IMDRF“医疗器械注册申报资料规范”比较研究及评价

发布时间：2018-08-11 21:41

【摘要】：目的研究国际医疗器械监管机构论坛(international medical device regulators forum,IMDRF)医疗器械注册申报资料规范,为完善我国医疗器械上市前审查工作提供参考。方法对医疗器械注册申报资料规范项目(regulated yroduct submission,RPS)进行文献研究,并与注册申报资料规范(summary technical documetation,STED)、我国要求进行比较研究。基于分工原则、行政许可效率、便民原则和系统关联原则,对医疗器械注册申报资料规范进行理论分析和评价。结果医疗器械注册申报资料规范有利于提升医疗器械上市前审查的审查能力、审查效率和审查系统性。结论我国应实施医疗器械注册申报资料规范提出的新要求。我国医疗器械注册信息化管理水平低是实施RPS项目的主要困难,建议通过跟踪学习发达国家经验、明确立法地位和建立医疗器械技术审评信息系统3个方面加以应对。
[Abstract]:Objective to study the data standard of medical device registration and application of (international medical device regulators forumn IMDRF, and to provide reference for improving the pre-market review of medical device in China. Methods A comparative study was carried out between (regulated yroduct documents and (summary technical docuation data (summary technical). Based on the principle of division of labor, the efficiency of administrative license, the principle of convenience and the principle of system association, this paper makes a theoretical analysis and evaluation of the data standard of medical device registration. Results the standard of medical device registration and declaration is helpful to improve the ability, efficiency and systematicness of medical device pre-market examination. Conclusion our country should implement the new request of medical device registration data standard. The low level of information management of medical device registration in China is the main difficulty in the implementation of RPS project. It is suggested that three aspects should be taken to deal with this problem by following up the experiences of developed countries, clarifying the legislative status and establishing a medical device technical evaluation information system.
【作者单位】：沈阳药科大学工商管理学院;辽宁省药械审评与监测中心;国家食品药品监督管理总局;
【基金】：辽宁省社会发展攻关计划资助项目(2011225028)
【分类号】：R951

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