The Comprehensive Department of the NMPA publicly solicits opinions on the Supervision and Inspection Points and Judgment Principles of Medical Device Clinical Trial Institutions (Draft for Comments)

Recently, in order to strengthen the management of medical device clinical trial institutions (hereinafter referred to as institutions) and standardize their supervision and inspection work, in accordance with relevant regulations such as the Management Measures for Medical Device Registration and Filing, the Management Measures for in vitro Diagnostic Reagent Registration and Filing, the Management Measures for Conditions and Filing of Medical Device Clinical Trial Institutions, and the Quality Management Standards for Medical Device Clinical Trials, the Comprehensive Department of the NMPA publicly solicits opinions on the Key Points and Judgment Principles for Supervision and Inspection of Medical Device Clinical Trial Institutions (Draft for Soliciting Opinions).

Watching focus

The inspection points shall apply to the supervision and inspection carried out by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central government within 60 days after the filing of the clinical testing institutions of medical devices. Daily supervision and inspection of clinical testing institutions for medical devices within the administrative region; And the State Medical Products Administration shall supervise and inspect clinical testing institutions for medical devices as required. The inspection points are divided into two parts: institution and clinical trial specialty, including 17 inspection links and 78 inspection items, including on-site inspection of conditions, record management and operation conditions.