NEWS
Announcement on the issuance of guidelines for the preparation of annual self-inspection reports of the medical device quality management system (No. 13 of 2022)
Published Time：
2022-03-24
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 the revision of the "Annual Self-Inspection Report of the Medical Device Quality Management System". Guidelines, is hereby issued, and will come into force on May 1, 2022. The original State Food and Drug Administration's "Notice on Issuing Guidelines for Compiling Annual Self-inspection Reports on the Quality Management System of Medical Device Manufacturers" (2016 No. 76) shall be repealed at the same time.
announce.
State Food and Drug Administration
February 24, 2022
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