In 2019，the State Drug Administration implemented the Regulation on the Supervision and Administration of Medical Devices，taking the reform of the system of examination and approval of medical devices as the main line，strengthening the construction of the legal system of medical devices，the foundation of registration management and the technical support system，speeding up the examination and approval of medical devices，which are urgently needed in clinical practice，and making new achievements in the management of medical devices registration. This paper introduces the achievements made in the reform of medical device examination and approval system in China in 2019，such as the system of medical device registration and regulation，medical device standard management，medical device classification and management，the improvement of the research of naming and coding technology，the strengthening of medical device clinical trial supervision，the comprehensive implementation of registration electronic declaration，the substantive development of international exchange and cooperation，etc.