Analyzing the development status of China’s medical device circulation market，the current situation of enterprise compliance operation and supervision，sorting out the current legal basis for supervision，and in accordance with the requirements of current laws and regulations，the author combines the work practice of recent 10 years to summarize and analyze the problems existing in the current compliance operation of medical device commercial circulation enterprises，and put forward regulatory countermeasures and suggestions，aiming at providing reference for improving the compliance operation and supervision of medical device commercial circulation enterprises and constantly standardizing the order of medical device circulation.