美国FDA有效实施医疗器械唯一标识(UDI)系统的经验启示

Effective Unique Device Identification (UDI) System Implementation: Experience of US FDA

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,已成为当前医疗器械监管的全球通用语言。2013年9月24日,美国食品药品管理局(Food and Drug Administratio,FDA)发布医疗器械唯一标识系统(unique device identification system,UDI system)最终规定并正式实施UDI,为各国以全球协调方式实施UDI提供了经验。本文将系统研究美国UDI发展沿革、法规体系、核心内容与工作进展,对美国UDI实施方案、发码机构、全球UDI数据库(GUDID)及应用情况进行介绍,为我国开展并推进UDI工作提供借鉴和思路。

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.On September 24,2013 US Food and Drug Administration(FDA)published the Unique Device Identification System Final Rule and initiated the UDI implementation which providing experience for countries to implement UDI in a globally coordinated approach.This paper will systematically study the US UDI regulatory system and its progress in UDI related work,introduce implementation plan,coding agency,Global Unique Device Identification Database(GUDID)with the intention to provide experience and ideas for China to carry out and promote its UDI work.