the record management of the first class of in vitro diagnostic reagents within the territory.

Article 8 The registration and filing of in vitro diagnostic reagents shall follow the principles of law, science, openness, fairness and justice.

Article 9 The first class of in vitro diagnostic reagents shall be subject to product record management . The second class and the third class of in vitro diagnostic reagents shall be subject to product registration management .

For the filing of the domestic first class of in vitro diagnostic reagents within the territory, the filer shall submit the filing information to the municipal department in charge of drug supervision and management at the district level.

The second class of domestic in vitro diagnostic reagents within the territory is reviewed by the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government, and a medical device registration certificate is issued after approval.

The third class of domestic in vitro diagnostic reagents within the State Drug Administration review, approval issued after the registration certificate of medical devices.

Imported first class in vitro diagnostic reagents are for the record, the filer to the State Drug Administration to submit the record information.

Imported Class II, Class III in vitro diagnostic reagents are by the State Drug Administration review, approval issued after the medical device registration certificate.

Article 10 in vitro diagnostic reagents registrant, the filer shall strengthen the whole life cycle of in vitro diagnostic reagents quality management, the development, production, operation, use of the whole process of in vitro diagnostic reagents safety, efficacy and quality control according to the responsibility.

Article 11 The State Drug Administration implements priority approval of the urgent clinical needs of in vitro diagnostic reagents and encourages the research and innovation of in vitro diagnostic reagents, and promotes the high-quality development of the medical device industry.

Article 12 The State Drug Administration establishes and improves in vitro diagnostic reagents standards, technical guidelines and other systems, standardize in vitro diagnostic reagents technical review and quality management system verification, guidance and service in vitro diagnostic reagents research and development and registration applications.

Article 13 The drug supervision and management departments share be in accordance with the timely disclosure of in vitro diagnostic reagents registration, filing-related information, the applicant can query the progress and results of approval, the public can access the approval results.

Without the consent of the applicant, the drug supervision and management department, professional and technical institutions and their staff, experts involved in the evaluation and other personnel shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant or the filer, except as otherwise provided by law or in relation to national security or significant social public interests.

Chapter II Basic Requirements

Article 14 The registration and filing of in vitro diagnostic reagents shall comply with relevant laws, regulations, rules and mandatory standards, follow the basic principles of in vitro diagnostic reagent safety and performance, refer to relevant technical guidelines, prove that the registered and filed in vitro diagnostic reagents are safe, effective and of controllable quality, and ensure that the information is true, accurate, complete and traceable.

Article 15 Applicants and filers shall be enterprises or development institutions that can bear the corresponding legal responsibilities.

Foreign applicants and filers shall designate an enterprise legal person in China as an agent to handle the registration and filing of relevant in vitro diagnostic reagents. The agent shall assist the registrant or filer in fulfilling the obligations stipulated in Article 20(1) of the Regulations for the Supervision and Administration of Medical Devices, and assist the overseas registrant or filer in implementing the corresponding legal responsibilities.

Article 16 The applicant and the filer shall establish a quality management system related to the development and production of the product and maintain effective operation.

Article 17 The personnel handling the registration and filing of in vitro diagnostic reagents shall have relevant professional knowledge and be familiar with the laws, regulations, rules and registration management related to the registration and filing of in vitro diagnostic reagents.

Article 18 The application for registration or for the record, shall be in accordance with the State Drug Administration registration, filing requirements to submit relevant information, the applicant, the filer is responsible for the authenticity of the information.

Registration, filing information should be used in Chinese . According to the foreign language information translated, should also be provided in original. When citing unpublished literature, it should be provided the data rights holder permission to use the documents.

Article 19 Application for registration of imported in vitro diagnostic reagents and filing of imported in vitro diagnostic reagents shall be submitted to the competent authorities of the country (region) where the applicant, the filer's place of registration or production is located for approval of marketing.

If the product is not managed as a medical device in the country (region) where the applicant or the filer is registered or produced, the applicant or the filer shall provide relevant documents, including the documents certifying that the country (region) where the applicant or the filer is registered or produced permits the product to be marketed.

If the in vitro diagnostic reagents are not listed in the country (region) where the applicant or the filer is registered or where the production site is located in accordance with the registration procedure for innovative products, relevant documents need not be submitted.

Article 20 In vitro diagnostic reagents shall comply with the applicable mandatory standards. Product structural features, technical principles, intended use, use, etc. and the scope of application of mandatory standards are inconsistent, the applicant, the filer shall submit a statement of non-application of mandatory standards and provide relevant information.

If there is no mandatory standard, the applicant and the filer are encouraged to adopt the recommended standard.

Article 21 The registration and filing of in vitro diagnostic reagents shall follow the relevant requirements of the in vitro diagnostic reagent classification rules and classification catalogue.

Article 22 The drug supervision and management departments continue to promote the reform of the review and approval system, strengthen regulatory scientific research, establish a technical review-led, verification, testing, monitoring and evaluation of in vitro diagnostic reagent registration management technology system for support, optimize the review and approval process, improve the review and approval capabilities, and enhance the quality and efficiency of the review and approval.

Article 23 The medical device professional and technical institutions to establish and improve the communication system, clear communication form and content, according to the work needs of the organization and the applicant to communicate.

Article 24 medical device professional technical institutions according to the work needs to establish expert consultation system, in the review, verification, testing and other processes on major issues to listen to expert advice, give full play to the role of technical support of experts.

Chapter III Registration of in vitro diagnostic reagents

Section I Product Development

Article 25 The development of in vitro diagnostic reagents shall follow the principles of risk management, taking into account the existing level of recognized technology, to ensure that all known and foreseeable risks and unintended effects of the product are minimized and acceptable, and to ensure that the benefits of the product in normal use outweigh the risks.

Article 26 Research and development activities of in vitro diagnostic reagent product shall comply with the requirements of relevant laws, regulations and compulsory standards of China, etc.

Article 27 The applicant, the filer shall prepare the product technical requirements for application for registration or for filing of in vitro diagnostic reagents.

Product technical requirements mainly include functional and safety specification and testing methods for objective determination of the finished in vitro diagnostic reagents.

The third class of in vitro diagnostic reagents should be specified in the form of an appendix to the product technical requirements of the main raw materials and production process requirements.

In vitro diagnostic reagents shall comply with the technical requirements of the registered or filed products.

Article 28 The applicant, the filer shall prepare the application for registration or filing of in vitro diagnostic reagents product specification and labeling.

Instructions for use and labels shall comply with the "Supervision and Administration of Medical Devices Regulations" Article 39 requirements and related provisions.

Article 29 The development of in vitro diagnostic reagents shall be based on the intended use and technical characteristics of the products to carry out non-clinical studies of in vitro diagnostic reagents.

Non-clinical research refers to the testing or evaluation of in vitro diagnostic reagents under laboratory conditions, including the selection and preparation of major raw materials, product production processes, product analytical performance, positive judgment values or reference intervals, product stability and other research.

Application for registration or filing shall be submitted to the non-clinical evidence generated during the development activities.

Article 30 The functional and safety indicators and methods determined during the non-clinical research of in vitro diagnostic reagents shall be compatible with the intended use conditions and purposes of the products, and the research samples shall be representative and typical. When necessary, methodological validation and statistical analysis shall be conducted.

Article 31 application for registration or for the record, shall be tested in accordance with the technical requirements of the product, and submit a test report . Test qualified, before the clinical trial or application for registration, for the record.

Article 32 For same registration application including different packaging specifications, you can only carry out a packaging specification product testing, testing with products should be able to represent the application for registration or for the record product safety and efficacy, its production should be in line with the relevant requirements of the medical device production quality management practices.

Article 33 The application for registration or for the record can be self-test report , but also can be commissioned by a qualified medical device inspection agency to issue the inspection report.

Third Class in vitro diagnostic reagents should provide three different production batches of product inspection reports.

Article 34 For the applicable national standards, the national standards shall be used to test the reagents. The China Academy of Food and Drug Administration is responsible for organizing the preparation and calibration of national standards.

Section II Clinical Evaluation

Article 35 Clinical evaluation of in vitro diagnostic reagents refers to the process of using scientific and reasonable methods to analyze and evaluate clinical data to confirm whether the product meets the requirements for use or intended use, so as to prove the safety and effectiveness of in vitro diagnostic reagents.

Article 36 clinical trial of in vitro diagnostic reagents refers to the systematic study of the clinical performance of in vitro diagnostic reagents in the corresponding clinical environment.

The State Drug Administration to develop in vitro diagnostic reagents clinical trial guidelines, to clarify the requirements for conducting clinical trials, clinical trial report writing requirements, etc.

Article 37 to carry out clinical evaluation of in vitro diagnostic reagents, clinical trials should be conducted to prove the safety and effectiveness of in vitro diagnostic reagents.

Clinical trials may be exempted if the following circumstances are met.

(a) The reaction principle is clear, the design is stereotyped, the production process is mature, and the in vitro diagnostic reagents of the same species that have been marketed have been clinically applied for many years and have no record of serious adverse events and do not change their routine use.

(b) The safety and effectiveness of the in vitro diagnostic reagents can be proved by means of methodological comparison of the same species.

Exempt from clinical trials of the second class, the third class of in vitro diagnostic reagents directory by the State Drug Administration to develop, adjust and publish.

Article 38 For in vitro diagnostic reagents exempted from clinical trials, the applicant shall prove the safety and efficacy of the product through the methodological comparison of clinical samples of the same species that meet the intended use.

State Drug Administration to develop clinical evaluation of in vitro diagnostic reagents exempted from clinical trials related guidelines.

Article 39 clinical evaluation of in vitro diagnostic reagents refers to the applicant for clinical evaluation of the documents formed.

If clinical trials are conducted, the clinical trial data include clinical trial protocols, ethics committee opinions, informed consent, clinical trial reports and relevant data, etc.

For in vitro diagnostic reagents included in the catalogue of exempted clinical trials, the clinical evaluation information includes comparative analysis with similar products already on the market, methodological comparison data, analysis of relevant literature data and analysis of empirical data, etc.

Article 40 When the same registration application includes different package specifications, only one package specification may be used for clinical evaluation, and the product for clinical evaluation shall represent the safety and efficacy of the product applied for registration or for record.

Calibration products and quality control products do not need to submit clinical evaluation information when applying for registration alone.

Article 41 To carry out in vitro diagnostic reagents clinical trials, it should be in accordance with the requirements of the quality management standards for medical device clinical trials, in accordance with the appropriate conditions and in accordance with the provisions of the record of the medical device clinical trial institutions. Before the start of the clinical trial, the clinical trial sponsor shall file the clinical trial with the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government. The production of in vitro diagnostic reagents for clinical trials shall conform to the relevant requirements of the code of quality management for the production of medical devices.

Article 42 For serious adverse events related to in vitro diagnostic reagents in clinical trials during clinical trials, or other serious safety risk information, the clinical trial sponsor shall, in accordance with relevant requirements, report to the provincial, autonomous region or municipality directly under the central government drug supervision and management department of the location and clinical trial institution respectively, and take risk control measures. Failure to take risk control measures, the province, autonomous region or municipality directly under the Central Drug Administration shall order the sponsor to take appropriate risk control measures.

Article 43 In vitro diagnostic reagents clinical trials in a wide range of clinical trials of in vitro diagnostic reagents related to serious adverse events, or other major safety issues, the sponsor shall suspend or terminate the in vitro diagnostic reagents clinical trials, respectively, to the location and clinical trial institutions located in the province, autonomous region, municipality directly under the Central Drug Administration and Management Department report. If the clinical trial is not suspended or terminated, the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government shall order the sponsor to take appropriate risk control measures.

Article 44 When conducting clinical evaluation of in vitro diagnostic reagents expected to be used by consumers for personal use, the applicant shall also conduct an evaluation of the cognitive ability of consumers without medical background on the product instructions.

Article 45 For in vitro diagnostic reagents that are being used in clinical trials for diagnosing diseases that are seriously life-threatening and for which there are no effective diagnostic means, and which may benefit patients upon medical observation, after ethical review and informed consent, may be used free of charge for other patients with the same condition within the institution conducting the clinical trial of the in vitro diagnostic reagents, and their safety data may be used in the application for registration of the in vitro diagnostic reagents.

Section III Verification of Quality Management System

Article 46 The applicant shall submit information on the quality management system related to product development and production when applying for registration, and the drug supervision and management department receiving the registration application shall organize the verification of the quality management system if it is deemed necessary during the technical review of the product, and may access the original information as needed.

Article 47 The verification of the quality management system of the third class of in vitro diagnostic reagents within the territory shall be carried out by the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant is located, as notified by the device review centre of the State Bureau.

The verification of the quality management system of in vitro diagnostic reagents of the second class shall be carried out by the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government where the applicant is located.

Article 48 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall carry out verification of the quality management system in accordance with the requirements of the code of quality management for the manufacture of medical devices, focusing on whether the applicant has established a quality management system in accordance with the requirements of the code of quality management for the manufacture of medical devices, as well as the design and development, production management and quality control related to the development and production of the products.

In the verification process, the authenticity of the product for testing and clinical trial products should be verified at the same time, focusing on the design and development process records, as well as the product for testing and clinical trial products production process records.

Submitted to the self-test report, the applicant, the filer or the agency entrusted with the development process of the test capabilities, test results and other key verification.

Article 49 The provinces, autonomous regions and municipalities directly under the Central Drug Administration may carry out quality management system verification by means of information review or on-site inspection. According to the specific circumstances of the applicant, supervision and inspection, the application for registration of the product and has previously passed the verification of product production conditions and process comparison, etc., to determine whether the on-site inspection and inspection content, to avoid duplication of inspection.

Article 50 The National Bureau of Equipment Review Center of the import of Class II and Class III in vitro diagnostic reagents to carry out technical review, that it is necessary to carry out quality management system verification, notify the National Bureau of Audit and Inspection Center to carry out verification according to the relevant requirements.

Section IV Product Registration

Article 51 The applicant shall, after completing the safety and efficacy studies to support the registration of in vitro diagnostic reagents and making preparations to undergo quality management system verification, submit an application for registration of in vitro diagnostic reagents and, in accordance with the relevant requirements, submit the following registration application information to the drug supervision and management department through online registration applications and other channels.

(a) Product risk analysis information.

(b) Product technical requirements.

(d) Clinical evaluation.

(e) Instruction for use and labeling samples.

(f) Quality management system documents related to research and development.

(g) other information required to prove the safety and effectiveness of the product.

Article 52 of the drug supervision and management department received the application to review the application information, and according to the following circumstances, respectively, to deal with.

(a) the application matters belong to the administrative organ of the terms of reference, the application information is complete, meet the requirements of the form of audit, be accepted.

(b) If there are errors in the application data that can be corrected on the spot, the applicant shall be allowed to correct them on the spot.

(c) If the application information is incomplete or does not conform to the statutory form, the applicant shall be informed on the spot or within five days of the need to make corrections in full; if the applicant is not informed after the deadline, the application shall be accepted from the date of receipt of the application information.

(d) If the application matters do not fall within the competence of the administrative organ according to law, a decision of inadmissibility shall be made immediately and the applicant shall be informed to apply to the relevant administrative organ.

Drug supervision and management departments accept or reject the application for registration of in vitro diagnostic reagents, shall issue a notice of acceptance or rejection with the special seal of the administrative organ and the date indicated.

After the application for registration of in vitro diagnostic reagents is accepted, if the applicant is required to pay the fee, the applicant shall pay the fee according to the regulations. If the applicant fails to pay the fee within the prescribed period, the applicant shall be deemed to have withdrawn the application on his own initiative and the drug supervision and management department shall terminate the registration procedure.

