医疗器械GLP与医疗器械生物学评价  

Medical Devices GLP and Biological Evaluation of Medical Devices

作　　者：王雪[1] 张旻[1] 宋捷[1] 王欣[1] 胡燕平[1] 李波[1] 王军志[1] 

机构地区：[1]中国药品生物制品检定所国家药物安全评价监测中心,北京100176

出　　处：《中国药事》2010年第8期817-821,共5页Chinese Pharmaceutical Affairs

摘　　要：目的论述在医疗器械生物学评价中实施GLP的重要性与必要性。方法介绍GLP的背景、历史、目的和适用范围、GLP对实验设施的要求;介绍国外医疗器械GLP的法规要求和国内现状,以及医疗器械GLP试验的范围。结果医疗器械GLP是国外在产品注册上的基本要求,但在我国尚未施行。结论我国施行医疗器械GLP是必然趋势,是实现产品注册与国际接轨的前提。Objective To discuss the importance and necessity of Good Laboratory Practice（GLP） in biological evaluation of medical devices.Methods Introducing GLP background,history,objective and applicable ranges,as well as GLP request to experimental facilities.Illuminate medical devices GLP regulatory requirements of overseas,comparing with its development in China,and some biological testes referred to in it.Results Applying GLP regulations to studies of medical devices is the basic requirement for products registration in international regulation,but GLP hasn＇t been carried out in China.Conclusion It is the main trend to apply GLP regulations to biological safety studies of medical devices,and is the premise to realize products registration meeting with international development.

关 键 词：医疗器械 GLP 生物学评价 

分 类 号：R955[医药卫生—药学]