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 the Reports on Details of Supply of Medical Device System Through Selective Application

선별적 적용을 통한 의료기기 공급내역보고 제도 개선 연구

  • Hyun Ju Jeong (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Soo Yeon Lim (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Ju Wan Kim (Medical Device Management Division, Ministry of Food and Drug Safety) ;
  • Won Seuk Jang (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Byeong-Ju Kwon (Department of Medical Device Engineering and Management, Yonsei University College of Medicine)
  • 정현주 (연세대학교 의과대학 의료기기산업학과) ;
  • 임수연 (연세대학교 의과대학 의료기기산업학과) ;
  • 김주완 (식품의약품안전처 의료기기관리과) ;
  • 장원석 (연세대학교 의과대학 의료기기산업학과) ;
  • 권병주 (연세대학교 의과대학 의료기기산업학과)
  • Received : 2023.09.15
  • Accepted : 2023.10.10
  • Published : 2023.10.31
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Abstract

The objective of this study is to identify the selective application targets for reporting on details of supply of class 1 and 2 medical devices as part of the improvement of the reports on details of supply of medical device system, and to analyze its effectiveness. Therapeutic materials covered by health insurance and secondhand medical devices were chosen based on the transparency of health insurance coverage and the management of medical device distribution. As a result, approximately 85% of groups can be excluded from the reporting requirements compared to reporting all items under Class 1 and 2 medical devices. This is expected to enhance the efficiency of supply reporting tasks. Additionally, the information on supply details managed by the regulatory authority can be utilized for statistical analysis and periodic monitoring, serving as fundamental data for the development of medical device-related policies and research in the field of medical devices.

Keywords

Acknowledgement

본 연구는 2022년도 식품의약품안전처의 의료기기 공급내역보고 선별적 적용 방안 마련 연구의 지원을 받아 수행되었으며 이에 감사드립니다.

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