基于GS1标准的唯一器械标识(UDI)是实现医疗器械在全球范围全流程追溯的标准化信息工具。制定和实施医疗器械唯一标识的目标是加强医疗器械研制、生产、经营和使用环节的监督和管理,提高监督管理效能。UDI可以运用在生产、流通、库存管理、使用和上市后监管等领域。UDI的使用和推广能让监管方、生产企业、流通企业、医疗机构、医保支付方、患者受益。
<<GS1-based Unique Device Identity(UDI)is an informatic tool for tracking medical devices at all processes globally. The goal of establishing and applying UDI is to strengthen surveillance and managementof medical devices throughout its developing,manufacturing,logistic,and using process. UDI can be used in the field of production,circulation,stock management,usage,and post-market surveillance. The adoption of UDI can benefit regulators,manufacturers,distributors,healthcare providers,payers,and patients.
<<