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KMID : 1137820230440010041
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의공학회지
2023 Volume.44 No. 1 p.41 ~ p.52
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A Study on the Improvement of Domestic Medical Device Classification System through the Analysis of Major Foreign Countries
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Son Ji-Min
You Kang-Hyeon
Kim You-Rim
Kwon Gyeong-Min
Lee Hui-Sung
Jang Won-Seuk
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Abstract
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With the international change in the medical device market owing to the development of innovative med- ical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with prod- uct establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.
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KEYWORD
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Medical device, Classification system, Medical device category, EMDN, FDA
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