我国与国际医疗器械监管者论坛关于体外诊断医疗器械分类原则的对比分析  

Comparative Analysis of the Product Classification Principles of In Vitro Diagnostic Medical Devices between China and IMDRF

作　　者：崔乐 郭世富[1] 刘可君 Cui Le;Guo Shifu;Liu Kejun(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2023年第4期382-388,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:通过对我国和国际医疗器械监管者论坛(IMDRF)关于体外诊断医疗器械分类原则的研究,比较分析二者的异同点,思考监管政策的关注重点。方法:系统介绍我国《体外诊断试剂分类规则》和《体外诊断(IVD)医疗器械分类原则》(IMDRF/IVD WG/N64FINAL:2021)的相关内容,并进行对比分析。结果:二者在判定影响产品风险程度的主要因素时思路基本一致,但是在产品适用范围、分类框架和分类细则方面存在差异。结论:全面深入地了解国际先进分类监管工作经验,有助于提出更全面、科学、合理的监管政策,以期有效节约监管资源,提高监管效率。Objective:To compare and analyze the differences and similarities between China and International Medical Device Regulators Forum(IMDRF),based on the research on the classification principles of in vitro diagnostic medical devices,so as to consider the focus of regulatory policies.Methods:Systematically introduced the relevant contents of China's"In Vitro Diagnostic Reagent Classification Rules"and"Principles of In Vitro Diagnostic(IVD)Medical Devices Classification"(IMDRF/IVD WG/N64FINAL:2021),and conducted a comparative analysis.Results:Both China and IMDRF had the same idea in determining the main factors aff ecting product risk degrees,whereas there were differences in the scope of product application,classification framework and classification rules.Conclusion:A comprehensive and in-depth understanding of the international experience of advanced classification and regulatory work could help to propose a more comprehensive,scientific and reasonable regulatory policy,with a view to effectively save regulatory resources and improve regulatory efficiency.

关 键 词：体外诊断 医疗器械 分类原则 监管政策 国际医疗器械监管者论坛 

分 类 号：R95[医药卫生—药学]