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

为做好医疗器械注册人制度下注册质量管理体系核查工作，提高医疗器械注册质量管理体系核查工作质量，根据《医疗器械监督管理条例》（国务院令第739号）及《医疗器械注册与备案管理办法》（市场监管总局令第47号）、《体外诊断试剂注册与备案管理办法》（市场监管总局令第48号）、《医疗器械生产监督管理办法》（市场监管总局令第53号）等要求，国家药品监督管理局组织修订了《医疗器械注册质量管理体系核查指南》（见附件），现予发布，自发布之日起实施。国家药品监督管理局《关于发布医疗器械注册质量管理体系核查指南的通告》（2020年第19号）同时废止。

特此通告。

附件：医疗器械注册质量管理体系核查指南（下载）

国家药监局

2022年9月29日