What are the regulations for conducting medical device clinical trials?

Yanxing Medical: Clinical trials of medical devices should be conducted in accordance with the requirements of the Code for Quality Management of Clinical Trials of Medical Devices, and in qualified clinical trial organizations. The production of clinical trial samples should comply with the relevant requirements of the medical device quality management system. Class III medical devices for clinical trials on human beings with high risk, should be approved by the CFDA. Clinical trial approval is required for the third class of medical devices catalog by the CFDA to develop, adjust and publish. Clinical trial approval refers to the CFDA according to the applicant's application, the proposed clinical trial of medical devices, the degree of risk, clinical trial program, clinical benefit and risk of comparative analysis of the report and other comprehensive analysis, in order to decide whether to agree to carry out clinical trials process. Clinical trials of medical devices should be implemented within 3 years after approval; if not implemented after the deadline, the original approval document is annulled, and if clinical trials are still required, a new application should be made.