中国药物评价2024，Vol.41Issue(2)：88-92,5.
我国增材制造个性化医疗器械上市前监管现状和挑战
Current Pre-Market Regulatory Situation and Challenges of Personalized and Additive-Manufactured Implant Devices in China
摘要
Abstract
Additive manufacturing of personalized medical devices is hot study area and one of the key points of regulatory scientific re-search.This article comprehensively reviews the current regulatory status of personalized medical devices in additive manufacturing in Chi-na,including regulatory requirements such as definition,regulatory mode and classification management,technical guidance and standard system.In addition,combined with the International regulatory research and technology development,this paper puts forward the new problems and challenges to provide reference for relevant personnel.关键词
增材制造/个性化医疗器械/上市前监管Key words
Additive manufacture/Personalized medical devices/Pre-market administration分类
医药卫生引用本文复制引用
闵玥,史新立..我国增材制造个性化医疗器械上市前监管现状和挑战[J].中国药物评价,2024,41(2):88-92,5.基金项目
国家重点研发计划(2017YFB1104105) （2017YFB1104105）
