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논문분류	춘계학술대회 초록집
제목	The Development History of Korean Mobile Hemodialysis Machines
저자	Jintae Lee
출판정보	2024; 2024(1):
키워드
초록	The Development History of Korean Hemodialysis Device Despite having a stable economic situation and a high level of a public insurance system, the local device industry is lagging behind other industries, and most medical devices imports from global leading countries. During the COVID-19, the supply chain disruption of major medical devices caused a lot of difficulties for patients and became a social issue about the national disaster-level. Therefore, the government focused on developing medical devices such as CRRT and Hemodialysis machines, Hemodialyzer, and securing local production technology. Through the PMDF, which is jointly organized by four ministries of government in May of 2020, they have conducted projects to support domestic medical device R&D, develop, medical care, advanced medical welfare. Based on this, we were selected as the first company in Korea to carry out national task projects for intensive care patients (CRRT), hemodialysis machines with RO system, and hemodialyzer. The projects are being conducted commercially by SYNOPEX INC. through industry-academia joint research with academic and clinical support from the Dept of Nephrology at Seoul National Univ Hospital. The development of a CRRT for acute, intensive patients began in Sep 2019, has been completed, and will approve MFDS in Q2 2024. Hemodialysis machines and Dialyzer were selected as new national projects in Sep 2022 and are being carried out according to the development schedule. Currently, the development of 11 types Dialyzer, Hemodialysis machines with RO system, which can be used in hospital isolation rooms or at home, has been underway at Seoul National Univ Hospital since Sep 2023, with the goal of registration end of 2025. In particular, the Dialyzer is being prepared for sale after receiving approval in Mar 2024. The year 2024 will be a meaningful year for the hemodialysis market in Korea, based on Korean produced hemodialysis devices.
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