Deficiency Reply at Chinese registration

When to reply of deficiency at Chinese authority

There are official 2 time points of deficiency at which still *N times of deficiency rounds  under defiend questions could happen. There is also a possible pre-sub, unofficial review when also questions can be raised. Summarized are official deficiency letters at

·        5 days after submission of dossier at acceptance review

·        60 days for class II MD and 90 days for class III MD at technical review

*N times doesn’t mean to raise new topics of questions but the question under same category as physical testing or software file as initial asked.

Template of deficiency reply

1. Not applicable

“Our device is not an active device which has no software. So this chapter CH x and under belonging subchapters are not applicable.”

 

Non-Go: cross reference of another chapter. Instead just repeat or summarize the essential contents.

2. Related to change

It is a usual question that no new assessment or report or risk management is analyzed for respective changes. It is rational to give a table of content if the replies are more than 2 documents.

 

The change of critical component N from supplier A to B has no impact of specification of component and whole device. The mechanical test report is still valid to use in CH X.Y. Z, s page X of summary. At responding test evaluation (s. page Y discussion of change) we consider the new critical component in assembling and electrical process. It has no impact on safety and effectiveness of medical device.

Besides please reference the safety data and supplier notification of new critical component.

 

3. Summary of complex questions

The software change has minimal impact of software file compliant to guidance of medical software in China. Compared to former released SW-version we updated

CH X.Y.Z Software file summary with comparison table of subject and former SW-version

CH X.Y.Z Verification and Validation test

CH X.Y.Z Cybersecurity

CH X.Y.Z IFU

 

Example of deficiency reply to Chinese authority

Classification code: 07-03-03

Product category: Non-invasive blood pressure measurement equipment

Product example: Electronic blood pressure monitor Management

Classification: II

Technical review and supplement

FAQ: Product technical requirements: 1. It should include the labeling requirements of clause 4.2 in YY0670-2008 "Non-invasive automatic blood pressure monitor", including the relevant requirements of equipment labeling, outer packaging, instructions, component labeling (component replacement, power system labeling, battery-powered equipment labeling, cuff labeling).

2. If it is an automatic cycle non-invasive blood pressure monitoring device, it should comply with the provisions of YY0667-2008 "Medical Electrical Equipment Part 2: Special Requirements for Safety and Basic Performance of Automatic Cycling Non-invasive Blood Pressure Monitoring Equipment".

3. According to the "Guidelines for Registration Review of Medical Device Software (Revised in 2022)", the following requirements should be included: software functions, usage restrictions, interfaces, access control, operating environment (if applicable), performance efficiency (if applicable), etc. Among them, the functions clearly define the outline of all core functions (including security functions) of the software, indicating optional and automatic functions; the objective physical measurement function clearly defines the measurement accuracy indicators; the data resources (such as reference databases) clearly define the data types and sample sizes of each type of data; if the core functions are the same but the core algorithm types are different, each type of core algorithm needs to be noted; usage restrictions include user usage restrictions and technical restrictions; interfaces include application program interfaces for users to call, data interfaces (including transmission protocols, storage formats, such as wifi, Bluetooth, GPRS, USB, DICOM, HL7, JPG, PNG, etc.), and product interfaces (other medical device independent software and medical device hardware products that can be used in conjunction); access control clearly defines the user identity authentication method, user type and user access rights of the software; operating environment and performance efficiency are applicable to externally controlled software components, and dedicated independent software is regarded as software components, among which the operating environment (including cloud computing) clearly defines the typical configuration, including hardware configuration, external software environment, and network conditions; performance efficiency clearly defines the time characteristics of the software to complete typical core functions under a typical operating environment, and if applicable, clearly defines resource utilization and capacity.

4. If the pulse rate measurement function is included, the measurement range and error of the pulse rate should be specified.

5. The software functions declared in the manual should be clearly stated and reflected in the technical requirements. Common software functions of electronic sphygmomanometers include: low voltage prompt function, memory function (including memory group number), blood pressure warning function, voice broadcast function, time and date setting, systolic and diastolic blood pressure display, "KPa and mmHg" unit display, etc.

