Consolidated newsletter

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 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.

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

2. Guidances to develop and approve medical device

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

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.

Here last notification with some foreign manufacturer in Oct whose medical device in China was inspected and declared as non-conformity.

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.

5. News for Medical Devices

5.1 As of June this year, my country 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

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.