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
- 1. 国家药品监督管理局医疗器械技术审评中心
- 折叠
摘要
促进全球医疗器械监管信赖,是加强国际交流合作、推动全球医疗器械产业发展、满足公众可及性诉求的重要途径.本文聚焦全球医疗器械法规协调会医疗器械审评互信实践项目的成立背景、工作目标、主要内容等,探讨如何通过建立技术审评标准、推动审评认可、实现互信审批,促进全球医疗器械监管信赖.
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引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据