Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government, Drug Administration of Xinjiang Production and Construction Corps:

For the implementation of the regulations on the supervision and administration of medical devices (state council order no. 739), according to the medical device registration and filing management method "(market supervision administration makes no. 47) and the measures for the administration of the registration and archival filing in vitro diagnostic reagents (market supervision administration makes no. 48), country organization revised approval" in the second category of medical device registration operation rules, Hereby issued and effective as of the date of issue. The Notice of THE FOOD and Drug Administration on Printing and Distributing the Operating Standards for The Registration and Approval of Category II Medical Devices in China (FOOD and Drug Administration (2014) No. 209) shall be abolished at the same time.

Appendix: Operation Specification for Registration and Approval of Category II Medical Devices in China

State Food and Drug Administration

November 2, 2021