6. According to the requirements of 4.5.5 of YY0670-2008 "Non-invasive Automatic Measurement Sphygmomanometer", provide a verification report on the overall effectiveness of the system.

 

Classification code: 06-03-03

Product category: X-ray tube assembly

Product example: X-ray tube assembly, medical diagnostic X-ray tube assembly Management

Classification: IITechnical review and supplement

FAQ: Product technical requirements: 1. It should comply with the relevant requirements of YY/T0609-2018 "General Technical Conditions for Medical Diagnostic X-ray Tube Assemblies" (including 5.16). It should be noted that the performance indicators should formulate relevant requirements for the instructions, such as the main dimensions of the X-ray tube assembly should be clearly stated in the instruction manual (the unmarked tolerances of the dimensions comply with the V-level provisions in GB/T1804-2000 "General Tolerances - Tolerances of Linear and Angular Dimensions without Tolerances"), the wiring diagram of the X-ray tube assembly, the nominal X-ray tube voltage, the nominal photographic anode input power, the nominal CT anode input power, the nominal continuous input power, the filtration of the X-ray tube assembly, and the expected service life; for the CT tube assembly, the basis for determining the expected service life should also be given in the instruction manual.

2. It should comply with GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance", GB 9706.103-2020 "Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance Parallel Standard: Radiation Protection of Diagnostic X-ray Equipment" and GB9706.228-2020 "Medical Electrical Equipment Part 2-28: Special Requirements for Basic Safety and Essential Performance of Medical Diagnostic X-ray Tube Assemblies".

 

Classification code: 06-13-04

Product category: Surgical microscope (non-ophthalmology)

Product example: surgical microscope, surgical microscope image acquisition and processing system management

Classification: II

Technical review and supplement FAQ: Product technical requirements: 1. According to the "Guidelines for Registration and Review of Medical Device Software (2022 Revised Edition)", the following requirements should be included: software functions, usage restrictions, interfaces, access control, operating environment (if applicable), performance efficiency (if applicable) and other requirements. Among them, the functions clearly define the outline of all core functions (including security functions) of the software, and indicate the optional and automatic functions. Among them, the objective physical measurement function clearly defines the measurement accuracy indicators, and the data resources (such as reference databases) clearly define the data types and sample sizes of each type of data. If the core functions are the same but the core algorithm types are different, each type of core algorithm needs to be noted; usage restrictions include user usage restrictions and technical restrictions; interfaces include application program interfaces for users to call, data interfaces (including transmission protocols, storage formats, such as wifi, Bluetooth, GPRS, USB, DICOM, HL7, JPG, PNG, etc.), and product interfaces (other medical device independent software and medical device hardware products that can be used in conjunction); access control clearly defines the user identity authentication method, user type and user access rights of the software; operating environment and performance efficiency are applicable to externally controlled software components, and dedicated independent software is regarded as software components. Among them, the operating environment (including cloud computing) clearly defines the typical configuration, including hardware configuration, external software environment, and network conditions. Performance efficiency clearly defines the time characteristics of the software to complete typical core functions under a typical operating environment, and if applicable, clearly defines resource utilization and capacity.

2. It should comply with the requirements of GB 11239.1-2005 "Operating Microscope Part 1: Requirements and Test Methods".

3. Equipment equipped with foot switches should comply with the requirements of YY 1057-2016 "General Technical Conditions for Medical Foot Switches".

4. If equipped with an image acquisition and processing system, assistant mirror or other accessories, relevant requirements should be specified according to the product's own functional characteristics, such as central resolution, magnification, irradiance, image resolution, frame rate, image quality, field of view, excitation light wavelength (if applicable), receiving light wavelength (if applicable), etc.

5. It is recommended to provide optical radiation safety verification information, and it is recommended to use GB/T 20145-2006 "Photobiological Safety of Lamps and Lamp Systems". GB/T 20145-2006 is applicable to all incoherent broadband electric light sources, including LED light sources.

6. If the product contains lasers, it should comply with GB 7247.1-2012 "Safety of Laser Products Part 1: Equipment Classification and Requirements".

