General Department of the State Food and Drug Administration: printing and distributing the key points and judgment principles of clinical trials of medical devices

The inspection key points and judgment principles of clinical trials of medical devices are formulated in accordance with the requirements of the administrative measures for registration of medical devices and the quality management specifications for clinical trials of medical devices, which are used to guide the on-site inspection of clinical trials of medical devices 1、 Inspection points 2 Judgment principle: according to the problems found in the inspection, the inspection results shall be determined according to the following principles: (1) in case of any of the following circumstances, it is determined that there is a authenticity problem: 1 Fabricating the subject information, main test process records, research data, test data and other clinical test data, which affects the safety and effectiveness evaluation results of medical devices; 2 Clinical test data, such as inclusion exclusion criteria, main efficacy indicators and important safety indicators, cannot be traced; 3 The medical devices used in the test are not authentic, such as the medical devices used in the test are replaced by the control medical devices, the medical devices used in the test are replaced by the test medical devices, and the medical devices used in the false test are used in other ways; 4 Concealing the serious adverse events related to the clinical trial medical devices and the defects of the medical devices that may cause serious adverse events, the combination of drugs or medical devices whose use scheme is prohibited; 5 The data in the clinical trial report of registration application is inconsistent with the data in the clinical trial report kept by the clinical trial institution, which affects the safety and effectiveness evaluation results of the medical devices; 6 The data in the statistical analysis report of the clinical trial applied for registration is inconsistent with the data in the statistical database of the clinical trial or the data in the summary of the clinical trial of the sub center, which affects the safety and effectiveness evaluation results of the medical device; 7 Other circumstances that deliberately destroy the authenticity of the clinical trial data of the medical device （2） If no authenticity problem is found, but the clinical trial process does not meet the requirements of the relevant provisions of the clinical trial of medical devices, it is determined that there is a compliance problem （3） If the above problems are not found, it shall be determined as meeting the requirements.