| UDI系统实施中确定生产标识组成的应用实践 |
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| 引用本文： | 易力,荆敏琪,余新华.UDI系统实施中确定生产标识组成的应用实践[J].中国医疗器械杂志,2021(1). |
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| 作者姓名： | 易力 荆敏琪 余新华 |
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| 作者单位： | 中国食品药品检定研究院医疗器械标准管理研究所 |
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| 摘 要： | 分析了生产标识的作用和有关国际法规,并根据我国的法规和产业现状,提出了医疗器械注册人/备案人确定生产标识组成的实践,为各方积极实施和应用医疗器械唯一标识提供了参考。
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| 关 键 词： | 医疗器械唯一标识 生产标识 生产日期 |
Application Practice to Determine Structure of UDI-PI in Implementation of UDI System |
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| YI Li,JING Minqi,YU Xinhua.Application Practice to Determine Structure of UDI-PI in Implementation of UDI System[J].Chinese Journal of Medical Instrumentation,2021(1). |
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| Authors: | YI Li JING Minqi YU Xinhua |
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| Affiliation: | (Institute of Medical Device Standardization Administration,National Institutes for Food and Drug Control,Beijing,102629) |
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| Abstract: | The purpose of UDI-PI and related international regulations/guidelines is analyzed.The application practice for the registrant/filing applicant to determine the composition of UDI is given.The article provides reference for the related stakeholders to implement UDI system. |
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| Keywords: | UDI UDI-PI date of manufacture |
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