Latest Regulations | Summary of Medical Device Regulations for May 2024

I、 Regulations and Interpretation

1.Notice of the National Medical Products Administration on the Implementation of the Classification Catalogue of In Vitro Diagnostic Reagents (No. 17 of 2024)

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20240511171642107.html

Release time：2024-05-11

2.Announcement of the National Medical Products Administration on Issuing the Classification Catalogue of In Vitro Diagnostic Reagents (No. 58 of 2024)

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20240511172028171.html

Release time：2024-05-11

3. Announcement of the National Medical Products Administration on Standardizing the Classification and Definition of Medical Device Products (No. 59 of 2024)

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20240511175941109.html

Release time：2024-05-11

4. Interpretation of the Classification Catalogue of In Vitro Diagnostic Reagents and the Notice on the Implementation of the Classification Catalogue of In Vitro Diagnostic Reagents

https://www.nmpa.gov.cn/xxgk/zhcjd/zhcjdylqx/20240511174202192.html

Release time：2024-05-11

5. Interpretation of the "Announcement on Regulating the Classification and Definition of Medical Device Products"

https://www.nmpa.gov.cn/xxgk/zhcjd/zhcjdylqx/20240511181125143.html

Release time：2024-05-11

6. Announcement of the National Medical Products Administration on Implementing Electronic Administrative Documents for Medical Device Registration (No. 68, 2024)

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20240531161900167.html

Release time：2024-05-31

II. Medical Device Regulation

1. Announcement of the National Medical Products Administration on Approving the Registration of 292 Medical Device Products (April 2024) (No. 56 of 2024)

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxpzhzhcchpgg/20240509163103133.html

Release time：2024-05-09

2. Relevant information on medical device licensing and filing in each province (as of April 30, 2024)

https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20240513141626151.html

Release time：2024-05-13

3. Record information of imported Class I medical device products in April 2024

https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20240515150735160.html

Release time：2024-05-15

4. Announcement of the National Medical Products Administration on Cancellation of Registration Certificates for Three Medical Devices Including Disposable Intravenous Blood Collection Needles（2024年第62号）

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20240517112317197.html

Release time：2024-05-17

5. Symposium on Strengthening and Improving Medical Device Safety (Eastern Region) Held

https://www.nmpa.gov.cn/yaowen/ypjgyw/hyxx/ylqxhyxx/20240517151128183.html

Release time：2024-05-17

6. The on-site meeting for the management of the national first-class medical device filing was held in Hangzhou

https://www.nmpa.gov.cn/yaowen/ypjgyw/hyxx/ylqxhyxx/20240524093222169.html

Release time：2024-05-24

7. Four innovative products, including implantable deep brain stimulation electrode lead kits, have been approved for market release

https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20240528154718191.html

Release time：2024-05-28

8. The National Medical Products Administration (NMPA) reports information on five cases of illegal and irregular online sales of medical devices (the sixth batch)

https://www.nmpa.gov.cn/yaowen/ypjgyw/ylqxyw/20240531110620158.html

Release time：2024-05-31

9. Pulmonary artery embolectomy stent system approved for marketing

https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20240531163405150.html

Release time：2024-05-31

10. The transjugular intrahepatic puncture device has been approved for marketing

https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20240531163609198.html

Release time：2024-05-31

III. Latest News from the Device Review Center

1. The Center for Medical Device Evaluation conducted a research visit to Shandong to investigate medical device innovation and regulatory work

https://wwwNaNde.org.cn/xwdt/zxyw/20240510140402152.html

Release time：2024-05-10

2. Notice on Publicly Soliciting Opinions on the "Guiding Principles for Registration Review of Pre-filled Catheter Flushing Devices (Draft for Comments)"

https://wwwNaNde.org.cn/xwdt/zxyw/20240511103135105.html

Release time：2024-05-11

3. Deepen reform, encourage innovation, and fully safeguard public health

https://wwwNaNde.org.cn/xwdt/zxyw/20240517085045187.html

Release time：2024-05-17

4. Comprehensively build a modernized review system for medical devices

https://wwwNaNde.org.cn/xwdt/zxyw/20240517090113179.html

Release time：2024-05-17

5. Informatization empowers medical device evaluation to improve quality and efficiency

https://wwwNaNde.org.cn/xwdt/zxyw/20240517091222142.html

Release time：2024-05-17

6. China's device review stimulates industrial innovation vitality through mechanism innovation

https://wwwNaNde.org.cn/xwdt/zxyw/20240517092202114.html

Release time：2024-05-17

7. Build a platform for industry-university-research exchange to promote high-quality industrial development

https://wwwNaNde.org.cn/xwdt/zxyw/20240517092836156.html

Release time：2024-05-17

8. Notice of the National Medical Products Administration's Center for Medical Device Evaluation on the Release of Guiding Principles for the Registration Review of 48 Medical Devices, Including Electric Photographic Flatbeds (No. 19 of 2024)

https://wwwNaNde.org.cn/xwdt/zxyw/20240527133331102.html

Release time：2024-05-27

9. Announcement of the Review Results for Special Review Applications for Innovative Medical Devices (No. 5, 2024)

https://wwwNaNde.org.cn/xwdt/zxyw/20240529143454168.html

Release time：2024-05-29