 

Classification code: 06-07-02

Product category: Ultrasonic echo Doppler imaging equipment

Product example: Color ultrasound diagnostic system, color ultrasound diagnostic instrument, color Doppler ultrasound diagnostic system, full-digital color ultrasound diagnostic instrument, color Doppler ultrasound diagnostic instrument, portable color ultrasound diagnostic instrument, portable color Doppler ultrasound diagnostic system, full-digital color ultrasound diagnostic system Management

Classification: II

 

Technical review and supplement FAQ: Product technical requirements: 1. If it has a Doppler probe for intracranial blood vessels, it shall comply with the relevant requirements of YY 0593-2015 "Ultrasonic Transcranial Doppler Blood Flow Analyzer".

2. For equipment with ECG signal detection units, refer to the relevant requirements of YY 1079-2008 "Electrocardiogram Monitor".

3. Equipment equipped with a foot switch shall comply with YY1057-2016 "General Technical Requirements for Medical Foot Switches".

4. According to the requirements of GB/T 14710-2009 "Environmental Requirements and Test Methods for Medical Electrical Appliances" and YY/T 1420-2016 "Environmental Requirements and Test Methods for Medical Ultrasonic Equipment", the inspection items and inspection conditions of environmental testing shall be specified.

5. It shall comply with GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance" and GB 9706.237-2020 "Medical Electrical Equipment Part 2-37: Special Requirements for Basic Safety and Basic Performance of Ultrasonic Diagnostic and Monitoring Equipment".

6. According to the "Guidelines for Registration and Review of Medical Device Software (2022 Revised Edition)", the following requirements shall be included: software functions, usage restrictions, interfaces, access control, operating environment (if applicable), performance efficiency (if applicable), etc. Among them, the functions clearly define the outline of all core functions (including security functions) of the software, and indicate the optional and automatic functions. Among them, the objective physical measurement function clearly defines the measurement accuracy indicators, and the data resources (such as reference databases) clearly define the data types and sample sizes of each type of data. If the core functions are the same but the core algorithm types are different, each type of core algorithm needs to be noted; usage restrictions include user usage restrictions and technical restrictions; interfaces include application program interfaces for users to call, data interfaces (including transmission protocols, storage formats, such as wifi, Bluetooth, GPRS, USB, DICOM, HL7, JPG, PNG, etc.), and product interfaces (other medical device independent software and medical device hardware products that can be used in conjunction); access control clearly defines the user identity authentication method, user type and user access rights of the software; operating environment and performance efficiency are applicable to externally controlled software components, and dedicated independent software is regarded as software components. Among them, the operating environment (including cloud computing) clearly defines the typical configuration, including hardware configuration, external software environment, and network conditions. Performance efficiency clearly defines the time characteristics of the software to complete typical core functions under a typical operating environment, and if applicable, clearly defines resource utilization and capacity.

7. The software functions declared in the manual should be clarified and reflected in the technical requirements. Common software functions: various display modes, image adjustment, image playback, image storage and reporting, measurement calculation, specific measurement items of each measurement module, etc.

Clinical evaluation data: 1. If the product only includes basic ultrasound B-mode imaging, basic pulse wave Doppler (PW) and continuous wave Doppler modes (CW), and basic ultrasound color blood flow imaging modes, and does not include imaging modes/functions (such as composite imaging, harmonic imaging, ultrasound blood flow vector imaging) or unconventional application methods generated by modifying beamforming, image pre-processing, and image post-processing algorithms on this basis, it can be exempted from clinical evaluation.

2. If clinical evaluation is required, clinical evaluation data should be provided in accordance with the National Medical Products Administration's notice on the release of five technical guidelines including the technical guidelines for clinical evaluation of medical devices and the "Technical Review Guidelines for Clinical Evaluation of the Same Type of Imaging Ultrasound Diagnostic Equipment".

 

Classification code: 06-14-03

Product category: Electronic endoscope

Product example: Electronic cystoscope, electronic cystopelvic endoscope Management

Classification: II

 

Technical review and supplement FAQ: Product technical requirements: 1. Optical performance: There should be requirements for the center resolution and depth of field of the field of view; if it is a hard endoscope, the viewing angle requirements should be formulated in accordance with YY0068.1-2008 "Medical Endoscope Rigid Endoscope Part 1: Optical Performance and Test Methods".

