In order to do a good job in inspecting the registration quality management system under the medical device registrant system and improve the quality of the inspection work of the medical device registration quality management system, the National Medical Products Administration has organized the revision of the Guidelines for Inspecting the Medical Device Registration Quality Management System (see the attachment) according to requirements in the Regulation on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council), the Measures for the Administration of Registration and Filing of Medical Devices (Order of State Administration for Market Regulation (No. 47)), the Measures for the Administration of Registration and Filing of In-Vitro Diagnostic Reagents (Order of State Administration for Market Regulation (No. 48)), and the Measures for Supervision and Administration of Medical Device Production (Order of State Administration for Market Regulation (No. 53)), which is hereby issued and comes into effect from the issue date. The Announcement on Issuing the Guidelines for Inspecting the Medical Device Registration Quality Management System (No. 19 of 2020) of the National Medical Products Administration shall be abolished at the same time. 

It is hereby announced.

Attachment: Guidelines for Inspecting the Medical Device Registration Quality Management System