The drug administration of all provinces, autonomous regions and municipalities directly under the central government and the drug administration of Xinjiang production and Construction Corps:

In order to implement the requirements of the regulations on the supervision and administration of medical devices (Order No. 739 of the State Council), in accordance with the administrative measures for the registration and filing of medical devices (Order No. 47 of the State Administration of market supervision) and the administrative measures for the registration and filing of in vitro diagnostic reagents (Order No. 48 of the State Administration of market supervision), the State Administration has organized the revision of the operating specifications for the registration and approval of domestic class II medical devices , is hereby printed and distributed and shall go into effect as of the date of promulgation. The notice of the food and Drug Administration on printing and distributing the operation specifications for the registration and approval of domestic class II medical devices (sfyjxg [2014] No. 209) shall be abolished at the same time.

Annex: Code of practice for registration and approval of domestic class II medical devices国药监械注〔2021〕54号附件.docx

State Food and Drug Administration

November 2, 2021