2. Mechanical properties: Dimensional parameters include working length, head end outer diameter, working channel inner diameter, insertion part outer diameter, etc.; there should be requirements for control performance, suction performance (if applicable), bending performance (if applicable), sealing performance (reusable products should pay attention to), performance with accessories (if applicable), etc.; the mechanical properties of rigid electronic endoscopes should comply with the requirements of YY/T0068.2-2008 "Medical Endoscope Rigid Endoscope Part 2: Mechanical Properties and Test Methods".

3. The materials used in the patient contact part shall comply with the requirements of clause 4.1 of YY/T1587-2018 "Medical Endoscope Electronic Endoscope", including 4.1.1 Metal surface materials and 4.1.2 Chemical composition requirements.

4. If the product is sterile and disposable, there should be sterility-related requirements. For example, if ethylene oxide is used for sterilization, there should be requirements for ethylene oxide residues; the sterility inspection of the product shall be carried out in accordance with the Chinese Pharmacopoeia (2020 edition).

5. If built-in LED lighting is used, the requirements for the radiant flux ratio of red, green and blue light, infrared cutoff performance, total output luminous flux, and safety measures for fault prevention specified in YY/T 1081-2011 "Medical Endoscope Endoscope Function Supply Device Cold Light Source" and "Guidelines for Technical Review of Registration of Cold Light Sources for Medical Endoscopes" shall be referred to.

6. If the product contains other accessories besides the mirror body, such as forceps pipeline opening valve/liquid stop valve, etc., the technical requirements should clearly specify the relevant requirements for accessory size, function, etc.

7. It should comply with GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance", YY 9706.102-2021 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Parallel Standard: Electromagnetic Compatibility Requirements and Tests", GB 9706.218-2021 "Medical Electrical Equipment Part 2-18: Special Requirements for Basic Safety and Essential Performance of Endoscopic Equipment".

8. If it contains software components, according to the "Guidelines for Registration and Review of Medical Device Software (2022 Revised Edition)", it should include the following requirements: software functions, usage restrictions, interfaces, access control, operating environment (if applicable), performance efficiency (if applicable) and other requirements. Among them, the functions clearly define the outline of all core functions (including security functions) of the software, and indicate the optional and automatic functions. Among them, the objective physical measurement function clearly defines the measurement accuracy indicators, and the data resources (such as reference databases) clearly define the data types and sample sizes of each type of data. If the core functions are the same but the core algorithm types are different, each type of core algorithm needs to be noted; usage restrictions include user usage restrictions and technical restrictions; interfaces include application program interfaces for users to call, data interfaces (including transmission protocols, storage formats, such as wifi, Bluetooth, GPRS, USB, DICOM, HL7, JPG, PNG, etc.), and product interfaces (other medical device independent software and medical device hardware products that can be used in conjunction); access control clearly defines the user identity authentication method, user type and user access rights of the software; operating environment and performance efficiency are applicable to externally controlled software components, and dedicated independent software is regarded as software components. Among them, the operating environment (including cloud computing) clearly defines the typical configuration, including hardware configuration, external software environment, and network conditions. Performance efficiency clearly defines the time characteristics of the software to complete typical core functions under a typical operating environment, and if applicable, clearly defines resource utilization and capacity.

Inspection report: 1. Typical products for registration inspection should be products within the same registration unit that can represent the safety and effectiveness of other products within the unit. The same registration unit selects the model with the most complex structure, the most functions, and the highest technical indicators for inspection. Usually, endoscopes of different specifications and models within the same registration unit only differ in length, diameter, and inner diameter of the working channel. The one with the smallest diameter and the largest slenderness ratio (length/diameter) should be selected for inspection. If it contains a working channel, the diameter is the outer diameter of the insertion part minus the inner diameter of the working channel; if it does not contain a working channel, the diameter is the outer diameter of the insertion part; if there are differences in viewing angles, the maximum value should be selected; if there are differences in field of view angles, the maximum and minimum values ​​should be selected; the optical performance indicators such as the resolution of the center of the field of view should select the model with the highest requirements. If the inspection of one model cannot cover other models