Abstract: Objective To study the feasibility and importance of post-marketing active monitoring of medical devices in China based on the pilot vigilance of medical devices and to offer recommendations for active monitoring using new methods for medical device vigilance. Methods Based on the current methods for adverse event monitoring of medical devices, cases of research on active monitoring conducted at home and in the United States were analyzed while the applications of active monitoring in medical device vigilance were elaborated. Results As a new mean of medical device vigilance, active monitoring will play an important role in the field of post-marketing safety supervision of medical devices. Conclusion In order to adapt to new requirements for risk control over medical devices and draw on the experience of the United States in terms of regulation of medical devices, it is recommended that new methods for active monitoring of medical device vigilance be explored in China in order to continue to improve the effectiveness of risk monitoring of medical devices and ensure the safety of medical devices.

Key words: medical device, vigilance, active monitoring, post-marketing, risk monitoring, safety