In order to effectively carry out the inspection of the quality management system for registration under the medical device registrant system and improve the inspection quality of the quality management system for medical device registration, in accordance with the Regulations on Supervision and Administration of Medical Devices (State Council Decree No. 739), Provisions for Medical Device Registration and Filing (SAMR Decree No. 47), Provisions for In-vitro Diagnostic Reagent Registration and Filing (SAMR Decree No. 48), Provisions for Supervision and Administration of Medical Device Manufacturing (SAMR Decree No. 53) and other requirements, NMPA has organized to revise the Guidelines for the Inspection of the Quality Management System for Medical Device Registration (see the Attachment), which is hereby issued and shall take effect as of the date of issuance. The NMPA Announcement on Issuing the Guidelines for the Inspection of the Quality Management System for Medical Device Registration (2020 No. 19) shall be abolished simultaneously.

　　Attachment: Guidelines for the Inspection of the Quality Management System for Medical Device Registration (to be translated)

　　The NMPA

　　September 29, 2022