UDI系统实施中确定生产标识组成的应用实践

Application Practice to Determine Structure of UDI-PI in Implementation of UDI System

摘要: 分析了生产标识的作用和有关国际法规，并根据我国的法规和产业现状，提出了医疗器械注册人/备案人确定生产标识组成的实践，为各方积极实施和应用医疗器械唯一标识提供了参考。

Abstract: The purpose of UDI-PI and related international regulations/guidelines is analyzed. The application practice for the registrant/filing applicant to determine the composition of UDI is given. The article provides reference for the related stakeholders to implement UDI system.