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| 我国医疗器械唯一标识数据库及其应用的探讨 | |
| 引用本文： | 易力,李军,郭媛媛,余新华. 我国医疗器械唯一标识数据库及其应用的探讨[J]. 中国药事, 2021, 35(12): 1347-1351 |
| 作者姓名： | 易力 李军 郭媛媛 余新华 |
| 作者单位： | 中国食品药品检定研究院,北京 102629;国家药品监督管理局,北京 100037;国家药品监督管理局信息中心,北京 100044 |
| 摘 要： | 本文概括了我国医疗器械唯一标识数据库的特点,分析了我国医疗器械唯一标识数据库的核心数据项,提出了医疗器械注册人/备案人填写唯一标识数据库注意事项和关注点,为各相关方积极应用相关数据提供参考. |
| 关 键 词： | 医疗器械唯一标识 医疗器械唯一标识数据库 数据项 |
On the Unique Device Identification Database in China and Its Application |
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| Yi Li,Li Jun,Guo Yuanyuan,Yu Xinhua. On the Unique Device Identification Database in China and Its Application[J]. Chinese Pharmaceutical Affairs, 2021, 35(12): 1347-1351 | |
| Authors: | Yi Li Li Jun Guo Yuanyuan Yu Xinhua |
| Affiliation: | National Institutes for Food and Drug Control, Beijing 102629 , China;National Medical Products Administration, Beijing 100037 , China;Center of Information, National Medical Products Administration, Beijing 100044 , China |
| Abstract: | To summarize the characteristics of Unique Device Identification Database (UDID) in China and analyze the core data items of the unique identification database of medical devices in China. Precautions and concerns for the registrants/record holders to fill in the unique identification database were put forward, so as to provide references for the relavant parties to actively apply the relevant data. |
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