Article 53 of the technical review process requires the applicant to correct information, the technical review body shall inform the need to correct all the content at one time. The applicant shall, within one year after receiving the notice of correction, provide additional information in accordance with the requirements of the notice of correction; after receiving the additional information, the technical review agency shall complete the technical review within the prescribed time limit.

If the applicant disagrees with the content of the notice of correction, he/she may submit written comments to the corresponding technical review body, stating the reasons and providing the corresponding technical support information.

If the applicant fails to submit additional information after the deadline, the technical review shall be terminated and the drug supervision and management department shall make the decision not to register.

Article 54 For the accepted registration application, the applicant may, before the administrative licensing decision is made, apply to the drug supervision and administration department accepting the application to withdraw the registration application and related information, and explain the reasons. If the withdrawal of the application is agreed, the drug supervision and management department terminates its registration procedure.

Review, verification, approval process found that there is suspected of concealing the true situation or providing false information and other illegal acts, according to the law, the applicant may not withdraw the registration application.

Article 55 For the accepted registration application, if there is evidence that the registration application information may be false, the drug supervision and management department may suspend the review and approval. After verification, continue the review or make the decision of not registering according to the verification conclusion.

Article 56 During the review of in vitro diagnostic reagent registration application, the technical review agency shall inform the applicant of the reasons for not passing the review, and the applicant may raise objection to the technical review agency within 15 days, and the objection shall be limited to the original application matters and the original application information. The technical review body shall make a comprehensive assessment of the applicant's objections and provide feedback to the applicant. The objection processing time shall not be counted as part of the review time limit.

Article 57 The drug supervision and administration department receiving the registration application shall, after the completion of the technical review, make a decision on whether to approve or not. To meet the requirements of safety, effectiveness and quality control, registration shall be granted and a medical device registration certificate shall be issued, and the approved product technical requirements and product specification shall be sent to the applicant in the form of an attachment. If the registration is not granted, the reasons shall be stated in writing and the applicant shall be informed of the right to apply for administrative reconsideration or to institute administrative proceedings in accordance with the law.

Medical device registration certificate is valid for five years.

Article 58 for the accepted registration application, one of the following circumstances, drug supervision and management departments to make the decision not to register, and inform the applicant.

(a) The applicant's research on the safety, efficacy and quality control of in vitro diagnostic reagents to be marketed and sold and its results cannot prove the safety, efficacy and quality control of the product.

(b) The quality management system verification is not passed, as well as the applicant refuses to accept the quality management system on-site inspection

(d) Confusing and contradictory content of the registration application data, the content of the registration application data is obviously inconsistent with the application items and cannot prove the safety, effectiveness and quality control of the product

(e) other cases of non-registration.

Article 59 of the laws, regulations, rules and regulations on the implementation of administrative licensing matters should be heard, or drug supervision and management departments believe that the need for hearing other major administrative licensing matters involving public interest, drug supervision and management departments shall be announced to the public, and hold hearings. If the application for registration of medical devices directly involves a significant relationship of interest between the applicant and others, the drug supervision and administration department shall inform the applicant and the interested party of the right to request a hearing before making the administrative licensing decision.

Article 60 For in vitro diagnostic reagents used for rare diseases, serious life-threatening diseases for which there is no effective means of diagnosis and for responding to public health events and other urgent needs, the drug supervision and management department may make a decision on conditional approval and set out in the medical device registration certificate the expiry date, the research work to be continued after listing and the time limit for completion, and other related matters.

Article 61 For in vitro diagnostic reagents with conditional approval, the registrant shall collect benefit and risk-related data after the in vitro diagnostic reagents are marketed, continuously monitor and evaluate the benefit and risk of the products, take effective measures to actively control the risk, and complete the research and submit relevant information within the specified period.

Article 62 For in vitro diagnostic reagents approved with conditions, if the registrant fails to complete the study in accordance with the requirements or fails to prove that the benefits outweigh the risks, the registrant shall promptly apply for cancellation of the medical device registration certificate, and the drug supervision and management department may cancel the medical device registration certificate in accordance with law.

Article 63 of the newly developed in vitro diagnostic reagents have not been included in the in vitro diagnostic reagent classification directory, the applicant can directly apply for the third class of in vitro diagnostic reagents product registration, but also based on the classification rules to determine the product class and apply to the State Drug Administration to confirm the class, apply for product registration or product record.

Directly apply for registration of the third class of in vitro diagnostic reagents, the State Drug Administration in accordance with the degree of risk to determine the class. Domestic in vitro diagnostic reagents identified as the second class or the first class, the applicant shall be informed to the appropriate drug supervision and management department to apply for registration or for the record.

Article 64 has been registered in vitro diagnostic reagents, its management class from the high class to adjust the low class, the medical device registration certificate continues to be valid during the validity period. If the validity period expires and needs to be renewed, the registrant shall apply for renewal of registration or filing with the corresponding drug supervision and administration department in accordance with the adjusted class six months before the expiry of the medical device registration certificate.

In vitro diagnostic reagents management class adjusted from low class to high class, the registrant shall apply for registration in accordance with the changed class to the corresponding drug supervision and management department. State Drug Administration in the management class adjustment notice should be completed to adjust the time limit to make provisions.

Article 65 medical device registration certificate and its accessories lost or destroyed, the registrant shall apply to the original issuing authority for a replacement, the original issuing authority to verify the replacement.

Article 66 In case of disputes over patent rights occurring during the examination of the registration application and after its approval, they shall be dealt with in accordance with the provisions of relevant laws and regulations.

Chapter IV Special Registration Procedures

Section I Procedures for Registration of Innovative Products

Article 67 For in vitro diagnostic reagents that meet the following requirements, the applicant may apply for the application of the innovative product registration procedure.

(a) The applicant, through its leading technological innovation activities, owns the patent right for the invention of the core technology of the product in China according to law, or has obtained the patent right for the invention in China or the right to use it through assignment according to law, and the application for the application of the innovative product registration procedure is within five years from the date of the patent grant announcement; or the application for the patent for the invention of the core technology has been made public by the patent administration department of the State Council and a search report has been issued by the Patent Search and Consulting Center of the State Intellectual Property Office, stating that the core technical solution of the product has novelty and inventiveness.

(b) The applicant has completed the preliminary research of the product and has a basically finalized product, the research process is authentic and controlled, and the research data is complete and traceable.

(c) The main working principle or mechanism of action of the product is the first of its kind in China, and the performance or safety of the product has been fundamentally improved compared with similar products, and is technically at the international leading level, and has significant clinical application value.

Article 68 For the application of innovative product registration procedures, the applicant shall, after the product is basically finalized, the State Drug Administration to submit an application for review of innovative medical devices. State Drug Administration to organize experts to review, meet the requirements, into the innovative product registration procedures.

Article 69 For the application of innovative product registration procedures for in vitro diagnostic reagents registration application, the State Drug Administration and undertake the relevant technical work of the institutions, according to their respective responsibilities to designate a person responsible for timely communication, to provide guidance.

In vitro diagnostic reagents included in the innovative product registration process, the State Bureau of device review centre and the applicant in the registration application before acceptance and the technical review process on the product development of major technical issues, major safety issues, clinical trial protocols, the summary and evaluation of the results of phase clinical trials and other issues communication.

Article 70 At the innovative product registration process of in vitro diagnostic reagents, the applicant took the initiative to request the termination or the State Drug Administration found that no longer meet the requirements of the innovative product registration process, the State Drug Administration can terminate the relevant products and inform the applicant of the innovative product registration process.

Article 71 At the innovative product registration procedures of in vitro diagnostic reagents, the applicant does not apply for registration within the specified period, no longer apply to innovative product registration procedures.

Section II Priority Registration Procedures

Article 72 In vitro diagnostic reagents that meet one of the following circumstances may apply for the application of priority registration procedures.

(a) Diagnosis of rare diseases and malignant tumors with obvious clinical advantages, diagnosis of diseases specific to the elderly and multiple diseases with no effective diagnostic means at present, dedicated to children with obvious clinical advantages, or medical devices that are in urgent clinical need and no products of the same species have been approved for registration in China.

(b) included in the national science and technology major special projects or national key research and development programs of medical devices.

(c) the State Drug Administration provisions of other priority registration procedures can be applied to medical devices.

Article 73 to apply for priority registration procedures, the applicant shall apply for registration of in vitro diagnostic reagents in the application to the State Drug Administration to apply for priority registration procedures. Belong to the first case of Article 72, the State Drug Administration to organize experts to review, in line with the priority registration procedures; belong to the second case of Article 72, the State Bureau of device review centre to review, in line with the priority registration procedures; belong to the third case of Article 72, the State Drug Administration to listen to a wide range of views, and the organization of expert evidence to determine Whether to include priority registration procedures.

Article 74 For the priority registration procedures for in vitro diagnostic reagents into the registration application, the State Drug Administration provides priority for review and approval. Provinces, autonomous regions, municipalities directly under the Central Drug Administration a well provide priority arrangements for registration quality management system verification.

National Bureau of device review centre in the priority registration procedures for medical devices included in the technical review process, should be in accordance with relevant provisions to actively communicate with the applicant, if necessary, can arrange special exchanges.

Section III emergency registration procedures

Article 75 The State Drug Administration may be required by law for emergency public health emergencies and there is no similar product listed in China, or although there is a similar product listed in China but the product supply can not meet the emergency needs of public health emergencies in vitro diagnostic reagents to implement emergency registration.

Article 76 To apply for emergency registration procedures, the applicant shall apply to the State Drug Administration for emergency registration. Meet the conditions, into the emergency registration procedures.

Article 77 For the implementation of emergency registration of in vitro diagnostic reagent registration application, the State Drug Administration share be in accordance with the unified command, early intervention, with the review, scientific approval requirements for parallel in vitro diagnostic reagent product testing, system verification, technical review and other work.

Chapter V Change of registration and renewal of registration

Section I change of registration

Article 78 The registrant shall take the initiative to conduct post-marketing research on in vitro diagnostic reagents, further confirm the safety, efficacy and quality control of in vitro diagnostic reagents, and strengthen the continuous management of listed in vitro diagnostic reagents.

For registered Class II and Class III in vitro diagnostic reagent products, if s ubstantial changes occur in their design, raw materials, production process, scope of application and method of use, which may affect the safety and effectiveness of the in vitro diagnostic reagent, the registrant shall apply to the original registration department for change of registration procedures; if other changes occur, they shall be filed with the original registration department within 30 days from the date of change.

The product name, packaging specification, main component, intended use, technical requirements of the product, product specification, production address of the imported in vitro diagnostic reagent , etc. contained in the registration certificate belong to the significant matters of change registration . The name and address of the registrant, the name and address of the Chinese agent , etc., belong to the administration matters of change registration. In the case of a change of address for the production of domestic in vitro diagnostic reagents, the registrant shall apply for filing after handling the corresponding change of production license.

In case of other changes, the registrant shall do the relevant work in accordance with the requirements of the quality management system and report to the drug supervision and management department in accordance with the provisions.

Article 79 For registered class II, class III in vitro diagnostic reagents, the core technical principles of the product, such as substantial changes, or other significant changes, a significant impact on the safety and effectiveness of the product, in essence, make a new product, does not belong to this chapter of the application for change matters, should be in accordance with the provisions of the registration application.

Article 80 for the change of registration application, the technical review body shall focus on the change part of the review, the change of the product is safe, effective, quality control to form a review opinion.

In the technical review of the change of registration application, it is considered necessary to verify the quality management system, the drug supervision and management department shall organize the verification of the quality management system.

Article 81 Change notifications of medical device and the original medical device registration certificate should be used in combination. The expiry date is the same as the original medical device registration certificate.

Section II renewal of registration

Article 82 of the medical device registration certificate expires need to renew the registration, the registrant shall, six months before the expiry of the medical device registration certificate, apply to the original registration department for renewal of registration and submit the application information in accordance with the relevant requirements.

Except for the circumstances stipulated in Article 83 of these Measures, the drug supervision and management department receiving the application for renewal of registration shall make a decision to grant the renewal before the expiry of the medical device registration certificate. If the decision is not made after the expiry date, the renewal shall be deemed to be granted.

Article 83 shall not be renewed if one of the following circumstances exists.

(a) Failure to apply for renewal of registration within the prescribed period.

(b) If the new in vitro diagnostic reagents mandatory standards or national standards issued and implemented, the application for renewal of registration of in vitro diagnostic reagents can not meet the new requirements.

(c) With the approval of the conditions of in vitro diagnostic reagents, not within the prescribed period of time to complete the medical device registration certificate contains matters.

Article 84 If approved time at renewal is within the original registration certificate validity, the renewal of registration of the registration certificate validity date for the next day of the original registration certificate expiry date; approved time is not within the original registration certificate validity date, the renewal of registration of the registration certificate validity date for the start of the approved renewal of registration date.

Article 85 In vitro diagnostic reagents change registration application, renewal of registration application acceptance and approval procedures, this chapter does not provide for, the relevant provisions of Chapter III of these measures shall apply.

Chapter VI In Vitro Diagnostic Reagents Filing

Article 86 The first class of in vitro diagnostic reagents shall be filed before production.

Article 87 For in vitro diagnostic reagents for the record, the filer shall be in accordance with the provisions of the Regulations for the Supervision and Administration of Medical Devices, submit the filing information to the drug supervision and administration department and obtain a filing number.

Article 88 For filed in vitro diagnostic reagents, if the record information table and the record of the product technical requirements have changed, the filer shall change the record to the original filing department, and submit a description of the changes and related documents. The drug supervision and management department shall post the changes in the record information.

Article 89 The management class of the filed in vitro diagnostic reagents shall be adjusted to the second or third class of in vitro diagnostic reagents, and shall apply for registration in accordance with the provisions of these Measures.

Chapter VII Working Time Limit (review time)

Article 90 The time limit stipulated in these Measures is the maximum time for the acceptance, technical review, verification and approval of in vitro diagnostic reagent registration. Special registration procedures related to the work time limit, in accordance with the relevant provisions of the special registration procedures.

The National Bureau of Equipment Review Center and other professional and technical institutions shall clarify the work procedures and time limits of their units and make them public.

Article 91 After receiving the application for registration of in vitro diagnostic reagents, the drug supervision and administration department shall forward the application information to the technical review institution within three days from the date of acceptance.

Article 92 The time limit for technical review of in vitro diagnostic reagent registration shall be implemented in accordance with the following provisions.

(a) For second class of in vitro diagnostic reagent registration application, technical review of change of registration application, renewal of registration application is 60 days, the application information after correction of the technical review is of 60 days.

(b) For third class of in vitro diagnostic reagent registration application, technical review of change of registration application, renewal of registration application is 90 days, the application information after correction of the technical review is of 60 days.

Article 93 The time limit for verification of the quality management system of the third class of in vitro diagnostic reagents within the territory shall be implemented in accordance with the following provisions.

(a) The National Bureau of Equipment Review Center shall notify the relevant provinces, autonomous regions and municipalities directly under the Central Drug Administration within 10 days after the acceptance of the application for registration of in vitro diagnostic reagents to initiate verification.

(b) Provinces, autonomous regions and municipalities directly under the Central Drug Administration shall, in principle, complete the verification within 30 days after receiving the notification of verification, and feedback the verification situation, verification results and other relevant materials to the National Bureau of Device Evaluation Center.

Article 94 The drug supervision and management department receiving the registration application shall make a decision within 20 days from the date of receipt of the review comments.

