摘要
目的:探索我国医疗器械标准的管理思路。方法:对国际医疗器械监管者论坛(IMDRF)“优化用于监管目的的标准”进行文献研究,并应用系统理论归纳其基本要求及逻辑结构。结果:“优化用于监管目的的标准”基本要求分为三方面内容,分别为通用要求及相关的定义,标准制定建议及如何加强利益相关者参与标准的制定。结论:IMDRF“优化用于监管目的的标准”在标准立项、起草、征求意见、实施评价及宣贯培训等方面对我国医疗器械标准管理具有指导意义,可参考具体要求加强对标准的管理。
Objective:To explore the management ideas of domestic medical device standards.Methods:Literature studies on the“Optimizing Standards for Regulatory Use”of the International Medical Device Regulators Forum(IMDRF),and apply system theory to summarize its basic requirements and logical structure.Results:The basic requirements of“Optimizing Standards for Regulatory Use”are divided into three aspects,which are general requirements and related definitions,recommendations for standards development,and enhancing stakeholder participation in standards development.Conclusion:IMDRF“Optimizing Standards for Regulatory Use”has guiding significance for the management of medical device standards in terms of standard establishment,drafting,soliciting opinions,implementing evaluation and training.Specific requirements can be referred to the management of standards.
作者
毛歆
柯林楠
韩倩倩
MAO Xin;KE Lin-nan;HAN Qian-qian(National Institutes for Food and Drug Control,Beijing 102629)
出处
《中国医疗器械信息》
2025年第9期24-27,共4页
China Medical Device Information
