In order to strengthen the supervision over medical device manufacturing and guarantee the safety and effectiveness of medical devices, according to Paragraph 2 of Article 35 in the Regulations on Supervision and Administration of Medical Devices, the National Medical Products Administration organized to revise the Guidance for the Preparation of Annual Self-Inspection Report of Medical Device Quality Management System, which are hereby issued, and should take effect on May 1, 2022. The Announcement on Issuing the Guidance for the Preparation of Annual Self-inspection Report for Quality Management System of Medical Device Manufacturers issued by former China Food and Drug Administration on April 20, 2016 ([2016] No.76) shall be abolished at the same time.