关键词: 医疗器械, 上市后, 全生命周期, 监测, 风险管理, 警戒制度, 体系文件

Abstract: Objective To analyze the core framework and practical requirements of documents concerning the medical device vigilance system so as to provide a reference for medical device vigilance. Methods Based on the recently released “Good Vigilance Practice for Medical Devices (trial)” and its supporting documents, the drafting background, core objectives, framework, and specific requirements of this series of documents were analyzed in general and their implications for the construction of China's medical device vigilance system in particular. Results and Conclusion The “Good Vigilance Practice for Medical Devices” and its supporting documents reflect the core concept about risk management throughout the lifecycle of medical devices in China's medical device vigilance. Their issuance means that China has established the initial framework of the medical device vigilance system, which provides clear institutional documents for the implementation of medical device vigilance in China. This is of great significance for improving China's medical device vigilance system and facilitating related work.

Key words: Medical Device, Post-Marketing, Life Cycle, Surveillance, Risk Management, Vigilance System, System Documents