Article 95 The drug supervision and management department shall issue and deliver the relevant administrative license documents within 10 days from the date of making the decision on the approval of in vitro diagnostic reagent registration.

Article 96 Due to product characteristics and technical review, verification and other work encountered special circumstances really need to extend the time limit, the extension of the time limit shall not exceed one-half of the original time limit, approved by the medical device technical review, verification and other relevant technical institutions, the extension of the time limit by the technical institutions to inform the applicant in writing, and notify other relevant technical institutions.

Article 97 The original issuing authority shall issue a replacement medical device registration certificate within 20 days from the date of receipt of the application.

Article 98 The following time shall not be counted in the relevant work time limit.

(a) The time taken by the applicant to supplement information, rectification after verification, etc.

(b) The time taken up by delayed verification due to the applicant

(c) The time taken for external expert consultation, convening expert consultation meetings and the need for joint reviews with drug review agencies

(d) Time taken up during the suspension of the review and approval process if the review and approval process is suspended in accordance with the provisions

(d) The time taken up by the verification of the quality management system.

Article 99 The time limits specified in these Measures shall be calculated in working days.

Chapter VIII Supervision and management

Article 100 The drug supervision and management departments shall strengthen the supervision and inspection of in vitro diagnostic reagent development activities, when necessary, can provide products or services for the development of in vitro diagnostic reagents units and individuals to extend the inspection, the relevant units and individuals shall cooperate, provide relevant documents and information, shall not refuse, conceal, obstruct.

Article 101 The State Drug Administration to establish and step-by-step implementation of the unique identification system for medical devices, the applicant, the filer should be submitted in accordance with the relevant provisions of the unique identification-related information to ensure that the data is true, accurate and traceable.

Article 102 The State Drug Administration shall promptly notify the agent information to the agent's location of the province, autonomous region, municipality directly under the Central Drug Administration. Provinces, autonomous regions, municipalities directly under the Central Drug Administration to the administrative region of the agent organization to carry out daily supervision and management.

Article 103 The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the Central Government according to the medical device clinical trial institutions for the record, the organization has been filed in the administrative region of the clinical trial institutions to carry out post-filing supervision and inspection. For the newly filed medical device clinical trial institutions, shall carry out supervision and inspection within 60 days after filing.

Provinces, autonomous regions and municipalities directly under the Central Drug Administration shall organize daily supervision and inspection of medical device clinical trial institutions in their administrative regions to comply with the quality management standards for medical device clinical trials and monitor their continued compliance with the requirements. The State Drug Administration shall carry out supervision and inspection of medical device clinical trial institutions as needed.

Article 104 The drug supervision and administration department may, if deemed necessary, conduct on-site inspection of the authenticity, accuracy, completeness, standardization and traceability of clinical trials.

Article 105 The drug supervision and administration department that undertakes the filing of the first class in vitro diagnostic reagent products shall, in the post-filing supervision, order the filer to rectify the irregularities in the filing information.

Article 106 The drug supervision and administration department that fails to timely discover the systemic or regional risks in the registration and management of in vitro diagnostic reagents in its administrative region, or fails to timely eliminate the systemic or regional hidden dangers in the registration and management of in vitro diagnostic reagents in its administrative region, the higher-level drug supervision and administration department may interview the main person in charge of the lower-level drug supervision and administration department.

Chapter IX Legal Liability

Article 107 Violation of the provisions of Article 78 of these Measures, failure to file changes in accordance with the requirements, shall be ordered to rectify within a period of time; if it fails to do so, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed.

Article 108 The conduct of in vitro diagnostic reagents clinical trials that do not comply with the clinical trial quality management norms, in accordance with the "Regulations for the Supervision and Administration of Medical Devices" Article 94 shall be punished.

Article 109 medical device technical review agencies do not perform their duties in accordance with the provisions of these measures, resulting in major errors in the review, the department responsible for drug supervision and management shall order rectification, inform criticism, give a warning; if serious consequences are caused, the legal representative of the offending unit, the main person in charge, the person in charge directly responsible and other responsible personnel, shall be punished in accordance with law.

Article 110 The staff of the department responsible for the supervision and administration of drugs who violate the provisions, abuse their powers, neglect their duties or commit corruption shall be punished in accordance with law.

Chapter X By-laws

Article 111 The naming of in vitro diagnostic reagents shall follow the following principles.

The product name of in vitro diagnostic reagents generally consists of three parts. The first part: the name of the substance to be measured; the second part: the use, such as assay kits, quality control products, etc.; the third part: the method or principle, such as magnetic particle chemiluminescence immunoassay, fluorescent PCR method, fluorescent in situ hybridization method, etc. This part should be listed in parentheses.

If there are more components of the test substance or other special circumstances, the name of the indication associated with the product or other alternative names may be used.

Class I products and calibrators and quality control products are named according to their intended use.

Article 112 The registration or filing unit of in vitro diagnostic reagents shall be a single reagent or a single reagent kit, and a registration or filing unit may include different packaging specifications.

Calibration products and quality control products may be combined with in vitro diagnostic reagents for registration, or they may apply for registration separately.

Article 113 The in vitro diagnostic reagents approved for registration refer to the in vitro diagnostic reagents produced within the validity period of the medical device registration certificate and the limited contents of the medical device registration certificate.

Article 114 The independent reagent components specified in the "main components" column of the medical device registration certificate may be sold separately if they are used in the original registered products.

Article 115 In applying for registration or change of registration of in vitro diagnostic reagents, the applicant may be authorized by the owner of the master file of the medical device to quote the master file of the registered medical device. The owner or agent of the master medical device document shall handle the registration, and the relevant work procedures shall be separately stipulated.

Article 116 medical device registration certificate format by the State Drug Administration unified development.

The registration certificate number is arranged as follows

×1械注×2 ××××3 ×4 ××5 ××××6

×1 is the abbreviation of the location of the registration approval department.

Domestic Class III in vitro diagnostic reagents, imported Class II and Class III in vitro diagnostic reagents are "国".

The abbreviation of the province, autonomous region or municipality directly under the Central Government where the registration and approval department is located for the second class of in vitro diagnostic reagents within the country.

×2 is the form of registration.

The word "准" applies to in vitro diagnostic reagents domestic.

The word "进" applies to imported in vitro diagnostic reagents.

The character "許" is applicable to in vitro diagnostic reagents in Hong Kong, Macao and Taiwan.

××××3 is the year of first registration.

×4 is the product class.

××5 is the product classification code.

××××6 is the first registration stream number.

For renewal of registration, the numbers of ××××3 and ××××6 remain unchanged. If the product class is adjusted, it shall be renumbered.

Article 117 The filing number of class I products shall be arranged as follows

×1械备 ××××2 ××××3.

Where.

×1 is the abbreviation of the location of the filing department.

Imported Class I in vitro diagnostic reagents for the word "国".

Domestic Class I in-vitro diagnostic reagents are the abbreviation of the province, autonomous region or municipality directly under the Central Government where the filing department is located plus the abbreviation of the municipal administrative region where the location is set up (there is no corresponding municipal administrative region set up)

××××2 is the year of filing.

××××3 is the record running number.

Article 118 drug supervision and management departments to produce medical device registration certificate, change the registration documents electronic documents and paper documents have the same legal effect.

Article 119 according to the work needs, the State Drug Administration can be entrusted by law to the provinces, autonomous regions, municipalities directly under the Central Drug Administration or technical institutions, social organizations to undertake the specific work.

Article 120 provinces, autonomous regions, municipalities directly under the Central Drug Administration can refer to the provisions of Chapter IV of these measures to develop the administrative region of the second class in vitro diagnostic reagents special registration procedures, and reported to the State Drug Administration for the record.

Article 121 In vitro diagnostic reagents product registration fee items, fees and charges in accordance with the State Council financial and price departments in charge of the relevant provisions.

Article 122 The emergency use of in vitro diagnostic reagents of the relevant provisions, by the State Drug Administration in conjunction with the relevant departments to develop separately.

Article 123 of the domestic market does not yet have the same species of products, medical institutions according to the clinical needs of their own development, in the unit under the guidance of a licensed physician in the use of in vitro diagnostic reagents, the relevant management regulations by the State Drug Administration in conjunction with the relevant departments.

Article 124 Hong Kong, Macao and Taiwan in vitro diagnostic reagents registration, filing, with reference to imported in vitro diagnostic reagents for.

Article 125 These measures shall come into force on October 1, 202 1. The former State Food and Drug Administration Order No. 5 announced the "in vitro diagnostic reagents registration management measures" (30 July 2014) shall be repealed at the same time

After product approval activities in China including post market

Sun, 22 Jan 2023 18:09:22 GMT

After product approval activities in China, not only in term of post market

Active and reactive regulatory action

Tag: Overseas inspection, serious adverse event, recall, Chinese IFU, Chinese label, UDI, Medical insurance medical consumables code, Chinese vigilance, serious adverse event, periodic risk evaluation report, annual QM report, NMPA inspection, Change of design, material, critical components, critical production process, quality control, Central procurement, legal representative = Chinese agent, post market surveillance

Registration related after approval activities

After successful product approval, legal manufacturers should finalize Chinese labelling, register Unique Device Identifier (UDI) and Medical insurance medical consumables code .

There are 3 Chinese identifications which are unique if you wish to place medical device in China.

1. Chinese Labelling are Chinese IFU and Chinese label meant. After product approval, NMPA issues a certification number on certificate which should be revised in submitted draft of Chinese IFU and Chinese label. Special for Chinese label is production date which should not be older than approval date.

2. Unique Device Identifier (UDI) is a new tracing number on medical device and packaging which is in a rapid international implementation period. At the moment only UDI-DI and attributes related to approved medical device (class III and partly class II) shall be listed after approval in UDI-database in China by manufacturer’s legal representative.

3. Medical insurance medical consumables co de is unique Chinese in insurance system. The Chinese legal representative should register UDI and Medical insurance medical consumables code in insurance databases .

Actually we strongly recommend backing up new electronic product certificate with annex Product Technical Requirement . (PTR). Please prove again PTR which is finalised during the Chinese type testing. These parameters on PTR are not only important during the registration, but also for tender at sales and should be frozen in design for approved medical device.

Any significant change to these parameters triggers change registration . Normally this approved medical device is a country variant which might be different than the home country variant . In QM system if this variant is chosen to be sold in China, only components which are described or not in conflict with registration dossier should be assembled and produced.

After pre-market registration begins potential inspection by health institutions and post-market activities by manufacturers

After distribution of medical device to end user in China, it begins automatically the post market activities in the whole supplier chain which should be described in QM-procedure and recorded compliant to Chinese requirements.

The Chinese authority has the right to inspect legal manufacturers, Chinese agent of foreign manufacturers, all levels of distributors and end users (normally hospitals) , which can be seen as a kind of reactive post-market activities . Even the customs for foreign manufacturers , local health authorities, hospitals could check in Chinese market placed medical device and IVD.

The legal manufacturer himself should actively collect all product data to fulfil their post-market activities (=active post-market activities) as complaint, reporting of adverse event and recalls, periodic risk evaluation report, annual report of quality management.

1. Potential reactive inspection

Fortunately the manufacturers for medical device produced outside China don’t need pass the Chinese GMP-inspection. Normally at product registration a valid ISO 13485 certificate is the best evidence for guaranteed QM-requirement.

Unfortunately after product approval, Chinese authority may audit all stakeholders in supply chain, from Chinese agent, distributor, hos pitals, often ignored is also overseas inspection of foreign factory. Normally there is s tandard inspection of quality system. Besides it, in term of sample inspection the authority in China can also send the subject device to certified lab to test compliant to design.

Be aware that in the Chinese life cycle at supply chain, authority has each year focused products to be inspected and applicable testing items in Chinese standards.

Pay attention under general inspection to guideline of quality management system, however there is additional guideline for IVD, implant and sterile medical device.

Mainly it applied only approved class II and III medical device. The scope of inspection by Chinese authority is similar to ISO 13485:

• Organisation and personal

• plant, facilities, equipment

• Document management

• Design and development

• Purchase

• Production

• Quality Control

After pandemic NMPA starts overseas inspection personally as of 2024.

2. Serious adverse event and recall

The subjects to submit report to Chinese authority are serious adverse event and recall (over the world).

To record on manufacturers own quality management are typically: normal adverse event, customer complaints and unsolicited user feedback.

It means only serious injuries are obligatorily to report. It makes reporting system complicated that more and more health users register for an event of adverse event in central database without communicating with legal manufacturers. So the sum of analysed SAE is

active SAE in China and active SAE international by overseas manufacturers

active SAE by Chinese agent and distributor

reactive correct SAE and incorrect adverse events or complaints by health users

Vigilance

The process of collection, reporting, investigation, analysis, evaluation and control of adverse events

Recall:

Level 1 recall: the use of the medical device may or has caused serious health hazards;

Level 2 recall: the use of the medical device may or has caused temporary or reversible health hazards;

Level 3 recall: The use of the medical device is less likely to cause harm but still needs to be recalled.

Timeline to register recall to authority:

Level 1 recall: 1 d

Level 2 recall: 3 d

Level 1 recall: 7 d

Serious injury

1. Life-threatening;

2. Cause permanent damage to body functions or permanent damage to body structures;

3. Medical measures must be taken to avoid the above permanent injury or damage.

Timeline to register SAE to authority:

3 . Periodic Risk Evaluation Report

It is quasi Chinese PSUR. It is annually to submit in the first 5 years Chinese lifecycle after approval.

The authority provides a relative clear template for manufacturers.

It contains worldwide marketing history, vigilance summary, literature evaluation and risk analysis related to adverse effects, adverse events and recalls.

Have a close look at our template .

4. Annual QM report (new in 2023)

Perhaps the Chinese authority can`t oversea foreign manufacturers in the quality and production aspects, perhaps Chinese authority learns from other markets there is also QM-reports regularly.

"Invented" is annual self-examination report of medical device quality management system as of 2023 .

It applies only to approved medical devices in China, one report for all products.

For foreign manufacturers, Chinese agent is responsible to submit this annual report every year before April . Besides the basic info of approved medical device, following chapters are needed:

· Change of design, material, critical components, critical production process, quality control

· Adverse events and recalls

· Non-conforming devices

· All kinds of national inspections

· Central procurement

· Penalties

· Internal audit

Contact us to have a bilingual annual report. One is for your back up. The other can be used by your local representative ready to submit. We have record time to fill the template.

Outlook

Compared to European post market surveillance , Chinese authority is still in a generous post market manner to stipulate the inspection and reports.

There is no annual certification inspection by notified body in China. No post markets surveillance procedure must be revised and monitored in a high professional frequence as in Europe. There are no special efforts collecting generous real world clinical data to integrate to Chinese clinical evaluation which is only once to edit at next product registration.

We illustrate below the post market activities with assigned roles. Due to complex regulations and language barrier the efforts to post market are unpredictable. Often the local distributor ha s limited regulatory knowledge and other interest than active monitoring in Chinese marked placed medical device.

Contact us to have an adjusted post market procedure in full compliance to Chinese requirements. We can also take over of communication with your distributor for an efficient post market results.

How to handle unexpected inspection in all supply chain even overseas manufacturers and productions site? How to monitor QM-compliance of authorised Chinese production and Chinese distributor?

We are always here to accompany or execute inspection with your need.

