我国医疗器械GLP与医疗器械生物学评价研究.pdf.pdfVIP

2010 24 8 817 综 述 GLP 王 雪, 张 旻, 宋 捷, 王 欣, 胡燕平, 李 波, 王军志 ( , 100176) : 论述在医疗器械生物学评价中实施GLP 的重要性与必要性介绍GLP 的背景历史 目的和适 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 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 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 : 医疗器械; GLP ; 生物学评价 : R955 : A : ( 20 10) Medical Devices GLP and Biological Evaluation of Medical Devices Wang Xue, Zhang Min, Song Jie, Wang Xin, H u Y anping, Li Bo and Wang Junzhi ( National Cente fo Saf ety Evaluat ion of D ugs, Nat ional Inst itute fo the Cont ol of Pha maceutical and Biological P oducts, Beijing 100176) ABSTRACT: Objective T o discuss t he impo t ance and necessity of Goo d L abo at o y P act ice ( GLP) in biolog ical ev aluat ion of m edical devices Methods Int oducing GLP backg ound, hist o y , object iv e and applicable ang es, as w ell as GLP equest t o expe iment al f acilit ies Illum inat e medical devices GLP egulat o y equi em ent s of ove seas, compa ing w it h it s developm ent in China, and so me biolog ical t est es ef e ed to in it ResultsA pplying GLP egulat ions t o studies of medical devices is t he basic equi ement f o p oducts eg ist ation in int e nat ional eg ulat ion, but GLP hasnt been ca ied out in China ConclusionIt is t he main t end t o apply GLP eg ulat ions to bio logical saf ety studies of medical devices, and is t he p emise t o ealize p o duct s egist at ion meeting w ith int e nat ional development EYWORDS: medical dev ices; GLP; biolog ical evaluat ion GLP ! , [ 56] ISO 10993 GLP , GB/ T 16886 ,