의료기기 표준코드(UDI) 제도의 해외사례 분석을 통한 통합정보시스템 구축 방안에 관한 연구

Abstract

With the recent implementation of the Medical Device Act(’19.7), the registration of medical device standard codes (UDI) and integrated information has become mandatory, enabling the public to use safer medical devices. In this paper, we analyzed the cases of overseas advanced countries of the medical device standard code system and drew implications, so presented major tasks for operating the optimal integrated medical device information system. If the application of each medical device class is spread based on the medical device integrated information system operation plan presented through this study, it is expected that the medical device industry will be revitalized, such as full-cycle safety management of medical devices and new business.