Top 10 news in Chinese medical device market in 2022

Tue, 27 Dec 2022 17:43:33 GMT

Top 10 news in Chinese medical device (IVD) market in 2022

Tags: Legislative of medical device in China, 14th Five-year plan, public centralized procurement, National Medical Products Administration (NMPA), technical documentation, type testing, class I medical device, GB 9706 standards, imported medical device, acceptance- and technical review, basic principles of medical device safety and performance, medical software, QM inspection, annual QM report, UDI of class II medical device, Chinese obligatory standards, clinical evaluation and clinical study

Policy in Chinese market

1. 14th Five-year plan for the medical device and pharmaceutical industry and protectionism at public procurement of imported goods

14th five-year plan (till 2025) of ManTech branch was published to highlight the domestic development with ambitious goal: IVD (point of care testing), radiation therapy device, life and monitoring supporting device, Chinese medicine, maternal and child health, health rehabilitation and active intervention device.

In “ Guidance for Reviewing Imported Products in Government Procurement ” it lists 137 medical devices which must be supplied from domestic manufacturers, 12 medical devices covered by 75% domestic manufacturers, 24 medical devices covered by 50% domestic manufacturers and 5 medical devices covered by 25% domestic manufacturers. More and more provinces preferred only local medical devices at tender and need expert opinion for needed oversea medical devices. The government in parallel releases also welcome regulation of acceleration of approval of foreign medical device if it will be produced in China. Many global players start to transfer the production in China or use local many original equipment manufacturers.

Contact us to have a tactic market analysis of your existing approved and planned medical device in China. There are several intteligent options to make actions to keep the Chinese market share on top.

Registration

2. Requirements and checklist of technical documentation of medical device

There is a new notification “ requirements for review of medical device registration dossier ” with valuable annexes ( initial- change registration, renewal, exempted clinical comparison, clinical evaluation and clinical trial of medical device and IVD ) confusing readers in term of technical documentation at registration. It is primary for authority’s reviewer as checklist at acceptance review after dossier submitted. However, manufactures could use it as checklist as well before submitting dossier officially.

The hurdle of acceptance review at CMDE is arising. Some manufacturers pass the review by providing twice the deficiency replies. A few manufactures even fail and disqualify after extensive preparation at this new checking point.

The requirements of registration dossier with DETAILS are backing in 2021 . This is most important instruction for manufacturers to prepare technical documentation at early stage.

3. Notification of class I medical device and IVD in China

The art of register or list class I medical device can be called also notification. It bears back there that authority has an extreme fast review procedure due to low risk of class I and no critical documentation to prove. In the new notification there is an application template, a new format of electronic notification (replacing paper notification), explanation of application template . The unnecessary clinical evaluation and risk management are removed . The only documents to submit are:

· 1. Associated files

· 2. Product technical requirements

· 3. Testing report

· 4. Chinese User manual and label of the smallest sales unit

· 5. Manufacturing information

· 6. Declaration of Conformity

4. GB 9706 series standards soon arriving transition deadline of validity (May, 2023)

The authority was clever to permit 3 years transition period for most GB 9706 series standards. However the capability and the capacity of labs to test the device which need time to certify the standards were extremely ignored. As of Dec. 2022 there are only 59 certified labs qualified for GB 9706.1-2020 and YY 9706.102-2021 (IEC 60601-1:2012, Medical electrical equipment—Part 1: General requirements for safety and IEC 60601-1-2:2007, Medical electrical equipment－Part 1-2: General requirements for safety－Collateral standards：Electromagnetic compatibility－Requirements and tests ). The legal manufacturer could begin to apply for testing active medical device compliant to GB 9706 series standards just this year.

So it is unavoidable that many manufacturers can’t pass the deadline of validity of GB 9706 series standards prior May in 2023. So far there are only speculations how authority handle the market entry gap in term of missing type testing of GB 9706 series standards. We estimate:

· Authority postpones the deadline of GB 9706 series standards for x years

· The medical device can be compliant to GB 9706 series standards in prior to next renewal (every 5 years)

· The medical device new produced as of 2023.05.01 must be developed according to GB 9706 series standards; test by certified labs can be catched up.

· Authority leaves back doors open that some critical medical devices are in stringent inspection of these GB 9706 series standards; no clear implementation date for obligatory change registration.

The obligatory Chinese GB-standards trigger change registration . We suggest the legal manufacturers to start to test their medical devices conform to GB 9706 series standards ASAP.

Ask us to accompany the type testing . We can rapidly prepare the application material for Chinese labs together with your research department, know the efficient Chinese labs to execute the testing with short period and send trained engineer to handle the testing unit onsite.

If you even still don’t know which GB 9706 series – or other obligatory standards [4] apply to your products contact us to have a gap analysis of Chinese standards .

5. Revised basic principles of medical device safety and performance

Are basic principles of medical device safety and performance in China different? Not really, it has IMDRF and Chinese elements. Manufacturers can reference international standards and in most parts of principles only Chinese standards. By filling the template of basic principles of medical device safety and performance, t he document name in exact chapter position derived from registration dossier must be given, so the reviewer can target-oriented search evidencing documents.

Contact us to know the gap to your country specific basic principles of medical device safety and performance. The difference must be payed attention and implemented as early stage of R&D process .

6. Chinese clinical evaluation and clinical trial of medical device and IVD

In a separate bundle regulation, Chinese authority provides exact clinical pathways for 7 most common product groups among 22. It should leverage manufacturers to choose correct clinical evidence and reviewers to prove clinical data. Please don’t forget to understand and follow the basic regulations of clinical evaluation and clinical trial which were published in 2021.

The requirement of Chinese clinical evaluation and clinical trial is approaching in a predetermined set of rules. In a notification of clinical trial with 6 annexes there are clear templates which manufactures have to follow.

· 1. Medical device clinical trial protocol template

· 2. Medical device clinical trial report template

· 3. Template of clinical trial protocol for in vitro diagnostic reagents

· 4. Template of clinical trial report for in vitro diagnostic reagents

· 5. Template for Serious Adverse Event Reporting Form for Clinical Trials of Medical Devices/In vitro Diagnostic Reagents

· 6. Catalog of Basic Documents for Clinical Trials of Medical Devices/In vitro Diagnostic Reagents

7. Strengthened requirements of medical software

With increasing registration of medical device software, Chinese authority revised the most important guidance of software with best practise:

· Medical Device Software Registration

· Medical device network security registration

· Artificial Intelligence Medical Devices

In general the software requirements are specified described in new guidance of “Medical Device Software Registration”. The software file is typical documentations at technical review which lacks full compliance. The GB GB/T 25000.51-2016 “Systems and software engineering -- Systems and software Quality Requirements and Evaluation (SQuaRE) -- Part 51: Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing ” which is for QM of standalone software is unfortunately required at guidance as internal test for embedded software as well.

The Chinese market is opening to new medical software with artificial intelligence slowly. The understanding of software requirements of quality and validation is still in a developing level. The lacking equivalent device makes it complex to classify medical device to a moderate classification (so far only 9 mean product codes under 21-xx-xx) and very often impossible to compare subject software to equivalent software with same intended use at clinical evaluation.

Still Chinese market is so attractive for manufacturers of medical software on the one site because of not that fancy professional regulations and on the other site meaningful due to so many valuable information collected by huge Chinese population.

Quality Management

8. Measure for the Supervision and Administration of Medical Device Production and Guideline for Inspection of Quality Management System for Medical Device Registration

Measure for the Supervision and Administration of Medical Device Production is highest law stipulating the framework of quality management in China . It is primary essential for the manufacturers who has production site in China. It means that it is so far rare that Chinese authority goes abroad to inspect factory. The new contents at Supervision and Administration of QM are to define the relation between legal manufacturers and increasingly outsourced production party, introduction of 4 kinds of QM-reports and strength of penalties upon non-compliance.

Guideline for Inspection of Quality Management System for Medical Device Registration regulates what are the QM-requirements of class II and III medical device. Unlike abstract ISO 13485:2016 Medical devices-Quality management systems-Requirements for regulatory purposes, this guideline comprises 73 QM-requirements to be checked (32 main- and 41 minor requirements). These are transparent requirements which are proved by authority to pass the GMP-inspections.

9. Annual self-examination report of medical device quality management system

Perhaps the Chinese authority can`t oversea foreign manufacturers in the q uality and production aspects, perhaps Chinese authority learns from other markets there is also QM-reports regularly. Invented is annual self-examination report of medical device quality management system. It applies only to approved medical devices in China, one report for all products.

For foreign manufacturers , Chinese agent is responsible to submit this annual report every year before April. Besides the basic info of approved medical device, following chapters are needed:

· Change of design, material, critical components, quality control

· Adverse events and recalls

· Non-conforming devices

· All kinds of national inspections

· Central procurement

· Penalties

· Internal audit

Labelling

10. UDI implementation of class II medical device

The rollout of class II medical device is in draft.

As of 01, 06, 2024, some class II medical devices in third series which will be manufactured after this date must bear UDI.

As of 01, 06, 2024, UDI-DI on label of the smallest sales unit among these medical devices must be provided at initial -, change registration and renewal.

As of 01, 06, 2024, the info of UDI of these medical devices must be registered at central UDI database. It should be consistent with UDI at data base “National Medical Insurance Administration”. Manufacturers have to supplement medical insurance classification and code at UDI data base.

See our blog to know whether your class II medical device is included in the third UDI-rollout in China.

New issued Guidance of medical device and IVD up to date

Sat, 24 Dec 2022 14:13:22 GMT

Chinese guidance of medical deivce und IVD (2021- up to date)

In General

We will trace all issued general and product specific guidance of medical device and IVD with analysis as of 2021. In additional to general and product specific standards in parallel, it helps you as legal manufacturers to prepare upcoming registration of medical device and IVD with full compliance.

Why is guidance important

The new issued guidance incorporates essential requirements of submission dossier . Oft are details of performance parameters, risk management, type testing, product technical requirement, clinical evaluation, clinical study, labelling, verification and validation specified. It is wise to fulfil these new additional requirements to avoid deficiency in the next product registration.

Unlike standards, guidance of medical device and IVD has no transition period. It means when draft is to published, legal manufacturers should be aware of new requirements. Once the guidance is issued, the new requirements have to be fulfilled in the upcoming and next registration.

Guidance as a glance ( 2021- 2022 )

Guidance for Registration Review of Epstein-Barr Virus Antibody Detection Reagents

Guidance for Registration Review of Quality Control Products—Research on Value Assignment of Quality Control Products

In vitro diagnostic reagents reference interval determination registration review Guidance

Qualitative detection in vitro diagnostic reagents analytical performance evaluation registration review Guidance

Hepatitis E virus IgM/IgG antibody detection reagent registration review Guidance

Guidance for preclinical registration review of human immunodeficiency virus antigen antibody detection reagents

Issued date: 2022-09-28

Oral retainer registration review Guidance

Guidance for registration review of fungal (1-3)-β-D glucan assay reagents

Guidance for product registration review of dental root canal lubricant cleaner

Guidance for registration review of medical center oxygen supply system

Dental blasting powder registration review Guidance

Guidance for registration review of fecal calprotectin detection reagents

Guidance for registration review of medical sterile ultrasonic gel

Guidance for registration review of medical infrared forehead thermometers

Guidance for Registry Review of Disposable Surgical Caps

Guidance for registration review of cyclosporine and tacrolimus detection reagents

Guidance for registration review of heart-type fatty acid binding protein assay reagents

Acid Oxidation Potential Water Generator Registration Review Guidance

Guidance for Registration Review of Medical Protective Clothing Products

Guidance for the registration review of high-sensitivity cardiac troponin detection reagents

Guidance for Registration Review of Shortwave Therapeutic Devices

Guidance for Registration Review of Medical Air Compressor Units

Guidance for registration review of non-chronic wound dressings

Guidance for product registration review of scar repair materials

Guidance for registration review of single-use EEG electrodes

Guidance for Registration Review of Estradiol Detection Reagents

Guidance for the registration review of prealbumin detection reagents

Guidance for Registration Review of Glycated Hemoglobin Analyzers

Guidance for Registration Review of Vascular Clip Products

Guidance for Product Registration Review of Electroacupuncture Therapy Devices

Guidance for Registration Review of Disposable Sterile Urine Drainage Bags

Guidance for Registration Review of Fibrin Monomer Determination Reagents

Guidance for Product Registration Review of Disposable Incision Protectors

Issued date: 2022-09-15

Guidance for Registration Review of Analytical Performance Evaluation of Quantitative Detection In Vitro Diagnostic Reagents

Issued date: 2022-08-26

Guidance for Registration Review of Clinical Trials of Original Companion Diagnostic Reagents Developed Simultaneously with Antineoplastic Drugs

Issued date: 2022-06-28

PD-L1 Detection Reagent Clinical Trials—Guidance for Registration Review of Results Reproducibility Studies

Issued date: 27.06.2022

Guidance for the registration review of fundus image-assisted diagnosis software for diabetic retinopathy

Issued date: 02.06.2022

Guidance for registration review of CT image-assisted detection software for pulmonary nodules

Issued date: 26.05.2022

Guidance for Registration Review of Extracorporeal Membrane Oxygenation (ECMO) Devices

Issued date: 28.04.2022

Guidelines for the registration review of high-strength and toughness pure titanium orthopaedic internal fixation implants

Issued date: 01.04.2022

Guidance for Stability Studies of Passive Implantable Medical Devices

Guidance for registration and review of Intravascular Guide Wires Guidelines

Issued date: 16.03.2022

Guidance for registration and review of Ophthalmic Laser Photocoagulation Machines

Issued date: 09.03.2022

Guidance for registration and review of Laser Selective Melting Metal Materials for Additive Manufacturing of Prosthodontics

Issued date: 03.03.2022

Guidance for registration and review of Additively Manufactured Polyetheretherketone Implants

Issued date: 02.03.2022

Guidance for research on uniformity of physical and chemical properties of additively manufactured metal implants

Issued date: 28.02.2022

Guidance for registration and review of Positron Emission/X-ray Computed Tomography Systems (Special for Digital Technology) Guidance for registration and review of Biosafety Cabinet

Guidance for registration and review of Additively Manufactured Polyetheretherketone Implants

Issued date: 19.01.2022

Guidance for registration Review of drug-device combination products focusing on the role of medical devices

Guidance for registration and review of Intraocular Lens

Guidance for registration and review of Single-Use Endoscopic Needles

Guidance for registration and review of Microcatheter

Guidance for registration and review of Biodegradable Magnesium Metal Orthopedic Implants

Guidance for registration and review of metal bone plate internal fixation system

Guidance for registration and review of Disposable High Pressure Contrast Syringe and Accessories

Issued date: 17.01.2022

1. Guidance for registration and review of fluorescence immunochromatographic analyzers

2. Guidance for registration and review of net atomizers

3. Guidance for registration and review of medical diagnostic X-ray equipment including pediatric applications

4. Guidance for registration and review of ultrasound transcranial Doppler blood flow analyzers

5. Guidance for registration and review of hydrogen peroxide sterilizers

6. Guidance for registration and review of blue light therapy devices for newborns

7. Guidance for registration and review of root canal preparation machines

8. Guidance for registration and review of blood cell analyzers

9. Guidance for registration and review of gait training equipment

10. Guidance for registration and review of pepsinogen I/II detection reagents

11. Guidance for registration and review of Prothrombin time/activated partial thromboplastin time/thrombin time/fibrinogen detection reagent

12. Guidance for registration and review of Retinol binding protein assay kit (immunoturbidimetric method)

13. Guidance for registration and review of folic acid determination reagents

14. Guidance for registration and review of anti-Mullerian hormone determination reagents
Issued date: 28.12.2021

1. Guidance for registration and review of Extracorporeal membrane oxygenation (ECMO) circulation package

2. Guidance for registration and review of single-use abdominal puncture devices

3. Guidance for registration and review of ossicle prosthesis products

4. Guidance for registration and review of artificial ligaments

5. Guidance for registration and review of the pectus excavatum system product"

Issued date: 20.12.2021

1. Guidance for registration and review of passive surgical devices under arthroscopy

2. Guidance for registration and review of single-use ureteral introducer sheaths

3. Guidance for registration and review of orthodontic filaments

4. Guidance for registration and review of single-use minimally invasive fascial closure devices

5. Guidance for registration and review of anesthesia mask products

6. Guidance for registration and review of non-vascular luminal guidewire products

7. Guidance for registration and review of circumcision staplers

8. Guidance for registration and review of dental desensitizers
Issued date: 16.12.2021

Guidance for registration and review of Nerve and Cardiovascular Surgical Instruments-Knives, Scissors and Needles

Issued date: 01.12.2021

Guidance for registration and review of Medical Device Animal Experimental Research

issued date 27.09.2021

There are two guidances regarding animal test: I Decision-making principle; II Test design, implementation quality assurance . These guidelines are applicable to deciding whether medical devices need to be tested in vivo on live animals, excluding research conducted on non-living animals, isolated tissues or organs. In the first guidance the product code for potencial ainmal testing is given as example .

