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| IMDRF医疗器械良好审查规范(GRRP)工作组协调性指南文件研究及思考 |
| Research and Reflection on the Coordinated Guidelines for Medical Devices Good Regulatory Review Practice (GRRP) Working Group of IMDRF |
| 投稿时间：2024-05-10 修订日期：2024-06-20 |
| DOI： |
| 中文关键词: 医疗器械合格评定机构 国际医疗器械监管机构论坛 良好审查规范 |
| 英文关键词: Medical device Conformity Assessment Body International Medical Device Regulators Forum Good Regulatory Review Practice |
| 基金项目: |
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| 摘要点击次数: 15 |
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| 中文摘要: |
| 目的：通过研究良好审查规范工作组及协调性指南文件要义,探讨医疗器械国际监管协调的发展与优势。方法：梳理GRRP工作组工作情况和指南文件主要内容,展示文件所汇集的国际经验和共识。 结果与结论：国际医疗器械监管机构论坛良好审查规范工作组从监管机构职责、合格评定机构作决策的结构和过程、产品安全有效等方面起草并发布的8个协调性指南文件,在我国完全实施,体现我国在国际监管协调方面的主动作为。 |
| 英文摘要: |
| Objective: Exploring the development and advantages of international regulatory coordination for medical devices by studying the essence of the Good Review Practice Working Group and Coordination Guidelines. Methods: Sort out the work situation of the GRRP working group and the main content of the guideline document, and showcase the international experience and consensus gathered in the document. Results and Conclusion: The International Forum on Good Review Standards for Medical Device Regulatory Agencies has drafted and released eight coordinated guidance documents from the perspectives of product safety and effectiveness, the structure and process of decision-making by conformity assessment agencies, and the responsibilities of regulatory agencies. These documents have been fully implemented in China, reflecting China"s proactive efforts in international regulatory coordination. |
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