A Study on the Establishment of Essential Medical Device System in Korea based on the Analysis of Essential Medical Device Management Systems in Major Countries

주요국의 필수의료기기 운영제도 분석을 통한 국내 필수의료기기 제도 수립 방안 연구

Global supply chain disruptions, exemplified by the COVID-19 pandemic, have underscored the necessity for a stable supply system for essential medical devices. While South Korea has a well-established management system for essential medicines, there is a lack of a system for medical devices critical to patient care. The high dependence on imported medical devices in South Korea may lead to potential disruptions in supply, which pose substantial social implications. This study conducts a comparative analysis of the advanced systems employed by the United States, the European Union, and Japan, with the aim of proposing the establishment of a management system for essential medical devices in South Korea. Based on this analysis, the study identifies key strategies for the designation and stabilization of the supply of medical devices and suggests directions for enhancing the resilience of the healthcare system and emergency response capabilities. This includes incorporating criteria for designating essential medical devices, implementing preemptive measures, and strengthening supply chain management within South Korea.