Guidance for registration and review of Registration of Mammary X-ray System

issued date 27.09.2021

Product code: 06-01-03 and 06-05-12

This guidance is applicable to the mammography machine with product code 06-01-03 and its attached product code 06-05-12 stereo positioning device for mammography. In annex there are valuable examples of
1. Product composition
2. Risk management
3. Product technical requirements template
4. Configuration table
5. Change product component inspection standards
6. Requirements for clinical evaluation through medical devices of the same variety
7. Clinical trial requirements
8. List of terms and abbreviations

Guidance for registration and review of the registration of vision screeners

It applies to clinical evaluation of common MR systems as well as MR components of multi-modal systems such as PET/MR systems. Intraoperative MR systems, special MR systems suitable for special parts such as breast/limbs, and special MR systems suitable for specific populations such as pediatrics can also be clinically evaluated according to the applicable requirements of this guidance. It does not apply to the clinical evaluation of MR systems with magnetic field strength greater than 3.0T, software parts with auxiliary decision-making functions, quantitative imaging and magnetic resonance spectroscopy imaging technologies

Guidance for registration and review of registration of cryptococcal capsular polysaccharide antigen detection reagents

Issued date 19.01.2021

IVD.

It applies to the use of enzyme-linked immunosorbent assay, latex agglutination test and lateral immunochromatography based on the principle of antigen-antibody reaction, for the detection of human samples derived from serum and/or plasma and/or whole blood and/or cerebrospinal fluid. Reagent for in vitro qualitative detection of cryptococcal capsular polysaccharide antigen.

Guidance for registration and review of registration of genetic deafness-related gene mutation detection reagents

Issued date 19.01.2021

IVD.

Guidance for registration and review of registration of Mycoplasma pneumoniae IgM/IgG antibody detection reagents

Issued date 19.01.2021

IVD.

It applies to reagents for the in vitro qualitative detection of Mycoplasma pneumoniae IgM and/or IgG antibodies in human serum, plasma or whole blood by immunochromatography, enzyme-linked immunoassay or chemiluminescence method.

Guidance for registration and review of clinical evaluation of the same type of imaging ultrasound diagnostic equipment

issued date 19.01.2021

Product code 06-07-xx

It applies clinical evaluation of Imaging Ultrasound Diagnostic Equipment.

Contact us

The original guidance is all in Chinese. Write us an email to get the link and the English translation with corresponding cost if needed.

If you need all regulations matching your product code. Upon request we can provide you periodic regulatory update in service as below in customer need with precise gap analysis:

Scope (product code with description)
Key points of registration review

device description
product technical requirement
risk management with typical hazards
biocompatibility
sterilization
raw material control
shelf life, packaging
clinical evaluation and study,
labelling
New : quality management system document

How to register medical software in China?

Mon, 23 May 2022 19:17:25 GMT

How to register medical software in China?

The general “stand of the art” of medical software in China is in a developing stage. Many manufacturers misuses medical software in the health field and Chinese NMPA is struggling to align with internal regulation of medical device to surveil this new arising market which will impact Chinese medical device market in the next centuries.

Let’s narrow the definition firstly of medical software to software as medical device (SaMD). Excluded is embedded software in medical device system which is regulated through solid software guidance in 2022 to be covered by software file. In this guidance, SaMD is also mentioned and defined as:

“Software that has one or more medical purposes/uses, can complete its intended use without medical device hardware, and run on a general-purpose computing platform. The general computing platform meets the safety requirements of information technology equipment (including electromagnetic compatibility)”

This topic of SaMD is quite complex. We give some hint to register SaMD in China. So far the challenge to mark the SaMD in China is intransparent due to missing knowledge at authority, testing institutions and SaMD manufacturers und its usage at hospitals or at home. Still China remains an attractive market to enter earlier due to medical environment potential and huge populations which live already in artificial intelligence life.

1. Determine classification of medical software

As at FDA there is a product code system in China which determines the product classification. All medical software belongs to 21-xx-xx main groups. So far there are only roughly 6 subgroups:

· 21-01 Treatment Planning Software

· 21-02 Image processing software

· 21-03 Data processing software

· 21-04 Decision Support Software

· 21-05 In vitro diagnostic software

· 21-06 Others

Including the last 2 digits among 6 product code there are 51 precise product code of medical device. For innovative SaMD which has no equivalent product to compare in China, there is a green pathway of registration with prerequisite that the medical device has a Chinese patent.

The first task for manufacturers is to match product code and classification depending on intended use of subject medical device.

2. Create registration tactic

Regulatory requirements are following and guiding to which SaMD manufacturer should develop SaMD compliant. The technical dossier to submit is to adapt to Chinese regulation of software.

We list the most important regulations for SaMD below:

Regulation

Guidance for Medical Device Software Registration Review, 2022
Guidance for Medical Device Cybersecurity Registration Review, 2022
Guidance for Registration and Review of Artificial Intelligence Medical Devices, 2022
Guidance for Technical Review of Mobile Medical Device Registration, 2017

QM-related

Guidance for On-Site Inspection of Independent Software of Good Manufacturing Practice for Medical Devices, 2020

Standard

YY/T 0664-2020 Medical device software—Software life cycle processes

"As IEC 62304:2015"

YY/T 1406.1-2016 Medical Device Software- Part1: Guidance on the application of ISO 14971 to medical device software

"As IEC/TR 80002-1:2009"

GB/T 25000.51-2016 Systems and software engineering—Systems and software Quality Requirements and Evaluation (SQuaRE)—Part 51：Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing

"As ISO/IEC 25051:2014"

GB 4943.1-2011 Information technology equipment—Safety—Part 1: General requirements

"As IEC 60950-1:2005 "

*Please refer to product specific standards as in guidance of Software Registration Review and Cybersecurity Registration Review as well in product specific guidance.

Belonging to registration plan are always the timeline of registration, resources plan (budget, personal) and competitor analysis.

3. Make gap analysis of technical dossier

At the end of evaluation of registration of SaMD, a gap analysis is created to the current technical documentation of SaMD. Upon the gap the actions should be initiated in a project: prepare internal testing, type testing in China, draft IFU and perhaps Chinese interface language, plan of clinical evaluation or clinical study .

4. Select a Chinese representative for registration

For foreign manufacturers you might need a Chinese representative (Chinse agent) to submit the dossier to NMPA if you don’t have a Chinese entity. However foreign manufacturers remain as marketing authorised holder in China which might be different than in Japan.

It could be nice to have a reliable Chinese distributor however not typical late after product approval. During the testing in China, a person e.g. as future Chinese distributor who is familiar to your SaMD might be useful to show how the software works to testing engineers. If medical software had cloud service to save data of patient, only a Chinese distributor could run this cloud. No data of patient goes abroad.

5. Start compilation of technical dossier and type testing

All technical dossiers should be submitted electronically in Chinese . Based on general and special Chinese requirements of software, the dossier would be edited, revised, proved and released . At the same time manufacturers has to start type testing as early as possible. This is unique Chinese other than registration in home country where SaMD is not exanimated by external lab. The functional parameters as stated in a tempate at software guidance will be tested conform to Chinese standard.

6. Submit electronic technical dossier and acceptance – and technical review at NMPA

Prior to submission, foreign manufacturer has to notarise some original certificates and statements and sign all English documented as reference. After submission of technical dossier, the manufacturers may get an acceptance notification in 5 days if some documents in dossier are missing. After acceptance of dossier, NMPA begins technical review after which manufacturers have one year time to address technical deficiency till final approval.

7. Distribution medical device to users, UDI-Registration, Post-market activities

In China manufactures don’t need to register themselves after product approval. You get a product certificate of SaMD valid for next 5 years. It is better to register UDI for class III SaMD immediately after product approval. As of this date you may distribute SaMD in Chinese market. Typically there is some obligatory for manufacturers to monitor the product in term of adverse events, recalls, periodic risk evaluation report, annual QM report.

8. Next registration of new significant software release

SaMD is also under change assessment . The typical significant changes to trigger next change registration are significant cybersercurity and release of next main software version which normally adjusted by the first letter of software version depending on naming of software version. Otherwise manufactures have to renewal their certificate every 5 years.

Contact us to have a professional registration evaluation and marketing strategy of your SaMD. It is way wise to kick a complex registration project off with risk-based approach with actions already analysed and prepared.

Related international regulation of Software as a Medical Device

IMDRF , Software as a Medical Device (SaMD)

FDA , Content of Premarket Submissions for Device Software Functions , new in 2023

Health Canada, Guidance Document: Software as a Medical Device (SaMD ) )

UK, Medical device stand-alone software including apps (including IVDMDs)

Chinese regulations of post market surveillance

Sun, 08 Aug 2021 12:17:34 GMT

Chinese regulations of post market surveillance

Provisions for Medical Device Adverse Event Monitoring and Re-evaluation

(SAMR Decree No.1)

The Provisions for Medical Device Adverse Event Monitoring and Re-evaluation, approved by the State Administration for Market Regulation and the National Health Commission, is hereby promulgatedand shall be put into force as of January 1, 2019.

Resource

Chapter I General Provisions

Article 1 In order to strengthen monitoring and re-evaluation of medical device adverse events, promptly and effectively control post-market risks of medical devices and ensure human health and life safety, the Provisions is hereby formulated in accordance with Regulations for the Supervision and Administration of Medical Devices.

Article 2 The Provisions applies to the monitoring, re-evaluation, supervision and administration of medical device adverse events within the territory of the People's Republic of China.

Article 3 Medical device marketing authorization holders (hereinafter referred to as MAHs) shall possess the capacities of quality management and corresponding responsibilities to ensure that the medical devices are safe and effective, establish medical device adverse event monitoring system and directly report medical device adverse events to medical device adverse event monitoring agencies (hereinafter referred to as monitoring agencies). Distributing enterprises and user facility of medical device authorized by MAHs shall report medical device adverse events to MAHs and monitoring agencies.

MAHs shall evaluate the identified adverse events, improve the product quality based on evaluation results and report the evaluation results and measures for quality assurance to monitoring agencies; where review and approval by the original registration authority is required, application shall be submitted in accordance with the regulations.

Agents designated by overseas MAHs shall undertake adverse event monitoring of the imported medical devices sold within the territory of China and cooperate with overseas MAHs to fulfill the obligation of re-evaluation.

Article 4 The terms in the Provisions are defined as follows:

(I) MAHs of medical device refer to the holders of medical device registration certificate and filing certificate, namely, medical device registrants and filing persons.

(II) Medical device adverse event refers any harmful event occurred while using marketed medical devices under their normal usage that causes, or is likely to cause, harm to human body.

(III) Serious damage is defined as the damage that one of the following situations is met:

1. Life threatening;

2. Causing permanent harms to body function or injuries to body structure;

3. Medical measures are required to avoid the above-mentioned permanent harms and injuries.

(IV) Group adverse event of medical device refers to the events occurred by the same medical device during its use that causes harm or threat for the health or life safety of a certain amount of population within a relatively concentrated time and area.

(V) Medical device adverse event monitoring refers to the process of collection, reporting, investigation, analysis, evaluation and control of medical device adverse event.

(VI) Intensive surveillance for medical device refers to the periodic monitoring activities which are performed actively for studying the post-market risks, characteristics, severity, and incidence of some variety or product.

(VII) Medical device re-evaluation refers to the process of re-evaluating the safety and effectiveness of medical devices registered/filed and sold on the market and taking corresponding measures.

Article 5 National Medical Products Administration (hereinafter referred to as the NMPA) shall establish the National Medical Device Adverse Event Monitoring Information System and strengthen the construction of medical device adverse event monitoring information network and database.

Monitoring agencies designated by the NMPA (hereinafter referred to as national monitoring agencies) shall be responsible for unified management of all the information of medical device adverse events collected and provide feedback of relevant monitoring information of medical device adverse events to relevant monitoring agencies, MAHs, distributing enterprises or user facilities.

Monitoring information related to product use risks shall be reported to Health Administrative Departments.

Article 6 Drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall establish and improve medical device adverse event monitoring system, be equipped with corresponding monitoring agencies and personnel and carry out medical device adverse event monitoring.

Article 7 Where units and individuals discover any medical device adverse event, they have the right to report to authorities of drug supervision and administration (hereinafter referred to as drug regulatory departments) or monitoring agencies.

Chapter II Responsibilities and Obligations

Article 8 The NMPA shall be responsible for the supervision and administration of medical device adverse event monitoring and re-evaluation nationwide, organize the investigation and handling of group adverse events of medical device that has great influence nationwide and causes severe injuries or death and other serious consequences jointly with the Health Administrative Departments of the State Council, and take emergency control measures according to law.

Article 9 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and administration of medical device adverse event monitoring and re-evaluation within their respective administrative regions, organize the investigation and handling of group adverse events of medical device that occurs within their respective administrative regions jointly with the health administrative departments at the same level and relevant authorities, and take emergency control measures according to law.

The drug regulatory departments at the level of the municipality consisting of districts or county level shall be responsible for medical device-related adverse event monitoring within their respective administrative regions.

Article 10 Drug regulatory departments shall guide and supervise subordinate drug regulatory departments in conducting supervision and administration on medical device adverse event monitoring and re-evaluation.

Article 11 Health administrative departments of the State Council and health administrative departments at all levels shall be responsible for supervision and administration of user facility of medical device related to medical device adverse event monitoring, urge user facility of medical device to carry out relevant medical device adverse event monitoring work and organize inspection, strengthen assessment of medical device adverse event monitoring, and take relevant control measures for medical device adverse events within their responsibility according to law.

Superior health administrative departments shall guide and supervise subordinate health administrative departments to carry out the supervision and administration related to medical device adverse event monitoring.

Article 12 National monitoring agencies shall be responsible for receiving medical device adverse events information reported by MAHs, distributing enterprises and user facility, assume relevant technical works related to medical device adverse event monitoring and re-evaluation nationwide; be responsible for the construction, maintenance and information management of national network and database of monitoring information of medical device adverse event, organize to develop technical specifications and guidelines, organize the investigation, evaluation and feedback of relevant adverse events information of the medical devices approved by the NMPA to be registered, summarize, analyze and guide relevant adverse events information of the medical devices approved by local drug regulatory departments above municipal level to be registered or filed, and investigate and evaluate group adverse events of medical device that have great influence nationwide and cause severe injuries or death and other serious consequences.

