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Announcement on publishing the requirements for registration and application materials of medical devices and the format of approval certificates
Author：Guangzhou Medical Expo
Time：2021-11-09
Reader：449
In order to standardize the registration management of medical devices, According to the regulations on the supervision and administration of medical devices (Order No. 739 of the State Council) and the administrative measures for the registration and filing of medical devices (Order No. 47 of the State Administration of market supervision), the State Food and drug administration has organized and formulated the requirements for the registration and application materials of medical devices and the format of approval certificates (see the annex), which is hereby promulgated and shall come into force as of January 1, 2022. The announcement on publishing the requirements of medical device registration application materials and the format of approval documents issued by the former State Food and Drug Administration (Announcement No. 43 of the former State Food and Drug Administration in 2014) shall be repealed at the same time.
It is hereby announced.
Annex: 1 Medical device registration certificate of the people's Republic of China (format)
2. Change registration (filing) documents of medical devices of the people's Republic of China (format)
3. Approval opinion form for clinical trials of medical devices of the State Drug Administration (format)
4. Format requirements for medical device registration application materials and approval certificates
5. Requirements and description of medical device registration application data
6. Requirements and description of application materials for continued registration of medical devices
7. Requirements and description of medical device change filing / change registration application data
8. Requirements and description of application materials for clinical trial approval of medical devices
9. List of basic principles for safety and performance of medical devices
State Food and Drug Administration
September 29, 2021
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