关键词: 医疗器械, 上市后, 监测, 监管, 不良事件, 医疗器械警戒, 主动监测

Abstract: Objective To analyze the developments of the medical device vigilance system so as to provide a reference and guidance for the establishment of such a system in China. Methods The developments of the medical device industry, post-market supervision of medical devices in developed countries, and the evolution of pharmacovigilance in China were traced. On this basis, the need to establish a vigilance system of medical devices in China was elaborated in combination with the progress in our pilot programs concerning adverse event monitoring and vigilance in medical device. Results and Conclusion Medical device vigilance is critical to risk management throughout the lifecycle of medical devices. Amid such vigilance, efforts should be made to accelerate the transition from oversight of adverse events to medical device vigilance, establish a new framework for related vigilance, and enforce proactive risk monitoring, precise analysis, and effective management of medical device products, which will boost product innovation and industrial upgrading.

Key words: Medical Device, Post-Marketing, Surveillance, Supervision, Adverse Event, Medical Device Vigilance, Active Monitoring