Article 13 The monitoring agencies designated by the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government (hereinafter referred to as provincial monitoring agencies) shall organize the technical works related to medical device adverse event monitoring and re-evaluation within their respective administrative regions; assume the investigation, evaluation and feedback of adverse events of the medical devices registered or filed within their respective administrative regions, and investigate and evaluate group adverse events of medical device that occurs within their respective administrative regions.

The monitoring agencies at the level of the municipality consisting of districts or county level shall assist in carrying out technical works related to medical device adverse event monitoring within their respective administrative regions.

Article 14 MAHs shall carry out continuous research on the medical devices already marketed, evaluate the risks, assume the responsibilities of medical device adverse event monitoring, take effective control measures based on the analysis and evaluation results, and fulfill the following main obligations:

(I) Establishing a medical device quality management system that incorporates medical device adverse event monitoring and re-evaluation working mechanism;

(II) Equipped with the organization and personnel corresponding to the products to carry out relevant works of medical device adverse event monitoring;

(III) Proactively collecting and truthfully and promptlyreporting medical device adverse events to monitoring agencies according to the time limit stipulated in the Provisions;

(IV) Promptly investigating, analyzing and evaluating medical device adverse events occurred, and promptlytaking measures to control risks and release risk information;

(V) Conducting continuous study on the safety of medical devices once they are on the market, and write periodic risk evaluation reports as required;

(VI) Actively carrying out medical device re-evaluation;

(VII) Cooperating with drug regulatory departments and monitoring agencies in investigation of medical device adverse events.

Article 15 In addition to fulfilling the obligations stipulated in Article 14 of the Provisions, overseas MAHs shall also establish information transfer mechanism with their designated agents to promptly exchange information related to medical device adverse event monitoring and re-evaluation.

Article 16 Medical device distributing enterprises and user facilities shall fulfill following major obligations:

(I) Establishing medical device adverse event monitoring working mechanism. Medical institutions shall also include medical device adverse event monitoring in medical institution quality management work priorities;

(II) Be equipped with the organization or personnel adapted to the scale of the business or use to carry out relevant works of medical device adverse event monitoring;

(III) Collecting medical device adverse events, promptly reporting to MAHs, and reporting to the monitoring agencies as required;

(IV) Cooperating with MAHs in the investigation and evaluation of medical device adverse events and medical device re-evaluation;

(V) Cooperating with drug regulatory departments and monitoring agencies in the investigation of medical device adverse events.

Chapter III Report and Evaluation

Section I Basic Requirements

Article 17 Medical device adverse events shall be reported based on the principle of "Report When in Doubt", that is, when an event is suspected to be a medical device adverse event, it shall be reported as a medical device adverse event.

The reporting content shall be authentic, complete and accurate.

Article 18 Any suspected medical device adverse events that have caused or possibly caused severe injuries or death shall be reported; for an innovative medical device, all the medical device adverse events shall be reported within initial registration period.

Article 19 MAHs, distributing enterprises and secondary medical institutions or above shall register as the users of the National Medical Device Adverse Events Monitoring Information System , voluntarily maintain the user information and report medical device adverse events. MAHs shall continuously track and handle monitoring information; in case of any change in product registration information, MAHs shall update the information in the system immediately.

Other user facilities are encouraged to register as the users of the National Medical Device Adverse Events Monitoring Information System and report the information related to adverse events.

Article 20 MAHs shall release the contact information such as telephone, correspondence address, email and fax, designate the contact person, and voluntarily collect the adverse event information from medical device distributing enterprises, user facility and users; In case of identifying or knowing any suspected medical device adverse event, MAHs shall report and evaluate the medical device adverse event directly through the National Medical Device Adverse Events Monitoring Information System and submit investigation report of group adverse events of medical device as well as periodic risk evaluation report.

In case of identifying o rknowing any suspected medical device adverse event, medical device distributing enterprises and user facility shall notify MAHs and report it through the National Medical Device Adverse Events Monitoring Information System. In case of having no conditions for online report temporarily, MAHs shall report to local monitoring agency above county level in paper form. The monitoring agency shall make online reporting on their behalf.

Monitoring agencies at all levels shall make their contact information open such as telephone and correspondence address.

Article 21 MAHs shall analyze and evaluate the medical device adverse event monitoring information collected and informed and actively carry out the study on medical device safety. For the medical device with conditional approval, MAHs shall carry out relevant works according to risk control plan.

Article 22 MAHs, medical device distributing enterprises as well as user facility shall establish and keep medical device adverse event monitoring records. The records shall be kept until 2 years upon shelf life expiration of medical devices; for those without shelf life label, the record-keeping period shall not be less than 5 years. The monitoring records of implantable medical devices shall be kept permanently, and medical institutions shall keep them in accordance with the relevant provisions for medical records.

Article 23 Provincial monitoring agencies shall carry out comprehensive analysis on adverse event reports of the medical devices registered or filed within local administrative regions, propose recommendations on supervisory measures for identified risks, and report to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government and national monitoring agencies within 30 days at each quarter end.

National monitoring agencies shall carry out comprehensive analysis on adverse event reports of the medical devices approved by the NMPA to be registered or filed and quarterly reports submitted by all the provinces, autonomous regions and municipalities directly under the central government, and if necessary, propose recommendations on supervisory measures to the NMPA.

Article 24 Provincial monitoring agencies shall yearly carry out Meta-analysis on the medical devices adverse event monitoring information registered or filed within local administrative regions, complete annual summary report, and submit it to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government and national monitoring agencies prior to March 15 each year.

National monitoring agencies shall carry out Meta-analysis on the annual monitoring information of medical device adverse events nationwide, complete annual report and submit it to the NMPA by the end of March each year.

The drug regulatory departments at provincial level or above shall notify the annual reports to the health administrative departments at the same level.

Section II Individual Medical Device Adverse Events

Article 25 In case of identifying or knowing any suspected medical device adverse event, MAHs shall immediately investigate the cause. Any event causing death shall be reported within 7 days ; and any event causing severe injuries or possibly causing severe injuries or death shall be reported within 20 days .

In case of identifying or knowing any suspected medical device adverse event, medical device distributing enterprises, user facility shall promptly notify MAHs. Any event causing death shall be reported within 7 days and any event causing severe injuries or possibly causing severe injuries or death shall be reported within 20 days through the National Medical Device Adverse Events Monitoring Information System.

Article 26 In case of identifying any medical device adverse event causing or possibly causing severe injuries or death, other units and individuals other than MAHs, distributing enterprises and user facilityshall report to either monitoring agencies or MAHs, distributing enterprises or the medical institutions providing treatment, and provide relevant medical records if necessary.

Article 27 The overseas MAHs of imported medical devices and the MAHs exporting domestic medical devices abroad shall voluntarily collect the adverse events of the products occurred abroad . For the adverse events causing or possibly causing severe injuries or death, the agents designated by overseas MAHs and the MAHs of domestically-produced medical devices shall report within 30 days upon the date of identification or notification.

Article 28 The monitoring agencies at the level of the municipality consisting of districts shall review the truthfulness, completeness and accuracy of the received medical device adverse event reports within 10 days upon the receipt date, and feed back to relevant MAHs promptly.

Article 29 After reporting medical device adverse events or knowing relevant medical device adverse events through the National Medical Device Adverse Events Monitoring Information System, MAHs shall carry out subsequent investigation, analysis and evaluation as required. The evaluation results of the events causing death shall be reported to local provincial monitoring agencies where MAHs locate within 30 days and the evaluation results of the events causing severe injuries or possibly causing severe injuries or death shall be reported to local provincial monitoring agencies where MAHs locate within 45 days . If the MAH has any new identification or notification of event information and evaluation results, it shall submit a supplementary reportas required.

Article 30 Local provincial monitoring agencies where MAHs locate shall complete the review of evaluation results within 10 days upon the receipt of evaluation results from MAHs, and if necessary, may carry out on-site investigation on the adverse events that cause or possibly cause severe injuries or death by entrusting or cooperating with the provincial monitoring agencies where adverse events occur. For the medical devices approved by the NMPA to be registered, national monitoring agencies shall also re-check the evaluation review results by provincial monitoring agencies, and if necessary, may organize investigation on the adverse events causing death.

Review and re-check results shall be fed back to MAHs. In case of any objection to the evaluation results of MAHs, MAHs may be required to carry out re-evaluation again.

Section III G roup Adverse Event of Medical Devices

Article 31 In case of identifying or knowing group adverse events of medical device, MAHs, distributing enterprises, user facility shall report to the drug regulatory departments and health administrative departments of the provinces, autonomous regions and municipalities directly under the central government where adverse events occur via telephone or fax within 12 hours, and may make a skip-level report when necessary. At the same time, they shall report basic information of group adverse events of medical device through the National Medical Device Adverse Events Monitoring Information System, and report each event as individual case report within 24 hours.

The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where adverse events occur shall promptly notify the relevant information to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where MAHs locate.

Article 32 In case of identifying or knowing group adverse events of medical device, MAHs shall immediately suspend the production and sales, and notify user facility to immediately stop using relevant medical devices. At the same time, MAHs shall carry out investigation and self-inspection of production quality management system and report to the drug regulatory departments and monitoring agencies of the provinces, autonomous regions and municipalities directly under the central government where MAHs locate and where the adverse events occur within 7 days .

Investigation shall include product quality profile, the correlation between the injury and the product, and compliance of the operation in the use and circulation process. Self-inspection shall include procurement, production management, quality control, and tracking of the same model and same batch of products.

MAHs shall analyze the cause of the event, release risk information in a timely manner, and report the self-inspection and control measures taken to the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where MAHs locate and where the adverse events occur, and shall recall relevant medical devices when necessary.

Article 33 In case of identifying or knowing group adverse events of medical device, medical device distributing enterprises and user facility shall notify MAHs within 12 hours , rapidly carry out self-inspection and cooperate with MAHs to carry out the investigation. Self-inspection shall include product storage, tracing of circulation process, and tracking of the products of the same model and same batch. Self-inspection of user facility shall also include whether the use process meets the operational specification and product instruction requirements. Medical device distributing enterprises and user facility shall suspend the sales and use of the medical devices when necessary and assist relevant units in taking relevant control measures.

Article 34 After knowing the group adverse events of medical device that occurs within their respective administrative regions, the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall promptly carry out on-site investigation jointly with the health administrative departments at the same level, and the drug regulatory departments of relevant provinces, autonomous regions and municipalities directly under the central government shall cooperate. Investigation, re-evaluation and handling results shall be promptly reported to the NMPA and the Health Administrative Department of the State Council, and copied to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central governmentwhere MAHs locate.

Article 35 For the group adverse event of medical devices causing serious consequences on a national scale and causing severe injuries or death and other serious consequences, the NMPA shall carry out relevant investigations jointly with the Health Administrative Department of the State Council. National monitoring agencies shall be responsible for on-site investigation while drug regulatory departments and health administrative departments of relevant provinces, autonomous regions and municipalities directly under the central government shall cooperate.

The investigation content shall include the occurrence of medical device adverse events, use of medical devices, diagnosis and treatment of patients, previous similar adverse events, production process of products, storage and circulation of products and tracking of the products of the same model and same batch.

Article 36 National monitoring agencies and relevant drug regulatory departments and health administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall, within 5 days upon the completion of an investigation, conduct technical evaluation on product risks according to the investigation and propose the recommendations on control measures, form investigation report and submit it to the NMPA and the Health Administrative Department of the State Council.

Article 37 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where MAHs locate may carry out on-site inspection on the MAHs associated with group adverse events. The NMPA may, when necessary, carry out on-site inspection on the overseas MAHs associated withgroup adverse events.

The on-site inspection shall include operation of production quality management system, product quality profile and production process as well as the tracking of products of the same model and same batch.

Section IV P eriodic Risk Evaluation Report

Article 38 MAHs shall conduct continuous research on the safety of medical devicesonce they are on the market, summarize and analyze the adverse event reports, monitoring data and domestic and overseas risk profile of products, evaluate its risks and benefits, record the risk control measures taken and completepost-market periodic risk evaluation report.

Article 39 MAHs shall, from the date of the first approval for registration or filing, complete the post-market periodic risk evaluation report in the previous year within 60 days after one full year . For those approved by the NMPA to be registered , the report shall be submitted to national monitoring agencies; for those approved to be registered at drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government, the report shall be submitted to local provincial monitoring agencies. Periodic risk evaluation report of Class I medical devices shall be kept by MAHs for future reference.

For the medical device with the approval for registration renewal, periodic risk evaluation report of this registration period shall be completed when the application for next registration renewal is submitted, and shall be kept by MAHs for future reference.

Article 40 The monitoring agencies above provincial level shall organize the review of the post-market periodic risk evaluation reports of medical devices received. They shall, when necessary, provide feedback of the review opinions to MAHs.

Article 41 Provincial monitoring agencies shall conduct comprehensive analysis on the post-market periodic risk evaluation reports received and submit the statistical information and analysis and evaluation results of the post-market periodic risk evaluation reports of the previous year to national monitoring agencies and local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government prior to May 1 each year.

National monitoring agencies shall conduct comprehensive analysis on the post-market periodic risk evaluation reports received and the statistical information and analysis and evaluation results submitted by provincial monitoring agencies, and submit the statistical information and analysis and evaluation results of the post-market periodic risk evaluation reports of the previous year to the NMPA prior to July 1 each year.

Chapter IV Intensive Surveillance

Article 42 The drug regulatory departments at provincial level or above may organize intensive surveillance on the medical device, and strengthen post-market risk study of medical devices.

Article 43 The NMPA shall determine the medical device varieties under intensive surveillance jointly with the Health Administrative Department of the State Council, organize to develop intensive surveillance project scheme and supervise the implementation.

National medical device varieties under intensive surveillance shall be determined according to the medical device registration, adverse event monitoring, supervisory inspection and testing and based on risk degree and product use.

National monitoring agencies shall organize the implementation of intensive surveillance project of medical devices and complete relevant technical report. The drug regulatory departments may take necessary management measures according to the risks identified in the monitoring.

Article 44 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government may, in accordance with the requirements for supervision and administration of medical device within their respective administrative regions, carry out provincial intensive surveillance project on Class II medical devices registered and Class I medical devices filed within their respective administrative regions by referring to Article 43 of the Provisions.

Article 45 MAHs of the medical device varieties under intensive surveillance shall, in accordance with requirements in intensive surveillance project of medical devices, carry out relevant works, voluntarily collect the adverse event reports of products and relevant risk information, write risk evaluation report and submit the report to authorities organizing the intensive surveillance project as required.

Article 46 The drug regulatory departments at provincial level or above may designate the units with certain qualifications to be monitoring sentinels to voluntarily collect intensive surveillance data. Monitoring sentinels shall provide the use information of medical device varieties under intensive surveillance, voluntarily collect and report adverse event monitoring information, organize or recommend relevant experts to carry out or to cooperate with monitoring agencies to carry out scientific research related to risk evaluation.

Article 47 MAHs of innovative medical devices shall strengthen voluntary monitoring of innovative medical devices, formulate product monitoring plans, voluntarily collect relevant adverse event reports and product complaint information, and carry out investigation, analysis and evaluation.

MAHs of innovative medical devices shall, within the first registration cycle, submit analysis, evaluation and summary report of product adverse event monitoring to national monitoring agency every half a year. In case of identifying any possible serious defects of a medical device, national monitoring agency shall promptly report to National Medical Products Administration.

