Progress in FDA UDI System for Medical Devices and its Revelation for Coding of our Country
- VernacularTitle:美国医疗器械唯一标识(UDI)实施进展及对我国编码工作的启示
- Author:
Wanjuan YANG
;
Jun LI
;
Jingli LI
- Publication Type:Journal Article
- Keywords:
Medical device;
UDI;
FDA
- From:
China Pharmacist
2015;(1):142-144,145
- CountryChina
- Language:Chinese
-
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.