Announcement On Issuing The Guideline On The Preparation Of Annual Self-Inspection Report On Medical Device Quality Management System (No. 13, 2022)

In order to strengthen the supervision over the production of medical devices and ensure the safety and effectiveness of medical devices, the National Medical Products Administration (NMPA) has organized the revision of the guideline on the Preparation of Annual Self-Inspection Report on Medical Device Production Quality Management System in accordance with Paragraph 2 of Article 35 in the Regulations on the Supervision and Administration of Medical Devices, which is hereby issued and will come into force as of May 1, 2022.