国内外医疗机构自制试剂监管政策发展历史与借鉴  

Regulatory Oversight of Self-made Reagents in Medical Institutions in China and Abroad:History and Lessons

作　　者：周良彬[1] 李伟松[1] 黄颖[2] ZHOU Liang-bin;LI Wei-song;HUANG Ying(Guangdong Medical Devices Quality Surveillance and Test Institute;National Institutes for Food and Drug Control)

机构地区：[1]广东省医疗器械质量监督检验所 [2]中国食品药品检定研究院

出　　处：《中国食品药品监管》2022年第5期84-93,共10页China Food & Drug Administration Magazine

摘　　要：本文对比我国、欧盟、美国医疗机构自制试剂监管历史及现行监管政策,从产品管理和使用管理两个不同角度分析国内外相关监管制度沿革,为行业人员系统了解国内外医疗机构自制试剂监管历史和现状提供索引,为我国正在制定的相关管理规定提供研究基础和参考。By comparing the regulatory history and current policies for self-made reagents in medical institutions in China,the European Union,and the United States,this paper analyzes the evolution of relevant domestic and foreign regulatory systems from the perspectives of product management and use management,hoping to provide an overview of the history and current status of regulatory oversight of self-made reagents in medical institutions for industry and to offer useful lessons for regulators in their efforts to formulate relevant policies in China.

关 键 词：医疗器械监督管理 体外诊断试剂 医疗机构自制试剂 

分 类 号：R95[医药卫生—药学]