Regulatory news in China of medical device (IVD) in 2024



Trend of medical device in China

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

Be prepared with us. We can support your inpection as regulatory and quality expert in Europe.

See similar article, post approval activities in China

2.     We see that more and more manufacturer struggles to catch testing during the deficiency stage at registration of medical device by authority. Testing is time - and budget consuming. Verification and validation is a great part of development and registration.

We have development a tool with our Partner Matrix Requirement. You can trace testing requirement for typical type testing of medical device in China.

News of medical device in China

Overview

1. There is a summary report in term of Chinese registration of medical device and IVD by authority. Some interesting info are:

• Number of imported medical device
• Top 5 imported product groups

Quality management

1. Sampling inspection

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

See our summarised three annexes of this notification:

1.      National Medical Device Sampling Variety Inspection Plan

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

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

In first annex you can find applied product group, inspection items, standards and whether re-inspection is allowed.

If whether re-inspection is not allowed, the sampling should come from reserved medical device during serial (lot) production.

Among testing items, inspection items, standards are key parts of product technical requirements (PTR) for type testing.

Contact us if you want to

·        Full translation of three annexes and notification

·        have automatic control of inspection items and standards

·        have a mock audit manufacturing sites in and outside China

·        Inspect Chinese distributor

·        support preparation of potential sampling inspection

Registration

1.      Clinical evaluation and clinical trial

Can you believe that Chinese authority has a risk-based of clinical evidence of all product groups (22 main groups)?

After a full list of 3 types of clinical evidence (simplified clinical evaluation, complex clinical evaluation and clinical trial) in 2022, NMPA has revised the list of 25 group of medical device in 2024 (download).

#the complex clinical evaluation is very similar to European clinical evaluation (MDR), with more emphasis of equivalent comparison.

In this list in includes: 6 digit product code, device description, intended use, example and choice of 3 types of clinical evaluation.

How to use this collection?

For experienced manufacturer in China: you should check the updated clinical pathway in China and adjust next product generation upon the given clinical pathways.

For new manufacturer in China: you should have a gap analysis of clinical pathway. It can be tough to find equivalent data if second pathway (complex clinical evaluation) applies.

2. Usability validation

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

Here some highlights:

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

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

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

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

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

Contact us to have a gap analysis. For US manufacturer it is no trouble to his professional usability validation. It might be a new hurdle for manufacturers in other markets even in Europe to pass this validation.