The implementation of medical device clinical trials was relatively backward in China，but it developed rapidly. In recent years，With the quantity increased significantly，more and more problems were arisen in medical device clinical trials. Therefore，the National Medical Products Administration had carried out a series of reform measures for it，and the regulation measures was becoming standardly and strictly. To provide reference for all parties involved in the implementation of clinical trials，this article summarizes and considers the current status of medical device clinical trial in China，involved in institution，supervision，quality control，risk management and current shortcomings.