中国药业2025，Vol.34Issue(7)：1-4,4.DOI:10.3969/j.issn.1006-4931.2025.07.001
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
摘要
Abstract
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 devices that is in line with China's national conditions,and promote international mutual recognition.关键词
良好实验室规范/日本/医疗器械/监管体系Key words
GLP/Japan/medical device/regulatory system分类
药学引用本文复制引用
陈鸿波,杨婉娟,李海宁,章娜,邱凡珊,李静莉,王涵..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[J].中国药业,2025,34(7):1-4,4.基金项目
国家重点研发计划课题[2022YFC2409802]. （）