Chapter V Risk Control

Article 48 In case of identifying the medical devices with improper risks that may endanger human health or life safety through medical device adverse event monitoring, MAHs shall take following risk control measures according to the situations and report to the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where they locate:

(I) Stopping producing and selling associated products;

(II) Informing medical device distributing enterprises and user facilityto suspend sales and use;

(III) Conducting product recall;

(IV) Releasing risk information;

(V) Carrying out self-inspection on production quality management system and make rectification for the relevant issues;

(VI) Revising the instructions, labels and operating manual, etc.;

(VII) Improving production process, design and product technical requirements etc.;

(VIII) Carrying out medical device re-evaluation;

(IX) Carrying out change registration or filing according to the regulations;

(X) Other risk control measures required.

MAHs shall promptly release the risks related to use safety of medical devices and disclose information to the public.

Article 49 Where drug regulatory departments believe that the control measures taken by MAHs are not sufficient to effectively prevent risks, they may take such measures as releasing warning information, suspending production, sales and use, ordering recall of relevant products, requiring revision of instructions and labels and organizing re-evaluation, and organize supervision and inspection on MAHs.

Article 50 For devices-related group adverse events, the drug regulatory departments at provincial level or above shall, based on risk profile, take the measures including suspending production, sales and use, and organize the supervision and inspection on MAHs, and release warning information and disposalinformation to the public promptly. After conclusion of technical evaluation, the drug regulatory departments at provincial level or above shall take further regulatory measures according to the relevant regulations and strengthen adverse event monitoring for medical devices of the same varieties.

The health administrative departments at the same level shall suspend the use of relevant medical devices in the medical institutions within their respective administrative regions and take measures to actively organize the treatment for patients. The relevant MAHs shall be cooperative.

Article 51 In case of identifying any unproper risk of medical devices during the evaluation and review of medical device adverse event reports, quarterly and annual summary report of adverse event reports, group adverse events evaluation, intensive surveillance and periodic risk evaluation reporting, the monitoring agencies above provincial level shall propose risk management opinions, provide timely feedback to MAHs and report to corresponding drug regulatory departments. Provincial monitoring agencies shall also report to national monitoring agencies.

The MAHs shall formulate and implement corresponding risk control measures taking into account risk management opinions received.

Article 52 The drug regulatory departments and health administrative departments at all levels may entrust medical device inspection agencies with corresponding qualification to inspect the products involved in medical device adverse events when necessary. A medical device testing institution shall perform the test promptly and issue the test report.

Article 53 Where imported medical devices are associated with medical device adverse events overseas , or domestically-produced medical devices are associated with medical device adverse events overseas with control measures taken, the designated agents of overseas MAHs or the MAHs of domestic medical devices shall, within 24 hours after being informed, report the information of overseas medical device adverse events, control measures and the control measures to be taken within the territory of China to the NMPA and national monitoring agencies, copy to the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government, and promptly report subsequentdisposal.

Article 54 Where suspected medical device adverse events are caused by inferior device quality, the drug regulatory departments shall take proper measures in accordance with relevant regulations of medical devices; where such events are caused by improper use of medical device, the health administrative departments shall take proper measures.

Chapter VI Re-Evaluation

Article 55 In case of any of following situations, MAHs shall voluntarily carry out re-evaluation and take corresponding measures based on re-evaluation conclusions:

(I) Cognitional changes of the safety and effectiveness of the medical device according to the development of scientific research;

(II) The monitoring and evaluation results of medical device adverse event indicate that the medical device may have defects;

(III) Other situations under which re-evaluation shall be performed as specified by the National Medical Products Administration.

Article 56 In case of carrying out medical device re-evaluation, MAHs shall, based on the product safety and effectiveness information learned after products are marketed, clinical data and use experiences, re-evaluate the summary information, study data, clinical evaluation materials, product risk analysis materials, product technical requirements, instructions, labels and other technical data and content in original registration materials of medical devices.

Article 57 Re-evaluation reports shall include product risk-benefit assessment, socio-economic benefit evaluation, technical progress evaluation and recommendations on measures to be taken.

Article 58 In case of voluntarily carrying out medical device re-evaluation, MAHs shall develop re-evaluation plan. Where control measures are required through re-evaluation, MAHs shall submit the re-evaluation report within 15 days upon the formation of re-evaluation conclusion. For medical devices approved by the NMPA to be registered or filed shall submit the report to national monitoring agencies; MAHs of other medical devices shall submit the report to the provincial monitoring agencies where MAHs locate.

Where MAHs fail to perform the obligation of re-evaluation on medical devices as stipulated, the drug regulatory departments at province level or above shall order such holders to carry out re-evaluation thereon. If necessary, the drug regulatory departments at the province level or above may directly organize re-evaluation.

Article 59 Where drug regulatory departments at provincial level or above order to carry out re-evaluation, MAHs shall submit the re-evaluation plan and re-evaluation report to the corresponding drug regulatory departments and monitoring agencies before implementation of re-evaluation and within 30 days upon the completion of re-evaluation.

Where the implementation period of re-evaluation plan exceeds 1 year, MAHs shall make annual report update each year.

Article 60 Monitoring agencies shall review the re-evaluation reports by MAHs and submit the review opinions to the corresponding drug regulatory departments.

Where the drug regulatory departments have objection to the re-evaluation conclusions by MAHs, which shall, in accordance with the requirements by drug regulatory departments, re-confirm the re-evaluation conclusions and carry out re-evaluation.

Article 61 Where drug regulatory departments organize to carry out medical device re-evaluation, the designated monitoring agencies shall formulate the re-evaluation plan, organize the implementation after the plan has been approved by the drug regulatory departments organizing re-evaluation, complete re-evaluation reports, and submit to corresponding drug regulatory departments.

Article 62 Where the re-evaluation results indicate that the registered or filed medical devices have defects that endanger personal safety, and cannot be eliminated or controlled risks through such measures as technical advances and revision of instructions and labels, or the risk/benefit ratio is unacceptable, MAHs shall voluntarily apply for the cancellation of medical device registration certificate or filing. In case MAHs do not apply for the cancellation of medical device registration certificate or filing, the original issuing authority shall cancel the medical device registration certificate or filing. The drug regulatory departments shall promptly release to the public the information related to the medical device registration certificate or filing cancelled.

The National Medical Products Administration may make the decision to eliminate the medical device variety based on the re-evaluation conclusion. The registration certificate or filing of eliminated products shall be cancelled by original issuing authority.

The medical device with the registration certificate or filing revoked shall not be manufactured or imported, distributed or used.

Chapter VII Supervision and Administration

Article 63 The drug regulatory departments shall, based on their responsibilities, supervise and inspect the medical device adverse event monitoring and re-evaluation carried out by MAHs and distributing enterprises, and supervise and inspect the medical device adverse event monitoring by user facility of medical device jointly with the health administrative departments at the same level.

Article 64 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall formulate supervision and inspection plan on medical device adverse event within the administrative region, and explicitly define inspection work focus and supervise the implementation.

Article 65 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall strengthen the training and assessment of staff engaging in medical device adverse event monitoring and re-evaluation within their respective administrative regions.

Article 66 The drug regulatory departments shall, in accordance with the requirements in the laws, regulations and specifications, supervise and inspect on the establishment and operation of adverse event monitoring system by MAHs. When necessary, the drug regulatory departments shall conduct extended inspection on enterprises entrusted by MAHs.

Article 67 In case of any of following situations, drug regulatory departments shall carry out the key inspection for MAHs.

(I) Failing to voluntarily collect and report medical device adverse events according to the time limits;

(II) If there is a big gap between the quantity of the adverse events that cause or possibly cause severe injuries or death reported by MAHs and those reported by medical institutions, it indicates the entity responsibilities of MAHs have not been fully implemented;

(III) Concealing, missing to report or submitting false report;

(IV) Failing to cooperate with the drug regulatory departments in relevant investigation of medical device adverse events and control measures to be taken;

(V) In case the safety and effectiveness of the product cannot be guaranteed due to failure to collect the safety-related information of product through adverse event monitoring as required, or failure to conduct post-market study and re-evaluation as required.

Article 68 Where MAHs fail to establish adverse event monitoring system and carry out adverse event monitoring and re-evaluation as required, fail to promptly take effective risk control measures in accordance with Article 48 of the Provisions, fail to cooperate with the drug regulatory departments in relevant investigation of medical device adverse events and control measures to be taken, the drug regulatory departments shall require them to stop production and make rectification, and take the control measure of stopping product sale when necessary.

Where the production or sale needs to be resumed, MAHs shall submit an application to the drug regulatory authority that makes the decision. After MAHs pass the on-site inspection by the drug regulatory departments, a decision of resuming production or sale shall be made.

Before submitting an application for resuming production or sale, MAHs may employ an independent third-party professional agency with corresponding qualification to conduct inspection for confirmation.

Article 69 The drug regulatory authority above provincial level should release in a unified manner the following medical device adverse event monitoring information:

(I) Information on group adverse event of medical device;

(II) Alerts on medical device adverse event monitoring;

(III) Medical device adverse event monitoring information requiring regularly release;

(IV) Other medical device adverse event monitoring information that needs to be released in a unified manner.

Chapter VIII Legal Liabilities

Article 70 In any of the following circumstances for MAHs, in accordance with Article 68 of the Regulations for the Supervision and Administration of Medical Devices, the drug regulatory departments above the county level should order to make correction and give warning, and a fine between 5,000 RMB and 20,000 RMB should be imposed if MAHs refused to make correction; in serious circumstances, the production should be instructed to stop until the relevant certificates are revoked by the original issuing authority:

(I) Failing to voluntarily collect and report medical device adverse events according to the time limits;

(II) Concealing, missing to report or submitting false report;

(III) Failing to submit evaluation outcome reports or submit investigation reports of group adverse events of medical device in accordance with the time limits;

(IV) Failing to cooperate with drug regulatory departments and monitoring agencies in relevant investigation of medical device adverse events and control measures to be taken.

Article 71 In any of the following circumstances for medical device distributing enterprises and user facility, in accordance with Article 68 of the Regulations for the Supervision and Administration of Medical Devices, the drug regulatory departments and the health administrative departments above the county level according to their respective responsibilities should order to make correction and give warning, and a fine between 5,000 RMB and 20,000 RMB should be imposed if MAHs refused to make correction; in serious circumstances, the production shall be ordered to stop until the relevant certificates are revoked by the original issuing authority:

(I) Failing to voluntarily collect and report medical device adverse events according to the time limits;

(II) Concealing, missing to report or submitting false report;

(III) Failing to cooperate with drug regulatory departments and monitoring agencies in relevant investigation of medical device adverse events and control measures to be taken.

Article 72 Where MAHs fail to carry out re-evaluation as required, conceal re-evaluation results, or fail to submit an application for cancellationas required, the drug regulatory departments at provincial level or above shall order them to make rectification and give a warning, and may impose a fine between 10,000 and 30,000 RMB.

Article 73 In any of the following circumstances for MAHs, the drug regulatory departments above county level should order to make correction and give warning, and a fine between 5,000 RMB and 20,000 RMB should be imposed if MAHs refused to make correction:

(I) Failing to establish medical device adverse event monitoring and re-evaluation mechanism according to related provisions;

(II) Failing to be equipped with the organization and personnel corresponding to the products to carry out the relevant medical device adverse event monitoring work as required;

(III) Failing to keep the records of adverse event monitoring or preserve the records for insufficient duration;

(IV) Failing to register as the user of the National Medical Device Adverse Events Monitoring Information System which shall be registered;

(V) Failing to voluntarily maintain user information, or fail to continuously track and dispose monitoring information;

(VI) Failing to take corresponding control measures according to the situation of adverse events and release to the public;

(VII) Failing to write, submit or keep post-market periodic risk evaluation reports as required;

(VIII) Failing to submit overseas medical device adverse events and overseas control measures as required;

(IX) Failing to submit analysis, evaluation and summary report of innovative medical device products as required;

(X) Failing to release contact information and voluntarily collect the information of adverse events;

(XI) Failing to carry out intensive surveillance on medical devices as required;

(XII) Other violations of the Provisions.

Article 74 In any of the following circumstances for medical device distributing enterprises and user facility, the drug regulatory departments and the health administrative departments above county level according to their respective responsibilities should order to make correction and give warning, and a fine between 5,000 RMB and 20,000 RMB should be imposed if MAHs refused to make correction.

(I) Failing to establish working system for medical device adverse event monitoring as required;

(II) Failing to be equipped with the organization and personnel corresponding to the scale of business or use to carry out relevant works of medical device adverse event monitoring as required;

(III) Failing to keep the records of adverse event monitoring or keep the records for insufficient duration;

(IV) Failing to register as the user of the National Medical Device Adverse Events Monitoring Information System as required;

(V) Failing to promptly report to MAHs the medical device adverse events collected or learned;

(VI) Failing to cooperate with MAHs in the investigation and evaluation of medical device adverse events;

(VII) Other violations of the Provisions.

In case of identifying any using unit having violations specified in preceding paragraph, the drug regulatory departments shall transfer the case to the health administrative departments at the same level for disposition.

Where the health administrative departments make decision of administrative penalty for user facilities, it shall promptly notify the drug regulatory departments at the same level.

Article 75 MAHs, distributing enterprises and user facility report, investigate, evaluate and dispose medical device adverse events in accordance with the requirements of the Provisions to proactively eliminate or reduceserious consequence, they shall impose a lighter or mitigated punishment for the relevant violations in accordance with Law of the People's Republic of China on Administrative Penalties, and impose no punishment for those having mild violations and making timely correction without causing serious consequences but are not exempt from other legal liabilities according to laws.

Article 76 Where the drug regulatory departments, health administrative departments and monitoring agencies at all levels and their staff fail to fulfill responsibilities in accordance with regulations, they shall be penalized in accordance with Article 72 and Article 74 of the Regulations for the Supervision and Administration of Medical Devices.

Article 77 Where MAHs, distributing enterprises and user facilities violate relevant regulations and thus causing damage to medical device users, they shall assume compensation liability according to law.

Chapter IX Supplementary Provisions

Article 78 The content of medical device adverse event report, risk analysis and evaluation report and statistical data are the basis for strengthening supervision and administration on medical devices and guiding proper use, but shall not serve as the basis for medical disputes, medical litigation or handling quality accident of medical devices.

Those falling under medical accident or medical device quality problems shall be handled separately in accordance with the requirements in the relevant regulations.

Article 79 The Provisions shall be interpreted by the NMPA together with the Health Administrative Department of the State Council.

Article 80 The Provisions shall be put into effect as of January 1, 2019 .

UDI of medical device in China marches rapidly

Wed, 06 Jan 2021 19:10:36 GMT

Resource: GS1 | The Global Language of Business

UDI of Medical Device (IVD) in China

As of June. 2022 , Unique Device Identifier (UDI) is obligatory for ALL class III medical devices . UDI is indispensable at s ubmission dossier, on all size of packagings, product itself (disposable and re-sterilised device exempted), at procurements as tender after approval, at incident reporting and medical reimbursement.

In Dec. 2022 a draft of 141 class II medical device was published which should be valid as of June. 2024.

