In 2019，the new Regulation for the Monitoring and Reevaluation of Medical Deviation Events was formally implemented，and drug regulatory authorities at all levels actively promoted the promotion and training of laws and regulations，promoted the learning and understanding of the method，and continuously improved the understanding of the monitoring of adverse events，and improved the information level of monitoring of adverse events in medical devices，laying the foundation for the improvement of the monitoring of adverse events in China. In 2019，the number of adverse events of suspicious medical devices was 40.27 million by the provincial level，and 91.8 per cent of which were reported by Shandong province. We should recognize that the number of adverse events reporting products is not necessarily high risk，should be through the adverse events reporting collection，analysis，evaluation of a period of time product risk level，draw the development trend of product risk，find and confirm the existence of product risk，targeted risk control measures to achieve risk management effect.