Objective To analyze the problems existing in the inspection of clinical trial projects of medical devices in Hunan Province and provide references for the inspection work of clinical trials of medical devices.Methods Collected the inspection of medical device clinical trial projects of in Hunan Province completed by Hunan Drug Inspection Center in 2024,sort out the main problems ,analyzed the reasons and gave suggestions.Results By retrospective supervision and inspection, the clinical trial projects involving 11 products of 10 medical device manufacturers in our province were randomly checked, a total of 19 times, 9 inspection teams were sent, 74 inspectors were sent, and 109 problems were found.Conclusion Clinical trials of medical devices were systematic and scientific work, all parties involved, including sponsors, researchers, institutions, ethics committees, and drug regulatory departments, should work closely together and perform their respective duties to enhance the quality of clinical trials for medical devices and avoid risks.