Provinces, autonomous regions, municipalities directly under the Central Government Drug Administration:

       In order to do a good job in the inspection of the medical device registration quality management system, according to the "Medical Device Supervision and Administration Regulations", "Medical Device Registration and Filing Management Measures", "In Vitro Diagnostic Reagent Registration and Filing Management Measures" And other relevant laws and regulations, the National Bureau organized the revision of the "Domestic Class III Medical Device Registration Quality Management System Verification Procedures", which are hereby issued and will come into force on the date of promulgation. The former State Food and Drug Administration's "Notice on Printing and Distributing the Inspection Procedures for the Quality Management System of Class III Medical Devices in China (Provisional)" (Food and Drug Administration [2015] No. 63) shall be abolished simultaneously.

Comprehensive Department of the State Food and Drug Administration

February 9, 2022