医疗器械产品稳定性研究及审评思路  

Stability Research and Review Guidelines of Medical Device Products

作　　者：仲志真 段世梅 顾旸铭 ZHONG Zhizhen;DUAN Shimei;GU Yangming(Shanghai Medical Device and Cosmetic Evaluation and Verification Center,Shanghai 200020,China)

机构地区：[1]上海市医疗器械化妆品审评核查中心,上海200020

出　　处：《生物医学工程学进展》2024年第1期21-26,共6页Progress in Biomedical Engineering

摘　　要：目的通过回顾中国及美国与医疗器械稳定性研究有关的指导性文件和标准,指导医疗器械注册申请人在医疗器械全生命周期内结合风险管理开展产品稳定性研究活动,也为技术审评人员在审评相关内容时提供思路。方法从货架有效期、使用稳定性、运输稳定性3个方面论述稳定性研究的内容,针对每个方面提供验证方案的设计思路,并从审评的角度为注册申请人在注册申报时如何提交一套完整的、便于审评人员研判的研究资料提供建议。结果随着科技的发展,医疗器械的复杂性不断提高,因此产品稳定性研究是一个持续发展的过程,需要企业和审评人员用科学的方法进行研究与判定。Objective To guide medical device registration applicants to carry out product stability research activities combined with risk management in the whole life cycle of medical devices by reviewing the guiding documents and standards related to medical device stability research in China and the United States,and to provide ideas for technical reviewers when reviewing related content.Methods The contents of stability research were discussed from shelf life,use stability and transportation stability,and the design ideas of verification scheme were provided for each aspect.From the perspective of review,suggestions were provided on how to submit a complete set of research data which was convenient for reviewers to study and judge.Results With the development of science and technology,the complexity of medical devices is increasing,so product stability research is also a continuous development process,which requires enterprises and reviewers to use scientific methods for research and judgment.

关 键 词：产品稳定性研究 货架有效期 使用稳定性 运输稳定性 风险管理 

分 类 号：R197.39[医药卫生—卫生事业管理]