주요국의 필수의료기기 운영제도 분석을 통한 국내 필수의료기기 제도 수립 방안 연구
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
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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 sys- tem for essential medicines, there is a lack of a system for medical devices critical to patient care. The high depen- dence 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 man- agement 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 direc- tions for enhancing the resilience of the healthcare system and emergency response capabilities. This includes incorporating criteria for designating essential medical devices, implementing preemptive mea- sures, and strengthening supply chain management within South Korea.
Abstract
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 sys- tem for essential medicines, there is a lack of a system for medical devices critical to patient care. The high depen- dence 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 man- agement 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 direc- tions for enhancing the resilience of the healthcare system and emergency response capabilities. This includes incorporating criteria for designating essential medical devices, implementing preemptive mea- sures, and strengthening supply chain management within South Korea.
참고문헌 (39)
- "Pharmaceutical Affairs Act"[URL]
- Medical Device Industry Survey, "Korea Health Industry Development Institute", KHIDI, ~ (2024)
- A Study on the Designation and Management of Medical Devices to Report the Discontinuation of Supply, "Ministry of Food and Drug Safety National Institute of Food and Drug Safety Evaluation", MFDS, ~ (2020)
- "Prioritizing medical devices" (2023)[URL]
- Critical Medical Device List: Summary and Recommendations Report, "U.S. Department of Health and Human Services", HHS, ~ (2023)
- U.S. Congress, "Coronavirus Aid, Relief, and Economic Security Act, Pub. L. No. 116–136, 134 Stat. 281", ~ (2020)
- "European Parliament and Council. Regulation (EU) 2017", 745 on Medical Devices (MDR), 2017
- OECD, "Securing Medical Supply Chains in a Post-Pandemic World. OECD Health Policy Studies" (2024), OECD Publishing
- Notice on Production and Import Suspension Reporting for Medical Devices, "Ministry of Food and Drug Safety (MFDS)", ~ (2024)
- 2024 Designated Medical Devices List for Reporting Discontinuation of Production and Import, "MFDS", ~ (2024)
- Research on selective application of reporting on details of supply of medical devices, "MFDS", MFDS, ~ (2023)
- Regulations on the Supply of Rare and Urgently Needed Medical Devices, "Ministry of Food and Drug Safety", ~, pp.Notification No. 2018-392 (2019)
- U.S. Congress, "Public Health Security and Bioterrorism Preparedness and Response Act of 2002", Public Law 107-188, ~ (2002)
- The Strategic National Stockpile:Overview and Issues for Congress, "Congressional Research Service", ~ (2023)
- "Executive Order 14001. Executive Order on a Sustainable Public Health Supply Chain", The White House, ~
- "Strategic stockpiling and management of essential medical devices in emergencies"[URL]
- "Risk assessment and manufacturer obligations for medical device supply chain shortages"[URL]
- Defense Production Act: Opportunities Exist to Increase Transparency and Identify Future Actions to Mitigate Medical Supply Chain Issues, "United States Government Accountability Office", GAO, ~ (2020)
- Anon, "Building Resilient Health Systems to Advance toward Universal Health in the Americas: Lessons from COVID-19", ~ (2022)
- European Commission, "RescEU – Strengthening European disaster management", ~
