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。
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.
作者
高国彪
张世庆
闵玥
杨宇希
仉琪
刘英杰
GAO Guo-biao;ZHANG Shi-qing;MIN Yue;ZHANG Qi;LIU Ying-jie(Center for Medical Device Evaluation,NMPA)
出处
《中国食品药品监管》
2024年第5期4-9,共6页
China Food & Drug Administration Magazine
关键词
医疗器械
技术审评
审评标准
审评认可
监管信赖
medical devices
technical evaluation
evaluation standards
evaluation recognition
regulation reliance
