关键词: font-size:medium, ">医疗器械警戒；不良事件；风险信号；技术规范

Abstract: This study is based on the regulatory needs of the whole life cycle of medical devices， and systematically elaborates the core value of constructing the risk signal monitoring system of medical device adverse events from the perspective of standardisation. It addresses the problems of low awareness and consciousness， lagging behind in the construction of risk monitoring system， insufficient regulatory basis and lack of operability in the investigation， analysis and reporting of risk signals of adverse events in hospitals. Following the design principles of science， comprehensiveness， practicality and dynamics， the technical specification framework is constructed with 7 dimensions and 13 items. The results of the pilot implementation of the technical specification show that the effectiveness of risk management in hospitals has been significantly improved， and it is suggested to deepen the research on the universality of the technical specification， form a scalable solution， and provide a new tool for the technical governance of the post-market safety supervision of medical devices.

Key words: font-size:medium, ">Medical device vigilance；Adverse event；Risk signalling；Technical specification