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中国医药导刊 ›› 2020, Vol. 22 ›› Issue (10): 742-747.

所属专题: 医疗器械唯一标识专栏

• 医疗器械唯一标识 • 上一篇    下一篇

医疗器械唯一标识(UDI)系统发码机构研究

易力, 邵玉波, 余新华*   

  1. 中国食品药品检定研究院医疗器械标准管理研究所, 北京 102629
  • 收稿日期:2020-06-23 修回日期:2020-11-06 出版日期:2020-10-28 发布日期:2020-10-28

Study on the Code Issuing Agency in the Unique Device Identification (UDI) System

  1. Institute of Medical Device Standardization Administration, National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2020-06-23 Revised:2020-11-06 Online:2020-10-28 Published:2020-10-28

摘要: 医疗器械唯一标识系统(unique device identification system,UDI System)是当前医疗器械监管领域的热点。其中医疗器械唯一标识(unique device identifier,UDI)作为医疗器械产品的“身份证”,包括产品标识(UDI-DI)和生产标识(UDI-PI),是UDI系统实施中基础且关键的部分。发码机构是UDI唯一性的重要保证,在UDI系统实施中扮演着重要的作用。本研究梳理了美国、欧盟以及国内UDI系统法规对发码机构的要求以及发码机构相关重要国际标准,重点介绍了常用的发码机构及其编码标准的内容,提出了对医疗器械注册人/备案人选择发码机构的建议,为各方实施UDI系统提供了参考。

关键词: font-size:medium, ">医疗器械唯一标识;UDI系统法规体系和组织架构;UDI发码机构

Abstract: The unique device identification system (UDI System) is currently a hot spot in the field of medical device supervision. Among them, the unique device identifier (UDI) serves as the “identity card (ID)” number of medical device products, including device identifier (UDI-DI) and production identifier (UDI-PI), which is a basic and key part of the implementation of the UDI system. The code issuing agency is an important guarantee for the uniqueness of UDI and plays an important role in the implementation of the UDI system. In this study, the requirements of worldwide(U.S., EU and domestic) UDI system regulations and the relevant important international standards of code issuing agencies are sorted. The common used code issuing agencies of UDI system and their standards are introduced, and the suggestion for choosing the appropriate one is given. The article provides a reference for the related stakeholders to implement UDI system.

Key words: font-size:medium, ">UDI; UDI system regulatory system and organizational structure; UDI code issuing agency

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