Announcement of the State Food and Drug Administration on the Release of Inspection Points and Judgment Principles for medical device clinical trial Projects (No. 22, 2025)

Issue date：12th Mar., 2025

In order to standardize the clinical trial inspection work of medical devices, unify the inspection scope and judgment criteria, and improve the inspection quality of clinical trial items of medical devices, According to the Regulations on the Supervision and Administration of Medical Devices (Decree No. 739 of The State Council), the Measures for the Administration of Registration and Filing of Medical Devices (Decree No. 47 of the General Administration of Market Supervision), the Measures for the Administration of Registration and Filing of in vitro Diagnostic Reagents (Decree No. 48 of the General Administration of Market Supervision) and the Quality Management Standards for Clinical Trials of Medical Devices (No. 28 of 2022), etc., The State Food and Drug Administration organized the revision of the "Medical Device Clinical Trial Project Inspection Points and judgment Principles".

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