| 中国和美国UDI法规框架与实施分析 |
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| 引用本文： | 王丽,李强,王新茹,夏兵,马雪皎,黎聪,张培茗.中国和美国UDI法规框架与实施分析[J].医疗卫生装备,2022(1):6-10. |
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| 作者姓名： | 王丽 李强 王新茹 夏兵 马雪皎 黎聪 张培茗 |
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| 作者单位： | 河南省药品评价中心;河南省食品药品审评查验中心;上海健康医学院医疗器械学院 |
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| 摘 要： | 分析了中国和美国在医疗器械唯一标识(unique device identification,UDI)法规框架、发码机构、数据库、实施方式等方面的差异,指出了我国在发码机构退出机制以及初期实施UDI过程中部分企业存在对《医疗器械唯一标识系统规则》认识不足等问题并给出建议,为后续更深入开展UDI工作提供了建设性意见.
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| 关 键 词： | UDI 医疗器械监管 法规框架 UDI数据库 |
Analysis on framework and implementation of UDI regulations in China and the United States |
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| WANG Li,LI Qiang,WANG Xin-ru,XIA Bing,MA Xue-jiao,LI Cong,ZHANG Pei-ming.Analysis on framework and implementation of UDI regulations in China and the United States[J].Chinese Medical Equipment Journal,2022(1):6-10. |
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| Authors: | WANG Li LI Qiang WANG Xin-ru XIA Bing MA Xue-jiao LI Cong ZHANG Pei-ming |
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| Institution: | (Center for Drug Reevaluation of He'nan,Zhengzhou 450008,China;He'nan Food and Drug Evaluation and Inspection Center,Zhengzhou 450008,China;School of Medical Instrumentation,Shanghai University of Medicine&Health Sciences,Shanghai 201318,China) |
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| Abstract: | The differences between China and the United States in terms of the regulatory framework,issuing agencies,database and implementation methods of unique device identification(UDI)for medical devices were analyzed.The problems in the withdrawal mechanism of issuing agencies and the lack of understanding of the UDI rules by some enterprises during the initial implementation of UDI in China were pointed out and some suggestions were given for the promotion of UDI. |
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| Keywords: | unique device identification supervision and administration of medical devices regulatory framework UDI database |
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