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中国医药导刊 ›› 2020, Vol. 22 ›› Issue (10): 748-752.

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    

全球实施UDI经验下UDI数据载体的“标”与“识”

  姚辰   

  1. 珠海复旦创新研究院,广东 珠海 518057
  • 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

The "Marking" and "Identification" of UDI Data Carrier Under Global UDI Implementation Experience

  1. Zhuhai Fudan Innovation Research Institute, Guangdong Zhuhai 518057, 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(unique device identifier,UDI)是医疗器械产品的“身份证”,医疗器械国际性的通用语言;医疗器械唯一标识系统(unique device identification system,UDI System)建设是医疗器械智慧监管的基础。UDI法规的全面实施涉及企业编码、申报、UDI数据载体赋码及验证、数据共享及应用等各环节内容。其中,UDI 数据载体的牢固、清晰、可读对于生产企业是十分重要的环节,是实现医疗器械全生命周期有效实施UDI的关键。鉴于此,本研究拟通过概述全球实施UDI经验下UDI数据载体的“标”与“识”,探讨UDI数据载体赋码及验证的正确实施对企业的重要性,以期为各企业能精准有效实施UDI提供借鉴。

关键词: font-size:medium, ">医疗器械;医疗器械唯一标识;医疗器械唯一标识系统;赋码;识读

Abstract: Unique device identifier (UDI) is the "identity card (ID)" number of medical device products,and is the universal language of medical devices. The construction of the unique device identification system (UDI System) is the basis for intelligent supervision of medical devices. The full implementation of UDI regulations involves enterprise coding, declaration, UDI coding and verification, data sharing & application etc. Therefore, the stability, clarity and readability of UDI data carrier are very important links for manufacturers, and are the key to the effective implementation of UDI throughout the life cycle of medical devices. In view of this, this research intends to discuss the importance of correct implementation of UDI coding and verification to enterprises by summarizing the “marking” and “identification” of UDI data carrier under the experience of global UDI implementation, so as to provide reference for enterprises on accurate and effective implementation of UDI.

Key words: font-size:medium, ">Medical device; UDI; UDI system; Coding the marking; Identification

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