Latest Regulations | Summary of Medical Device Regulations in June 2024

I. Announcement notices and regulatory documents for medical devices

1. Announcement of the National Medical Products Administration on Approving the Registration of 265 Medical Device Products (May 2024) (No. 74 of 2024)

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxpzhzhcchpgg/20240621151259165.html

Release time: 2024-06-21

2. Announcement on the issuance of "Key Points and Judgment Principles for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)"

https://www.cfdi.org.cn/resource/news/15978.html

Release time: 2024-06-14

3. Announcement of the National Medical Products Administration on the Issuance of the Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial) (No. 22 of 2024)

Release time: 2024-06-14

4. Announcement of the National Medical Products Administration on Cancellation of Registration Certificates for Four Medical Devices Including Cerebral Aneurysm Clip (No. 69, 2024)

Release time: 2024-06-03

II. Medical Device Regulation

1. Symposium on Consolidating and Improving Medical Device Safety (Southern Region) Held

Release time: 2024-06-20

2. Fundus lesion image-aided diagnosis software for ocular fundus lesions approved for marketing

https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20240619100221144.html

Release time: 2024-06-19

3. The second-quarter medical device regulatory risk consultation meeting will be held

https://www.nmpa.gov.cn/yaowen/ypjgyw/hyxx/ylqxhyxx/20240618120833126.html

Release time: 2024-06-18

The report meeting on the compliance management of online sales of medical devices was held in Beijing

https://www.nmpa.gov.cn/yaowen/ypjgyw/hyxx/ylqxhyxx/20240614175638121.html

Release time: 2024-06-14

5. Relevant information on medical device licensing and filing in each province (as of May 31, 2024)

Release time: 2024-06-13

6. Disposable radiofrequency atrial septal puncture needle approved for marketing

https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20240612090955118.html

Release time: 2024-06-12

7. The National Medical Products Administration deploys measures to strengthen the supervision of clinical trial institutions for medical devices

Release time: 2024-06-07

8. Record information of imported Class I medical device products in May 2024

https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20240605155718136.html

Release time: 2024-06-05