Practical Exploration and Constructive Consideration on Medical Device Common Evaluation Reliance
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.
medical devicestechnical evaluationevaluation standardsevaluation recognitionregulation reliance
国家科技期刊平台
NSTL
万方数据
