中国食品药品监管Issue(5)：4-9,6.DOI:10.3969/j.issn.1673-5390.2024.05.001
医疗器械审评互信的实践探索和构建思考
Practical Exploration and Constructive Consideration on Medical Device Common Evaluation Reliance
高国彪 1张世庆 1闵玥 1杨宇希 1仉琪 1刘英杰1
作者信息
摘要
Abstract
Promoting global medical device regulatory reliance is an important approach to boost the development of the global medical device industry,strengthen international exchanges and cooperation,and meet the demands for public accessibility.This article focuses on the establishment background,objectives,main contents,etc.,of the Common Evaluation Reliance Practice(CERP)program of the Global Harmonization Working Party(GHWP).Moreover,it explores how to foster global reliance on medical device regulation by establishing technical evaluation standards,deepening recognition of evaluations,and achieving mutually reliable approvals.关键词
医疗器械/技术审评/审评标准/审评认可/监管信赖Key words
medical devices/technical evaluation/evaluation standards/evaluation recognition/regulation reliance分类
医药卫生引用本文复制引用
高国彪,张世庆,闵玥,杨宇希,仉琪,刘英杰..医疗器械审评互信的实践探索和构建思考[J].中国食品药品监管,2024,(5):4-9,6.
