美国医疗器械唯一标识(UDI)实施进展及对我国编码工作的启示被引量：13

Progress in FDA UDI System for Medical Devices and its Revelation for Coding of our Country

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摘要美国是首个在国家层面、由政府实施医疗器械唯一标识(UDI)项目的国家,美国食品药品管理局(FDA)于近期发布了UDI法规和UDI数据库指南等文件,正式启动了UDI实施工作。该文概述了美国UDI项目推进情况,研讨了美国UDI系统的具体实施方案,分析了UDI发证机构、全球UDI数据库等美国特色的UDI系统实现方式,提出了可供我国医疗器械编码工作借鉴的思路和方法。 USA is the first country implementing the UDI program at national level, and the UDI rules and GUDID guidance have been issued by FDA recently to officially launch the implementation of UDI. The paper reviewed the advancement of UDI program, dis- cussed the framework of UDI system, analyzed the approaches of UDI implementation such as accredited issuing agencies and GUDID et al, and made some suggestions on the development of medical device coding system in our country.

作者杨婉娟李军李静莉

机构地区中国食品药品检定研究院医疗器械标准管理研究所

出处《中国药师》 CAS 2015年第1期142-145,共4页 China Pharmacist

基金中国食品药品检定研究院中青年研究基金资助项目(编号:2012B11)

关键词医疗器械唯一标识美国食品药品管理局 Medical device UDI FDA

分类号 R951 [医药卫生—药学]

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参考文献7

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