Consolidated newsletter of regulation of medical device and IVD in China (2024)

The manufacturers are used to analyse new regulations. There are so many different newsletters sooner or later. We realize that fewer manufacturers categorise the regulation and look after them intelligently.

These below are summarised Chinese regulations of medical device and IVD in 2024.

Contact us for the whole regulations with details and links. You can have a customer tailored booking of our non-stop news radar.

1.    Regulation (or notification) of medical device (IVD) in China

1.1 Chinese authority NMPA made a draft of medical device act which will act as law for medical device (IVD) in China. It replaces “Regulations on the Supervision and Administration of Medical Devices”.

The medical device act is more MDR-like in EU with its formulation, length and emphasis but for sure with Chinese elements.

We have following analysis. The speculation will take some years till final publication of medical device act.

11 chapters and 190 articles:

Chapter 1 General Provisions

Chapter 2 Medical Device Standards and Classification

Chapter 3 Medical Device Development

Chapter 4 Medical Device Production

Chapter 5 Medical Device Operation

Chapter 6 Import and Export of Medical Devices

Chapter 7 Use of Medical Devices

Chapter 8 Medical Device Alerts and Recalls

Chapter 9 Supervision and Management

Chapter 10 Legal Liability

Chapter 11 Supplementary Provision

Speculations: 

-The law takes some years till final version

-new chapters: chapter 3 R&D, chapter 6 import and export, chapter 7 usage

-Strength of responsibility of legal representative (=chinese agent)

-Legal representative will be stricter qualified by having manufacturing or distribution licence

-Switch of medical device registration certificate possible

-Accelerate of review of clinical study and preference of multi-centre clinical trial

Read original notification

1.2 There are updates of classification for medical device und IVD.

NMPA adjusts annually the classification of medical device. The trend is downclassification of most devices.

Read new determination of classification and how to apply for classification

1.3 Do you have Chinese distributor?

This guidance might be new for all manufacturers. Chinese authority has a guidance of good distribution practise.

The scope of guidance is similar to ISO 13485 in terms of procedure and records.

Read

1.4 Revision of the Classification Catalogue of IVD 

There is Revision of the Classification Catalogue of IVD in China which is valid in 2025. Unlike 3 levels of product code of medical device, IVD has 2 levels, under 1th level 25 main groups, together with 2th level 1852 product code of IVD.

Besides it, we summaries:

• For IVD certificates approved and effective before January 1, 2025, they shall remain valid during the approved validity period.

• Starting from January 1, 2025, for IVD that have applied for registration for the first time, product registration applications shall be accepted in accordance with the Classification Catalogue. 

• For extension registration applications that have been accepted before January 1, 2025, but have not yet been approved, continue to review and approve them in accordance with the original "Classification Catalogue" .

2.    Guidances to develop and approve medical device

2.1 There is even a consolidated collection matching guidance, standard and product code in Chinese database, see the link.

General

Usability guidance published on 2024-03-19

One expert at authority compares usability requirements of medical device in China and US. Read

Product-specific

18 guidances published on 2024-01-03

4 guidances published on 2024-02-06

4 guidances published on 2024-03-18

48 guidances published on 2024-05-27

20 guidances published on 2024-06-17

12 guidances published on 2024-08-12

6 guidances published on 2024-09-29

2.2 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.

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

3.    Standard for Medical Device Compliance

3.1  CMDE issues obligatory standard for medical device in the next years. Pay attention of validity of standards. Before this date, a change registration must be completed.

3.2  CMDE issues 20 medical device standards on 2024-02-28

3.3  CMDE issues 2 medical device standards on 2024-07-08

3.4  CMDE issues 36 medical device standards on 2024-07-10

4.    Quality management system and post market

4.1  At the same there is a kind of sampling inspection locally. Each year authority list the focus of types of medical device and inspection items, see  it in 2024.

So far there are 5 notices  of findings of local and foreign medical devices.

Dec , Oct , Sep ,  Jul , Jul 

4.2  Another inspection is overseas inspection on site or remote at foreign manufacturers

Read another examples of non-conformity of manufacturers from Italy and Korea. The medical device of both manufacturers are blocked to China.

We accompanied many inspections especially for manufacturer with his distributor as Chinese agent  lacking regulatory and quality knowledge.

The focus is absolutely at production of approved medical device. The suggestion is to study given plan master file and checklist carefully. It will be asked items by items instead of providing an audit agenda.

5.    News for Medical Devices

5.1  As of June this year, China has launched 92 AI medical imaging software with automatic detection functions that are managed as Class III medical devices, covering cardiovascular (27), pulmonary (24), cerebrovascular (13), orthopedic (10), fundus (9), breast (2) and other disease areas.

Read

5.2 A nice summary about booming businiss of Recombinant collagen in China.

Read

5.3 In some pilot areas in China it is allowed to establish foreign hospitals.

Read

5.4 Medical Equipment Procurement Analysis Report 

There is an analysis report of procurement about country hospital (smaller than city). The power of procurement in Q1 in 2024 is decreased by almost 50%. However these types of product have a better quote than procurement of average products: 

Radiotherapy equipment, surgical equipment and in vitro diagnostic equipment

The domestic products under Radiotherapy equipment is solely under 20% compared to imported products.

In the reports are also details about procurement of 3 tier hospitals, exact procured product and sum of typical medical device with name of manufacturers.

6.    Do you know that? Essential Facts about Medical Device Compliance

6.1  It is allowed to have eIFU in China. See the official answer here.

6.2  NMPA publishes every month approved medical device, see last publication. Actually there is also central database to search approved medical device.

6.3 Database of Chinese standard 

6.4 CMDE learning online 



6.5 Registration workflow 

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