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Top 10 news in Chinese medical device market in 2023

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 We are experts of Chinese registration of medical device for foreign manufacturer. In our articles we will reveal the regulatory highlights, special Chinese elements at registration, trend at Chinese market. Book our newsletter, follow us in linkedin and youtube. Use free consulting to start your Chinese success. Below we summarize the top new in 2023 in Chinese market of medical device and IVD.

01. Guidline

There are 64 general and product specific guidlines published in 2023 which might be a record among worldwide authorities.

Here are some examples:

  • Guidelines for Registration and Review of Clinical Evaluation of Artificial Intelligence-Assisted Detection Medical Devices (Software) (No. 38, 2023)

  • Guidlines for Registration and Review of Clinical Evaluation of Similar Types of Medical X-ray Diagnostic Equipment (Category III) (No. 30, 2023)

  • Benefits of Medical Device Products - Technical Guidelines for Risk Determination (2023 Revised Edition) (2023 No. 25)

  • Guidelines for Registration Review of Disposable Infusion Equipment Products (2023 Revised Edition) (2023 No. 15)

  • Registration Review Guidelines for Drug-Coated Balloon Dilatation Catheters (No. 9, 2023)

 

What is product specific guidlines? It is similar to FDAs guidlines stipulating requirements of respective product groups for development and registration. It is similar to MDRs common specification which is only in theory so far in EU.

 

The new issued guidlines incorporate essential requirements of submission dossier. Oft specified are details of performance parameters, risk management, type testing, product technical requirement, clinical evaluation, clinical study, labelling, verification and validation. It is wise to fulfil these requirements to avoid deficiency at product registration.

02. Product code – Guidline – Standards

Database of Chinese Product code – Guidline – Standards

Chinese authority has updated layout of “requirement dictionary” again which matches product code with guidance and standards. In the illustration below is an example of “Computer-aided diagnostic/analytical software”. To underscore is also the info of clinical pathway, intended use and classification.

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03. Registration statistic

 

Do you know that Chinese authority publishes every month the review statistic?

In the recent Oct, 2023, CMDE receives 1641 applications (initial, change and renewal) of class II and III medical device and IVD. Among them only 1305 cases are passed though acceptance review.

 

There are 448 change fillings class I medical device (94 are foreign products). After acceptance review, 450 technical deficiency letters were issued.

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There are 304 quality management inspections with 254 results in the whole year.

56 applications of innovative products were received and only 4 are approved.

04. Summary report of technical review of approved medical device

97 technical summaries of approved medical device are published (similar to 510k summary at FDA). It is useful for manufacturer with similar medical device to follow the registration strategy.

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We translated one example of Coronary CT Fractional Flow Reserve Calculation Software. In the summary it is quite briefly documented with contents as working principle, specification study, software study, clinical trial and risk benefit analysis. Unique information from reviewer is a note that manufacturer has to provide follow up data (equivalent to Post-Market Clinical Follow-up) in next renewal after 5 years.

 

Contact us to get the translation.

05. GB 9706 series standards arriving transition deadline 

The authority was clever to permit 3 years transition period for most GB 9706 series standards (equivalent to IEC 60601s). 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).

 

NMPA expanded new transition of GB 9706 series to another 3 years (2 years for class I). If more GB 9706 series apply to one product, the latest deadline of the standard is deciding. If only GB 9706.1-2020 (originally valid on May, 2023) applies to one active product, change registration must be completed prior to May, 2026. The deadline means completeness of registration, NOT the testing per se.

 

The obligatory Chinese GB-standards trigger change registration. We suggest the legal manufacturers to start to test their medical devices conform to new 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 apply to your products contact us to have a gap analysis of Chinese standards.

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06. UDI

After UDI all class III medical device must be uploaded in UDI-database and implemented in Chinese supply chain on all selling packages. The third series of parts of class II are listed, 103 product groups only. The deadline is July, 2024. The deadline refers to manufacturing date of medical device which means these 103 class medical device produced prior to July, 2023 can be placed in China without UDI.

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See our summarised UDI overview with details of third batch of class II MD.

07. 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/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 professional regulations and on the other site meaningful due to so many valuable information collected through medical software by huge Chinese population.

08. Local to transfer (production in China)

Since “made in China” products are preferred at Chinese tender. More and more foreign manufacturers moved production of approved medical device and even new products benefiting from “made in China”.

In 2023 we found 2 examples of accelerated registration of approved foreign products with production in China.

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  1. The famous one is model IS4000CN as surgical system by da vinci and Chinese joint venture intufosun. This product is used for urological surgeries, general surgical laparoscopic surgeries, obstetrics and gynecology laparoscopic surgeries, thoracic surgery laparoscopic surgeries, laparoscopic-assisted cardiotomy surgeries, and can be combined with mediastinal incisions for coronary vascular reconstruction arterial anastomosis.

  2. ​

  3. The subsidiary of Philips in province Guangdong made another transfer to local example, class II medical software M3290B. It is used for physiological waveform parameters (including ECG, pulse, respiration, pulse oximetry, non-invasive hemoglobin, non-invasive blood pressure, intravascular oxygen saturation, invasive blood pressure, body temperature, carbon dioxide, cardiac output/continuous cardiac output, blood Collection, trend display, alarm and report generation of mild injection temperature, lung function, EEG, EEG bispectral index, gas, transcutaneous gas and muscle relaxation).For accelerated approval it needs only 5 days.

 

Our analysis: the approval of “transfer to local” product could be smooth. However the preparation often at local testing and other gap documents takes time. The transfer of product design to Chinese manufacturing over 2 complex international quality systems is more than challenging.

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09. Report of sampling inspection

Each year Chinese authority provides a list of medical device with given standards which are among monitoring of inspection by authority. In this case, the device will be tested compliant to approved specifications in a certified Chinese lab.

 

In a report in Dec, 11 product types and 16 manufacturers are named due to non-compliance. Among 16 manufacturers there are 3 foreign manufacturers:

  • GALLINIS.R.L.

  • Nidek Medical Products,Inc

  • Abbott Diagnostics Medical Co., Ltd.

10. Chinese GSP

NMPA has revised guidance (valid as of July, 2024) of “good supply practise” (GSP) since first publication in 2014. It applies to all Chinese distributors. The details of new guidance are characterised with ISO 13485 elements. Although Chinese authority doesn’t certify Chinese distributors, it is supposed to be strengthened based on new regulation.

We name some important articles:

  • Article 12: distributor should submit an annual quality report as similar report by manufacturers

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

  • Article 17: person in charge of the enterprise should get at least once one year quality report by person in charge of quality.

*=management review

  • Article 19: reinforce the role of quality manager at distributor

  • Article 20: list 24 quality measurements

*it means process and record which might be in focus inspected

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