IMDRF个性化医疗器械术语解读  

Interpretation of Personalized Medical Device Terms Published by IMDRF

作　　者：闵玥 周雯雯 潘硕[1] 黄亦武[3] 刘斌[1] 卢忠 Min Yue;Zhou Wenwen;Pan Shuo;Huang Yiwu;Liu Bin;Lu Zhong(Center for Medical Device Evaluation of CFDA,Beijing 100081,China;National Medical Products Administration,Beijing 100053,China;Shanghai Municipal Food and Drug Administration,Shanghai 200003,China)

机构地区：[1]国家食品药品监督管理总局医疗器械技术审评中心,北京100081 [2]国家药品监督管理局,北京100053 [3]上海市食品药品监督管理局,上海200003

出　　处：《中国药事》2019年第1期41-44,共4页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划"个性化医疗器械的产品标准和规范研究"(编号2017YFB1104105)

摘　　要：目的:解读个性化医疗器械术语,为未来个性化医疗器械监管要求的建立提供参考。方法:本文主要介绍了国际医疗器械监管机构论坛(IMDRF)发布的《个性化医疗器械术语》指南,解读和对比定制式医疗器械、患者匹配医疗器械和适应性医疗器械三类个性化医疗器械。结果与结论:在医疗器械的设计、生产和使用环节,三类个性化医疗器械的个性化程度不同。Objective: To interpret personalized medical device terms in order to provide references for establishing regulatory requirements for personalized medical devices in the future.Methods: This article mainly introduced the Guidance of Personalized Medical Device Terms published by international medical device regulators forum(IMDRF) to interpret and compare three types of personalized medical devices,such as customized medical devices,patient-matched medical devices and adaptive medical devices.Results and Conclusion: The three types of personalized medical devices have different levels of personalization in the aspects of design,production and use.

关 键 词：个性化医疗器械 定制式医疗器械 患者匹配医疗器械 适应性医疗器械 

分 类 号：R95[医药卫生—药学]