Circular of the State Food and Drug Administration on Issuing the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (No. 50 in 2022)

In order to do a good job in the verification of the registration quality management system under the medical device registrar system and improve the quality of the verification of the medical device registration quality management system, in accordance with the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council), the Administrative Measures for the Registration and Filing of Medical Devices (Order No. 47 of the General Administration of Market Supervision), the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (Order No. 48 of the General Administration of Market Supervision) The Measures for the Supervision and Administration of the Production of Medical Devices (Order No. 53 of the State Administration of Market Supervision) and other requirements, the State Drug Administration has organized the revision of the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (see the annex), which are hereby promulgated and will be implemented as of the date of promulgation. The Notice of the State Drug Administration on Issuing the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices (No. 19 in 2020) shall be repealed at the same time.

It is hereby notified.

Appendix: Guidelines for Verification of Medical Device Registration Quality Management System

State Food and Drug Administration

September 29, 2022