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, the 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 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. 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.