인체삽입형 의료기기 추적관리를 통한 부작용 확산 최소화 방안에 관한 연구

Abstract

With the recent implementation of the Medical Devices Act ('19.7.), the registration of the medical device standard code (UDI) and integrated information became mandatory, laying the foundation for the people 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 to derive major initiatives for operating the optimal medical device integrated 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 discovery of new business.