As an important means of implementing post market supervision and ensuring the safety of public use of medical devices,adverse event monitoring of medical devices is an important component of medical device safety supervision.In 2018,the State Administration for Market Regulation and the National Health Commission issued the"Management Measures for Monitoring and Re evaluation of Adverse Events in Medical Devices",which requires the establishment of a national medical device adverse event monitoring information system to promote the development of legal,standardized,and information-based construction of medical device adverse event monitoring work.In recent years,legal and regulatory requirements were actively responded to by medical device manufacturing enterprises,regulatory departments,and institutions,gradually emphasizing and optimizing adverse event monitoring work,and effectively controlling medical device risks.In this study,with selection of 50 medical device manufacturing enterprises in Jiangsu Province for on-site inspections,adverse event reports from these 50 enterprises were collected and analyzed.With the focus on the problems in monitoring adverse events of medical devices,corresponding countermeasures were proposed to ensure the safety of public use of medical devices.
关键词
医疗器械/生产企业/不良事件监测/江苏省/医疗器械监管/对策
Key words
Medical devices/Production enterprises/Adverse event monitoring/Jiangsu Province/Medical device supervision/Countermeasure
维普
万方数据