国际医疗器械监管者论坛《唯一医疗器械标识系统》介绍及对我国启示

In this paper, based describing on the concept and its importance of unique medical device identification,it introduced the main content of the proposed rule about UDI System for Medical Device from International Medical Device Regulators Forum. The plan of the UDI system in our country should be proposed as soon as possible. It pointed out that the establishment of UDI system in China should be combined with UDI System for Medical Device from International Medical Device Regulator Forum and with other functions of the medical device regulatory affaires.