Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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A Study on the Improvement of Domestic Medical Device Classification System through the Analysis of Major Foreign Countries

주요국의 의료기기 품목 분류체계 조사분석을 통한 국내 의료기기 품목 신설 및 세분화 연구

  • Ji Min, Son (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Kang Hyeon, You (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • You Rim, Kim (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Gyeong Min, Kwon (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Hui Sung, Lee (Medical Devices Policy Division, Ministry of Food and Drug Safety) ;
  • Won Seuk, Jang (Department of Medical Device Engineering and Management, Yonsei University College of Medicine)
  • 손지민 (연세대학교 의과대학 의료기기산업학과) ;
  • 유강현 (연세대학교 의과대학 의료기기산업학과) ;
  • 김유림 (연세대학교 의과대학 의료기기산업학과) ;
  • 권경민 (연세대학교 의과대학 의료기기산업학과) ;
  • 이희성 (식품의약품안전처 의료기기정책과) ;
  • 장원석 (연세대학교 의과대학 의료기기산업학과)
  • Received : 2023.01.31
  • Accepted : 2023.02.10
  • Published : 2023.02.28
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Abstract

With the international change in the medical device market owing to the development of innovative medical 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 product 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.

Keywords

Acknowledgement

본 연구는 2022년도 식품의약품안전처의 신기술 의료기기 안전규제관리기준 마련 연구의 지원을 받아 수행되었으며 이에 감사드립니다.

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