The Provisions for Monitoring and re-evaluating the Adverse Events of Medical Devices have been effective since January 1st，2019. In this article，the author introduced the development history and the achievements of the monitoring system about the adverse events of medical devices in China. At the same time，the author profoundly analyzed those problems which had been found during monitoring the adverse events and discussed how we should understand about the monitoring，supervision and administration of adverse events. In addition，the new requirements of the regulations and future work about adverse events monitoring were included in this article.