医疗器械唯一标识（UDI）系统的政策理解和体会

摘要/Abstract

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”，是医疗器械管理重要基础性工作之一。2019年7月，国家药品监督管理局（以下简称“国家药监局”）、国家卫生健康委员会（以下简称“国家卫健委”）联合印发《医疗器械唯一标识系统试点工作方案》，标志着我国UDI系统试点工作正式启动。为更好地推进UDI系统试点工作，统一各方对UDI系统的正确认识与理解，促进共识，积累试点经验，本文结合自身工作，阐述对UDI系统的法规和相关标准理解，解读试点工作政策，并结合实践体会提出思考。

关键词: 医疗器械唯一标识系统（UDI）, 系统规则, 试点工作, 政策理解

Abstract: Unique device identifier（UDI） is the "ID card" of medical device products， which is one of the important basic works in medical device management. In July 2019， the National Medical Products Administration(NMPA) and the National Health Commission of the PRC issued the pilot program scheme of China Unique Device Identification System (UDI system)，which marks the official launch of the pilot work of the unique device identification system in China. In order to better promote the UDI system pilot work， clarify rule of the UDI system，unify understanding， reach cooperative consensus and accumulate experience， this paper expounds the understanding of UDI system and the policy on pilot work in the light of the rules and related standards and puts forward the thoughts from the practical experience.

Key words: Unique device identification（UDI） system, System rule, Pilot work, Policy understanding

. 医疗器械唯一标识（UDI）系统的政策理解和体会[J]. 中国医药导刊, 2019, 21(9): 516-520.

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