欧盟体外诊断医疗器械分类监管体系变化与思考  

Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System

作　　者：周良彬[1] 崔乐 程娟 黄颖[2] ZHOU Liangbin;CUI Le;CHENG Juan;HUANG Ying(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou,510663;National Institutes for Food and Drug Control,Beijing,100050)

机构地区：[1]广东省医疗器械质量监督检验所,广州市510663 [2]中国食品药品检定研究院,北京市100050

出　　处：《中国医疗器械杂志》2021年第6期674-679,共6页Chinese Journal of Medical Instrumentation

摘　　要：分析对比欧盟新法规IVDR与旧指令IVDD及相关指南文件中IVD产品分类监管体系,探讨其中监管变革思路,为行业人员了解掌握新的欧盟IVD分类体系提供参考,以供我国进行中的分类管理改革工作作为借鉴。By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR,old IVDD and related guidance documents,concepts of related regulatory reforms were analyzed and explored,to provide references for industrial personnel to understand and master the new EU IVD classification system,and for China's ongoing classification management reform.

关 键 词：体外诊断器械 分类监管体系 法规 欧盟 

分 类 号：F203[经济管理—国民经济] R951[医药卫生—药学]