| 崔乐,郭世富,刘可君.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[J].中国药事,2023,(4):382-388 |
| 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 |
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| DOI：10.16153/j.1002-7777.2023.04.003 |
| 中文关键词: 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 |
| 英文关键词: in vitro diagnosis medical devices classifi cation principles regulatory policy IMDRF |
| 基金项目: |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| Objective: To compare and analyze the diff erences 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 Classifi cation 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 diff erences in the scope of product application, classifi cation framework and classifi cation rules. Conclusion: A comprehensive and in-depth understanding of the international experience of advanced classifi cation and regulatory work could help to propose a more comprehensive, scientifi c and reasonable regulatory policy, with a view to effectively save regulatory resources and improve regulatory effi ciency |
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