The risk management of medical devices is related to its safety and has important significance. In 2018，adverse event report，supervision data，flight test data and sampling data of China’s medical device industry can show the current situation of risk management of medical devices in China. The changes of relevant regulations，supervision emphases and management standards of medical device risk management explain the supervision and technical change trend of risk management. The innovative development of medical device registrant system has brought new challenges to the risk management of medical devices.