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中国医药导刊 ›› 2020, Vol. 22 ›› Issue (3): 201-210.

所属专题: 医疗器械唯一标识专栏 智慧监管专栏

• 医疗器械唯一标识专栏 • 上一篇    下一篇

医疗器械唯一标识(UDI)系统实施探讨——基于GS1标准的应用实践

贾志涛   

  1. 中国物品编码中心, 北京 100011
  • 收稿日期:2020-04-20 修回日期:2020-03-23 出版日期:2020-03-31 发布日期:2020-05-14

Research on Implementation of Unique Device Identifier (UDI) System——Based on GS1 Global Standard

  1. GS1 China, Beijing 100011, China
  • Received:2020-04-20 Revised:2020-03-23 Online:2020-03-31 Published:2020-05-14

摘要: 医疗器械唯一标识(unique device identifier,UDI)是医疗器械唯一性识别码,是准确采集医疗器械全生命周期数据的基础,目前已成为解决医疗器械监管问题的全球通用语言。2019年我国关于UDI实施的医疗器械监管公共政策取得重大进展。国家药品监督管理局制定发布了《医疗器械唯一标识系统规则》,规定2020年10月1日起部分有源植入类、无源植入类等高风险第三类医疗器械将作为第一批医疗器械实施UDI。UDI是一个崭新且复杂的议题,在法规正式实施之前,医疗器械生产企业需要正确分配UDI,选择合适的载体,经营流通企业和医疗机构等相关参与方需要根据UDI使用需求更新相应的软硬件系统。本文拟从标准层面,介绍GS1标准与UDI的关系,以及基于GS1标准实施UDI的应用实践,围绕UDI实施过程中遇到的共性问题展开思考和探讨,以期为有效推进我国UDI系统的实施提供借鉴。

关键词: font-size:medium, ">医疗器械唯一标识;国际通用标准;GS1

Abstract: The unique device identifier (UDI) is the unique identification for a specific medical device. As the basis for accurately collecting data of medical devices in its life cycle, UDI has been recognized as the common language for medical device supervision worldwide. Significant progress on medical device public policy has been made in China in 2019, and the Unique Devices Identification Rules was formally published. Starting from October 1, 2020, some high-risk third-class medical devices will implement UDI as the first batch. UDI is a new and complex issue. Before the regulations are enforced, relevant parties such as medical device manufacturers, distributors, and healthcare providers need to understand and master the correct coding and assign of UDI, select the appropriate carriers, and update the corresponding software and hardware equipment as needed. This article introduces the relationship between the general international standards and UDI, and how to implement UDI based on the GS1 standards, and carry out discussion focus on the common problems encountered in the process of UDI implementation, with a view to providing reference for the effective promotion of the implementation of the current UDI system in China.

Key words: font-size:medium, ">Unique device identifier; Global standard; GS1

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