| 闵玥,张家振,刘英慧,刘斌.医疗器械形式审查和技术审评比较研究[J].中国药事,2017,(11):1243-1248 |
| 医疗器械形式审查和技术审评比较研究 |
| A Comparative Study of Acceptance Review and Technical Review in Medical Device Review and Approval Process |
| 投稿时间：2017-02-27 |
| DOI：10.16153/j.1002-7777.2017.11.004 |
| 中文关键词: 医疗器械 上市前注册 形式审查 技术审评 |
| 英文关键词: medical device pre-market regulation acceptance review technical review |
| 基金项目: |
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| 中文摘要: |
| 目的：分析国内外医疗器械上市前注册中的形式审查和技术审评的要求，为医疗器械审评审批改革提供参考。方法：对比分析我国医疗器械形式审查环节和技术审评环节的工作内容、目标、操作流程和要求。同时，介绍美国FDA形式审查的内容和方式。结果：建立详细的审查清单，有助于明确和公开形式审查与技术审评的职责和要求。结论：医疗器械形式审查和技术审评的相关要求基本满足现有审评审批制度的需要，流程优化和质量提高方面仍有提升空间。 |
| 英文摘要: |
| Objective: In order to provide references for the reform of medical device pre-market review and approval process. Methods: This article compares the similarities and differences of current medical device acceptance review and technical review on workflow, objectives and requirements in China. And it also introduces steps and requirements of acceptance review in U. S.. Results: The use of review checklist could help identify and clarify the responsibilities and requirements of acceptance review and technical review process. Conclusion: The relevant requirements of medical device acceptance review and technical review basically meet the needs of the existing review and approval system, but there is still room for improvement in process optimization and quality improvement. |
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