Medical device clinical trial quality management practices
On March 24, 2022, the State Food and Drug Administration and the National Health Commission issued an announcement on the "Good Management Practices for Clinical Trials of Medical Devices" (No. 28, 2022). In order to deepen the reform of the medical device review and approval system and strengthen the management of clinical trials of medical devices, this announcement is based on the "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 739) and the "Measures for the Administration of Medical Device Registration and Filing" (Order No. 739 of the State Council). No. 47), " "Registration and Filing Management Measures for In Vitro Diagnostic Reagents" (State Administration for Market Regulation Order No. 48), the State Food and Drug Administration, together with the National Health Commission, organized the revision of the "Quality Management Practices for Clinical Trials of Medical Devices" starting from May 1, 2022 Implementation.
