高质量发展下我国医疗器械不良事件监测面临的挑战与思考  

The Challenges and Reflections on Medical Device Adverse Event Monitoring in China under High-Quality Development

作　　者：王琪 唐楠 朱伯臣 连晓晓 薄文广[4] 吕昀 于卫红[6] WANG Qi;TANG Nan;ZHU Bo-chen;LIAN Xiao-xiao;BO Wen-guang;LV Yun;YU Wei-hong(Tianjin Adverse Reaction Monitoring Center for Drugs,Medical Devices and Cosmetics;Tianjin Medical Products Administration;Tianjin International Biomedical Joint Research Institute Co.,Ltd.;School of Economics,Nankai University;Tianjin University of Traditional Chinese Medicine;Tianjin Hospital)

机构地区：[1]天津市药品医疗器械化妆品不良反应监测中心 [2]天津市药品监督管理局 [3]天津国际生物医药联合研究院有限公司 [4]南开大学经济学院 [5]天津中医药大学 [6]天津市天津医院

出　　处：《中国食品药品监管》2023年第6期108-117,共10页China Food & Drug Administration Magazine

摘　　要：当前我国医疗器械不良事件监测的法规体系基本建立,监管规模日益增长,监测模式不断优化。但随着医疗器械产业的蓬勃发展,不良事件监测法规体系的细节仍有待完善,相关主体的激励约束机制需持续建设,人员、技术、资金等要素保障能力滞后,导致在实现长效监管、有效监管、高效监管方面还存在挑战。在高质量发展要求下,本文对有关法规、报告和调研问卷进行分析研究,提出医疗器械不良事件监测应以完善不良事件监测法律法规为基础、提升不良事件监测能力为关键、构建共建共治的社会大监测格局为支撑、强化不良事件监测要素保障为抓手的思考与建议,以期为医疗器械行业高质量发展提供参考。At present,the regulatory system of medical device adverse event monitoring in China is basically established,and the scale of supervision is expanding with continuous optimization of monitoring modes.However,with the vigorous development of the medical device industry,the details of the regulatory system for adverse event monitoring still need to be improved.The incentive and constraint mechanisms of relevant entities need to be continuously constructed,and the guarantee capabilities of personnel,technology,funds and other factors are lagging behind,resulting in challenges in achieving long-term,effective,and efficient supervision.In response to the requirement of high-quality development,this paper analyzes and studies relevant regulations,reports,and research questionnaires,and puts forward reflections and suggestions for medical device adverse event monitoring.These include improving the relevant laws and regulations as a foundation,enhancing the ability to monitor adverse events as a key factor,building a cooperative social monitoring framework as support,and strengthening the guarantee of adverse event monitoring elements as a grip.Hopefully,this paper can provide a reference for the high-quality development of the medical device industry.

关 键 词：医疗器械 不良事件 困境 思考 

分 类 号：R197.39[医药卫生—卫生事业管理]