NMPA Notice On The Publication Of Guidelines For Quality Management System Audit Of Medical Device Registration

In order to do a good job of quality management system audit under medical device MAH (Market Authorization Holder) system and improve the QMS audit quality for medical device registration, NMPA issued Guidelines for Quality Management System Audit of Medical Device Registration (NMPA, No. 50, 2022) on October 10, 2022.

This guideline is applicable to the on-site audit of the quality management system for Class II and Class III medical device registration carried out by the medical device regulatory authorities.

This guideline has a total of 73 audit items, of which 32 are marked with “*” key items and 41 general items.

It covers the key contents of quality management system, registration audit requirements, self-test audit requirements, etc. At the same time the quality management system principles, institutions and personnel, plant, facilities and equipment, document management, design and development, procurement, production, quality control, commissioned production and product authenticity as the key contents of the audit are explained in details.

Compared with the 2020 version, this version has added GMP, GCP and self-test provisions, clarifies the requirements for commissioned production and clinical, and revises and removes some of the content for easier execution. BradyKnows elite team has rich experience in medical device quality management system audit, covering ISO 13485, FDA 21 CFR 820, ISO 11135, NMPA GMP etc. If you have any questions about the audit in China and NMPA overseas audit, please contact info@bradyknowsmedical.com.