Medical artificial intelligence product development and registration for the purpose of clinical trials in accordance with what management

Medical artificial intelligence product development and registration for the purpose of clinical trials should be managed in accordance with the "Code for Quality Management of Clinical Trials of Medical Devices" (State Food and Drug Administration Bureau Order No. 25). The specification aims to ensure that the process of clinical trials of medical devices is standardized, the results are scientific and reliable, and the rights and interests of the subjects and safety are protected. Before the clinical trial, the applicant should conduct sufficient research and development and testing of the product to ensure the safety and effectiveness of the product. During the clinical trial, the test program shall be reviewed and approved in accordance with the standardized requirements, and the trial process shall be supervised and managed to ensure that the trial data are true, accurate and complete. At the end of the trial, the applicant should analyze and evaluate the results of the trial and submit an application for registration to the regulatory agency.