医疗器械不良事件监测法规浅析和展望  

Analysis and Prospect of Medical Device Adverse Event Monitoring Regulations

作　　者：黄伟俊 HUANG Wei-jun(Shanghai Drug and Medical Device Adverse Reaction Monitoring Center,Shanghai 200040)

机构地区：[1]上海市药品和医疗器械不良反应监测中心,上海200040

出　　处：《中国医疗器械信息》2024年第15期1-3,16,共4页China Medical Device Information

摘　　要：医疗器械不良事件是指已上市的医疗器械在正常使用情况下发生的,导致或者可能导致人体伤害的各种有害事件。医疗器械不良事件的报告应当遵循可疑即报原则,即当怀疑某一事件为医疗器械不良事件时,均可按照医疗器械不良事件进行上报。一般医疗器械不良事件包括伤害事件和故障事件。近年来,医疗器械的全生命周期管理在现代医疗体系中变得日益重要,我国医疗器械的质量监管也更加强调全生命周期的管理策略,科学化、法治化、国际化和现代化步伐不断加快,医疗器械风险监测预警能力稳步提升,积极推进医疗器械不良事件监测体系和能力建设。欧盟作为全球范围内经济高度发达的联盟体,医疗器械产业同样领跑全球。医疗领域的高速发展,离不开强力且科学的监管。文章旨在通过梳理近年来我国关于医疗器械不良事件监测的法规制度,对照欧盟相关法规制度进行分析,进而对医疗器械不良事件监测工作的未来发展提出思考与展望。Medical device adverse events usually refer to various harmful events that occur under normal use of marketed medical devices and cause or may cause human injury.The reporting of adverse events of medical devices shall follow the principle of suspicious reporting,that is,when an event is suspected to be an adverse event of a medical device,it can be reported as an adverse event of a medical device.Common medical device adverse events include injury events and failure events.In recent years,China has continuously strengthened the quality of supervision of medical devices througtout its whole life cycle,continued to accelerate the pace of scientificization,rule of law,internationalization and modernization,and actively promoted the monitoring system of adverse events of medical devices,steadily improved the risk monitoring and vigilance ability of medical devices.As a highly developed economic union in the world,the EU also leads the world in the medical device industry.The rapid development of the medical field is inseparable from strong and scientific supervision.This paper aims to sort out the regulations of China’s medical device adverse event monitoring system in recent years,carry our the comparative analysis with the relevant EU laws and regulations,and then put forward thoughts and prospects for the future development of medical device adverse event monitoring.

关 键 词：医疗器械不良事件监测 法规分析 思考展望 

分 类 号：R197.39[医药卫生—卫生事业管理]