Announcement on the Release of Guidelines for the Preparation of Annual Self-inspection Reports for Medical Device Quality Management Systems (No. 13 of 2022)

On 24 March 2022 the Chinese NMPA announced the release of guidelines on annual self-inspection reports for medical device quality management systems effective 1 May 2022.

In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, according to the second paragraph of Article 35 of the Regulations on the Supervision and Administration of Medical Devices, the State Drug Administration organized and revised the compilation of the annual self-inspection report on the medical device quality management system.