Progress in FDA UDI System for Medical Devices and its Revelation for Coding of our Country / 中国药师

ABSTRACT

USA is the first country implementing the UDI program at national level,and the UDI rules and GUDID guidance have been issued by FDA recently to officially launch the implementation of UDI. The paper reviewed the advancement of UDI program,dis-cussed the framework of UDI system,analyzed the approaches of UDI implementation such as accredited issuing agencies and GUDID et al, and made some suggestions on the development of medical device coding system in our country.