In Mar. 2026 NMPA stipulates that

UDI of all class II medical device (IVD) and class I IVD must be implemented as of June. 2026
UDI of all class I medical device must be implemented as of June. 2029

Background

The UDI is composed of two parts: Device Identifier (DI) + Production Identifier (PI). The purpose of a UDI system can be summarized as follows:

a. traceability of medical devices, especially for field safety corrective actions,

b. adequate identification of medical devices through distribution and use,

c. identification of medical devices in adverse events,

d. reduction of medical errors,

e. documenting and longitudinal capture of data on medical devices

After IMDRF introduces UDI in a guidance in 2013 , many countries follow to regulate the traceability and vigilance code of medical device. The US acts as a pioneer as usual to let manufacturers register UDI from high risk products. As EU still struggles with European Databank on Medical Devices ( EUDAMED ) in which UDI as key parameters is included,

Art of UDI :

1-dimensional barcode
2-dimensional barcode
radio-frequency identification (RFID)

UDI issuing entities in China :

Implementing date of medical device of:

Class III: 06. 2022
Class II: 06. 2026
Class I: 06. 2029

* If product is manufactured earlier than the implementation date, UDI could be waived.

Database of UDI in China

Only Chinese agent (or Chinese subsidiary if applied) in behalf of foreign manufacturers can upload UDI at data base of NMPA.

T he UDI has a special character as key parameters at procurements and reimbursemen t in China. While the Chinese agent of foreign manufacturers is not aware to record UDI after e.g. first and second series of class III medical device, the other parties as local distributor might meet problem to fulfil UDI already at procurements and reimbursement process with provincial stakeholders earlier than implementing date of UDI by NMPA.

We recommend you to have a UDI procedure to handle the new requirements of UDI with central NMPA and with local distributor. The role of Chinese agent and Chinese distributor for foreign manufacturers must be defined and coordinated in good time manner.

Action in term of UDI in China

We recommend having procedure and records of UDI in your distribution of medical device in China, not only in legal manufacturer, but also at Chinese distributor.

Please take the following factors into account as of implementation date:

All medical devices in the 3 series of UDI-implementation should have records in all stakeholders in supply chain. So the medical device is traceable.
An internal database of registered medical device with UDI besides basic registration certification number, Chinese variant or version, product code, classification, intended use
UDI of smallest sale unit at product label on medical device
Submit UDI of smallest sale unit at label on medical device at product registration
Register all UDI-DIs (a t product and packaging), Classification and code of medical consumables for medical insurance in Chinese UDI-Database and “consumables classification and code database”

4. Last series of medical device (IVD) to mark and register UDI

Based on the NMPA Announcement No. 21 of 2026 regarding the subsequent batches of medical devices for Unique Device Identification (UDI) implementation:

The policy expands UDI requirements to all remaining medical devices following the initial implementation for Class III and select Class II products.
Starting June 1, 2027 , all Class II medical devices (including IVDs) and all Class I in-vitro diagnostic reagents manufactured must carry a UDI.
The final deadline is set for June 1, 2029 , by which time all Class I medical devices manufactured must be fully compliant with UDI coding and labeling.
Registrants and filers are required to upload UDI data to the national database and ensure consistency with medical insurance classification codes before products are sold.
Products manufactured prior to these respective deadlines are exempt from the UDI requirement and may continue to be sold without the unique identifier.

3. Third series of medical device to mark and register UDI (141 II medical device groups)

Implementing date and scope of UDI

As of 01, 06, 2024, class II medical devices below in third series which will be manufactured after this date must bear UDI.

As of 01, 06, 2024, UDI-DI on label of the smallest sales unit among these medical devices must be provided at initial -, change registration and renewal.

As of 01, 06, 2024, the info of UDI of these medical devices must be r egistered at central UDI database . It should be consistent with UDI at data base “National Medical Insurance Administration”. Manufacturers have to supplement medical insurance classification and code at UDI data base.

The change of UDI label doesn’t belong to significant change of products to initial change registration at NMPA. You have just to update the UDI-Database and consumables classification and code database in China.

List of medical device in third UDI-series

The following Chinese product codes are listed in draft guidance of third series of medical device UDI.

01 active surgical instruments

01 Ultrasonic surgery equipment and accessories

03 Ultrasonic surgery equipment accessories

02 Laser surgery equipment and accessories

02 Medical Laser Fiber

03 High frequency/radio frequency surgical equipment and accessories

01 High frequency surgical equipment

03 Argon protection gas condensation equipment

04 Electrodes and catheters for high frequency/radio frequency

05 Irrigation pump for radiofrequency ablation equipment

09 Endoscopic surgery with active equipment

01 Active equipment for endoscopic surgery

10 Other Surgical Equipment as Electric Stapler

04 Surgical power system

02 passive surgical instruments

01 Surgical Instruments - Knife

05 Knife for endoscop

03 Surgical instruments - scissors

03 Scissors for endoscopy

04 Surgical instruments - forceps

09 Endoscopic Tissue Forceps

10 Sampling forceps for endoscope

11 Separating forceps for endoscope

12 foreign body forceps for endoscope

13 Instrument forceps for endoscopy

07 Surgical instruments - needles

04 Endoscopic sampling needle

08 Surgical Instruments - Hooks

02 Hook for endoscope

09 Surgical Instruments - Curettes

02 Endoscopic Tissue Curette

10 Surgical instruments - stripper

02 Stripper for endoscope

11 Surgical Instruments - Retractors

04 Retractor for endoscope

05 Balloon dilator for endoscope

12 Surgical instruments- Piercing introducer

05 Introducer for endoscop

13 Surgical instruments - kiss (suture) instruments and materials

01 stapler (with nails)

02 stapler (without nails)

03 Kiss (suture) instruments for endoscopy (without nails)

04 Vascular suturing device

07 Non-absorbable sutures

15 Surgical instruments - other instruments

16 knot pusher for endoscope

17 Cell brushes for endoscopy

18 endoscopic stone extraction instruments

19 endoscopic incision retractor protector

20 endoscopic stone extraction balloon catheter

21 Balloon catheter for endoscopy

22 endoscope feeder

23 Endoscopic ligation device

03 Nerve and Cardiovascular Surgical Devices

10 Neurological and Cardiovascular Surgical Instruments - Retractors

03 dilator

11 Neurological and Cardiovascular Surgical Instruments - Puncture Introducers

01 hole punch

12 Neurological and Cardiovascular Surgical Instruments - Irrigators

01 Washer

02 cleaning rod

13 Neuro and Cardiovascular Surgical Devices - Cardiovascular Interventional Devices

04 Catheter Sterile Connector

12 puncture needles

14 introducer sheath

15 dilators

17 Balloon inflation device for balloon dilatation catheter

18 connection valve

25 extension tube

04 Orthopedic surgical instruments

01 Orthopedic knife

02 Orthopedic endoscopic knife

02 Orthopedic scissors

01 Scissors for Orthopedic Endoscopy

03 Orthopedic forceps

01 Orthopedic Endoscopic Forceps

05 Orthopedic Needles

02 traction needle

06 Orthopedic scraper

01 Orthopedic endoscope curette

07 Orthopedic Cone

01 Bone awl for interventional surgery

12 Orthopedic Active Devices

01 Orthopedic power surgery equipment

02 Supporting tools

13 External fixation and traction devices

02 External fixation bracket

14 basic general aids

01 Minimally Invasive Bone Guide

02 Bone cement instrument

03 Bone grafting device

16 Joint Surgical Auxiliary Instruments

01 bone cement setting mold

02 Arthroscopy supporting tools

17 Auxiliary instruments for spinal surgery

03 Injection propulsion device

04Vertebroplasty guidance system

05 Annulus suture instrument

06 Vertebral Posterior Edge Processor

13 Spinal Surgery Channel Instruments

15 supporting tools

18 Other Orthopedic Surgical Instruments

01 stripper

02 Skull Orthopedic Devices

06 Medical Imaging Devices

01 Diagnostic X-ray machine

02 Urinary X-ray machine

04 Dental X-ray machine

14 medical endoscope

01 Optical endoscope

03Electronic endoscope

16 Endoscopic Auxiliary Products

06 Biopsy bag for endoscope

07 Endoscopic bite, sleeve

07 Medical diagnosis and monitoring equipment

10 Accessories and consumables

03 body surface electrodes

04 Pulse oximeter sensor

05 Conductive Paste

08 Respiratory, anesthesia and first aid equipment

05 Auxiliary devices for breathing, anesthesia, and first aid equipment

06 Laryngoscope for endotracheal intubation

07 Atomization equipment / atomization device

06 Breathing, anesthesia tubes, masks

03 endotracheal intubation / endotracheal tube

04 Esophageal and tracheal intubation

05 laryngeal mask

06 Oropharyngeal/nasopharyngeal airway

07 bronchial occluder

08 nasal oxygen tube

09 suction catheter for airway (suction tube)

09 Physiotherapy equipment

03 Light therapy equipment

01 Laser therapy equipment

02 Photodynamic laser therapy equipment

04 Intense pulsed light therapy equipment

05 Red light therapy equipment

06 Blue light therapy equipment

10 Blood transfusion, dialysis and extracorporeal circulation equipment

03 Blood purification and peritoneal dialysis equipment

06 Peritoneal dialysis equipment

04 Blood purification and peritoneal dialysis equipment

04 Peritoneal dialysis equipment

12 Active Implantable Devices

01 Heart rhythm management equipment

10 Pacing system analysis equipment

11 Heart rhythm management program-controlled equipment

12 connector sleeve

02 Neuromodulation equipment

07 Test stimulator

08 Test extension lead

09 Neural regulation program-controlled equipment

03 Auxiliary hearing equipment

02 External sound processor

03 Auxiliary auditory control equipment

04 other

01 Implantable cardiac contractility

Adjustment equipment

14 Infusion, nursing and protective equipment

01 Injection and puncture equipment

01 Syringe pump

04 pen syringe

07 Syringe auxiliary push device

08 piercing instrument

09 biopsy needle

02 Intravascular infusion device

01 Infusion pump

12 Devices for transferring and dispensing medicinal liquid

05 Non-intravascular guide (insertion) tube

02 Nasoenteral nutrition catheter

03 catheter

04 rectal tube (anal tube)

05 Ureteral stent

06 drainage catheter

07 Dilation Catheter

08 contrast catheter

09 Manometry Catheter

06 Extracorporeal devices used in conjunction with non-intravascular catheters

01 Extracranial drainage collection device

02 Chest drainage device

05 negative pressure drainage sponge

06 Negative pressure drainage sealing film

12 Ostomy , scar care products

02 Scar Repair Materials

14 Protective equipment for medical staff

01 protective mask

02 protective clothing

16 Ophthalmic devices

03 Optical equipment and appliances

03 Vision therapy equipment

04 Ophthalmic measurement and diagnosis equipmentand utensils

01 Ophthalmic laser diagnostic equipment

05 Ophthalmic treatment and surgery equipment, assistive devices

04 Ophthalmic cryotherapy equipment

06 Ophthalmic Therapeutic and Surgical Aids

07 Ophthalmic implants and auxiliary devices

14 prosthetic eye tablets

15 Intraocular lens, artificial vitreous body implanted device

16 capsular tension ring implantation device

18 Obstetrics and gynecology, assisted reproduction and contraceptive devices

01 Obstetrics and Gynecology Surgical Instruments

05 Dilators and retractors for obstetrics and gynecology

10 Hysterosalpingography, fallopian tubes Fluid device

04 Obstetrics and gynecology treatment equipment

02 Gynecological prosthetic devices

07 Assisted reproductive devices

01 Assisted reproductive catheter

02 Assisted reproductive puncture egg retrieval/sperm needle

03 Assisted reproductive microtools

19 Medical rehabilitation equipment

01 Rehabilitation equipment for cognitive speech and audio-visual impairment

07 hearing aids

22 Clinical laboratory equipment

01 Hematology analysis equipment

02 Blood cell analysis instrument

11 Sampling equipment and utensils

04 Venous blood sampling tube

2. Second series of medical device to mark and register UDI

In the same year 2021 after publishing first series of class III medical device with UDI requirements, NMPA promulgates the second series of all rest class III medical devices which must be implemented with UDI requirements in Chinese market.

Implementing date of UDI for rest class III medical devices:

As of 01, 06, 2022, all class III medical device in second series which will be manufactured after this date must bear UDI.

As of 01, 06, 2022, UDI-DI on label of the smallest sales unit among these class III medical devices must be provided at initial -, change registration and renewal. As of 01, 06, 2022, the info of UDI of these class III medical devices must be registered at central UDI data base. It should be consistent with UDI at data base “ National Medical Insurance Administration ”.

1. First series of medical device to mark and register UDI (including 69 product codes)

Medical device with Product code below is in force to implement UDI as of 01, 01, 2021, it covers only 9 of 22 main product main categories in China:

Non-Stop Regulatory Affairs Service in China and globle

Medical Device Good Manufacturing Practice (GMP) in CHina

Medical Device Good Manufacturing Practice (GMP) (Order No. 107 of 2025)

Measures for the Administration of Drug Registration in China

Measures for the Administration of Drug Registration (2020)

Regulation of deficiency reply of technical documentation

Requirement for Supplementary Reply for Medical Device Registration Review

Principles for responding to notifications on supplementary reply for medical devices

Requirements for responding to notifications on supplementary reply for medical devices

Our analysis

Fast track of approved imported medical device

Production in China + approved imported medical device = Fast track at review and approval

Best practise

What can we support

Top 10 news in China in 2024

Top 10 news of medical device (IVD) in China in 2024

1. Medical device Act

2. Main stream of medtech in China

3. Medical Equipment Procurement Analysis Report

4. Revision of the Classification Catalogue of IVD

5. Chinese "Good distribution practise" takes effect

6. Overseas inspection by Chinese authority NMPA in trend

7. Sampling inspection

8. Usability validation

9. Chinese standards

10. Learn Chinese regulation by yourself

Trace Chinese Registration

Traceability Matrix at Chinese Registration

Why do you need traceability matrix for Chinese registration of medical device?

1. At whole development lifecycle

2. At registration dossier

3. At review stage by Chinese authority

4. At post market after Chinese approval

One important requirement matrix: product technical document for Chinese type testing

What can we support to manage Chinese PTR requirement?

Other Matrix should be traced for a successful project

Chinese standards in essential principle

Chinese standards listed in essential principle of Safety and Performance of medical device in 2022

Background

Meaning of Chinese standards

GB Standard

GB/T Standard

YY standard

YY/T standard

QM standards

Standards in essential principles at IMDRF

Service of essential principles of Safety and Performance, Chinese standards (English translation and gap analysis)

Example of guidlines

Examples of standards

Clinical study of Class III medical device in China?

Medical device groups needed for clinical study (accepted overseas data or in China)

Background

Which are new class III medical devices removed from old list of MD needed for clinical study in 2020?

What about requirements of other class III medical devices in term of clinical data?

Pathways of Chinese CER

Pathways of CER for 7 product groups explained by Chinese authority

Conclusion

E-Learning of Regulatory Affairs (Chinese registration and beyond)

Welcome to

E-learning of Chinese and global Compliance of medical device

Unique feature of E-learning

Testimonials

Learning audience

Leaning objective ﻿

Proof of E-learning

Example of one session in E-learning

Open Videos to share knowledge

1. Insight of essential webistes with regulation of medical device and IVD

2. In-country representative ( Chinese agent )

3. Chinese certificate of medical device and IVD

Payment

Standard MyCompliance

Professional Mycompliance

Overseas inspection of medical device and drug by Chinese authority

Chinese authority expands inspection of medical device, IVD and drug overseas

Understanding the applied regulation of overseas inspection

Common quality management items and process

Typical Chinese quality management items

Strategic skill to pass Chinese overseas inspection

Regulations for the Administration of Overseas Inspection of Pharmaceuticals & Medical Devices (No. 101 of 2018)

Medical Device Good Manufacturing Practice (GMP)
(Order No. 107 of 2025)

Leaning objective

L ife cycle of Chinese IFU