中国食品药品监管Issue(6)：18-25,8.DOI:10.3969/j.issn.1673-5390.2025.06.003
关于真实世界研究在第二类医疗器械技术审评中的应用研究思考
Study on the Application of Real-World Studies in the Technical Evaluation of Class Ⅱ Medical Devices
摘要
Abstract
In recent years,real-world studies(RWS)of medical devices have received increasing attention.This paper briefly reviews the progress of RWS in the United States and the European Union,and analyzes the progress and challenges of pilot studies on imported products carried out in Lecheng Pilot Zone,Hainan.This paper focuses on how provincial drug regulatory authorities use real-world evidence(RWE)in the technical evaluation of Class Ⅱ medical devices,and offers considerations for advancing related research.关键词
第二类医疗器械/真实世界研究/真实世界数据/技术审评/临床评价Key words
Class Ⅱ medical devices/real-world study/real-word data/technical evaluation/clinical evaluation分类
医药卫生引用本文复制引用
朱文武,胡凯,夏建松,杨辉,齐伟明..关于真实世界研究在第二类医疗器械技术审评中的应用研究思考[J].中国食品药品监管,2025,(6):18-25,8.基金项目
浙江省药品监督管理局科技计划项目(2023043) （2023043）
