日本医疗器械良好实验室规范监管体系介绍及对我国的启示  

Introduction of GLP Regulatory System of Medical Devices in Japan and Its Implications for China

作　　者：陈鸿波[1] 杨婉娟[1] 李海宁[1] 章娜[1] 邱凡珊 李静莉[1] 王涵[1] CHEN Hongbo;YANG Wanjuan;LI Haining;ZHANG Na;QIU Fanshan;LI Jingli;WANG Han(National Institute for Food and Drug Control,Beijing,China 102629)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药业》2025年第7期1-4,共4页China Pharmaceuticals

基　　金：国家重点研发计划课题[2022YFC2409802]。

摘　　要：目的 为我国医疗器械良好实验室规范(GLP)的建设提供参考。方法 查阅相关文献,总结日本医疗器械的监管体系及医疗器械GLP的相关内容,分析我国医疗器械非临床安全性研究的现状及GLP建设面临的挑战。结果 GLP作为日本医疗器械非临床安全性研究的质量管理规范,保证了日本医疗器械临床前安全性试验结果的真实性和有效性。我国医疗器械非临床安全性研究主要按GB/T 16886系列标准进行安全试验,但尚无法律、法规、规章要求检验机构执行;检验机构一般按国际标准化组织/国际电工委员会(ISO/IEC)17025质量管理体系进行中国合格评定国家认可委员会(CNAS)认可。当前在我国建设医疗器械GLP还面临不少挑战,即没有相关法律法规要求;检验机构水平参差不齐,各机构的软硬件设施及发展水平差异较大,并非都能满足GLP建设的要求;企业需求复杂;实施医疗器械GLP会导致检验成本增加而增加企业负担,短期内不利于医疗器械生产企业的发展;多体系运行会给检验机构的检验工作带来一定困难。结论 我国可借鉴日本GLP的管理模式,对医疗器械的非临床安全性评价进行针对性管理,建立符合我国国情的医疗器械GLP管理制度,并推动国际互认。Objective To provide a reference for the construction of Good Laboratory Practice(GLP)for medical devices in China.Methods The relevant studies were reviewed to summarize the regulatory system and GLP-related content of medical devices in Japan.The current status of non-clinical safety research on medical devices in China and the challenges faced by GLP construction were analyzed.Results As a quality management standard for non-clinical safety studies of medical devices in Japan,GLP ensured the authenticity and validity of the results of pre-clinical safety trials for medical devices in Japan.The non-clinical safety research of medical devices in China mainly conducted safety tests according to the GB/T 16886 series standards,but there were no laws,regulations,or rules requiring inspection agencies to implement them.Inspection agencies generally followed the International Organization for Standardization/International Electrotechnical Commission(ISO/IEC)17025 quality management system for accreditation by the China National Accreditation Service for Conformity Assessment(CNAS).Currently,the construction of GLP for medical devices in China still faced many challenges,such as the relevant legal and regulatory requirements were insufficiency;the level of inspection institutions varied greatly,and the software and hardware facilities as well as development levels of each institution differ greatly,not all of which could meet the requirements of GLP construction;the demands of enterprises were complex;the implementation of GLP for medical devices would lead to an increase in inspection costs and burden on enterprises,which was not conducive to the development of medical device manufacturing enterprises in the short term;the operation of multiple systems brought some difficulties to the inspection work of inspection agencies.Conclusion China can learn from the management model of GLP in Japan,carry out targeted management of non-clinical safety evaluation of medical devices,establish a GLP management system for medical

关 键 词：良好实验室规范 日本 医疗器械 监管体系 

分 类 号：R95[医药卫生—药学]