Medical device clinical trial institutions have been changed from qualification recognition to record management since 2018.Based on the data of medical device clinical trial institutions registration system on the website of National Medical Products Administration,statistical analysis was made on the registration of medical device clinical trial institutions,including institutions quantity,hospital classification,regional distribution,specialties and principal investigator in Zhejiang Province from January 1,2018 to September 30,2023.Still there is the existence of various problems concerning the current clinical trial institutions in Zhejiang Province,such as uneven distribution of registered institutions,improvement of management understanding,inadequate allocation of full-time staff,and insufficient personnel training.Aiming at promoting the high-quality development of medical device clinical trials in Zhejiang Province,it is suggested that medical device clinical trial institutions should ensure basic configuration,allocate full-time management personnel,strengthen personnel training,enhance knowledge structure of investigators,develop incentive rules,strengthen risk consciousness and whole process quality control,enlarge academic exchanges and cooperation,improve clinical research applications,and other improvement measures.