In Korea, the medical device approval certificate serves both as legal evidence of regulatory approval and as a means of managing detailed technical information on approved devices. This study investigated medical device approval systems in the United States, the European Union (EU), Japan, and Korea and compared approval-related documents, their information elements, and corresponding post-market management systems. The regulatory and post-market functions of individual information elements were comparatively evaluated based on relevant laws, regulations, and guidelines, including the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), the EU Medical Device Regulation (MDR), Japanese regulations and guidelines issued by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), and Korean medical device regulations. In the U.S., legally effective authorization or clearance documents are separated from documents containing detailed technical information, while summaries of safety and effectiveness information supporting regulatory decisions are separately provided. In the EU, no government-issued approval certificate equivalent to the Korean certificate exists; instead, Notified Bodies (NBs) issue certificates for devices requiring their involvement in conformity assessment under the MDR. In Japan, approval documents are relatively concise, with regulatory information supplemented by review reports, electronic instructions for use (eIFU). In contrast, Korea incorporates extensive regulatory and technical information directly into the approval certificate. Korea should therefore consider simplifying approval certificates while maintaining their essential legal functions and improving information accessibility, administrative efficiency, transparency, and alignment with international regulatory frameworks.