Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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Management and Regulatory Improvement of In Vitro Diagnostic Medical Devices Using Software: Proposals for Enhancing Domestic Regulations through Comparative Analysis of International Regulations

소프트웨어 활용 체외진단 의료기기의 관리 및 규제 개선: 국내외 규제 비교를 통한 국내 규제 개선 방안

  • Soo Yeon Lim (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)
  • 임수연 (연세대학교 의과대학 의료기기산업학과) ;
  • 권병주 (연세대학교 의과대학 의료기기산업학과)
  • Received : 2024.06.27
  • Accepted : 2024.08.05
  • Published : 2024.08.31
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Abstract

This study compares and analyzes domestic and international regulations on the application of software in In Vitro Diagnostic (IVD) medical devices, proposing improvements for South Korea. The research examines regulatory statuses in Europe, the United States, and Australia, identifying differences in regulatory approaches and definitions. Despite varying methods, all countries recognize the importance of software, though the regulatory scope differs. Considering the current domestic regulations, systematic improvements are essential for sustainable growth. This study suggests regulatory enhancements and draft guidelines, emphasizing the need for ongoing monitoring and stakeholder input to develop practical solutions.

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References

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