Medical Device Good Manufacturing Practice (GMP) in CHina
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.
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