대한의용생체공학회:의공학회지 (Journal of Biomedical Engineering Research)

  • 제45권4호
  • /
  • Pages.148-161
  • /
  • 2024
  • /
  • 1229-0807(pISSN)
  • /
  • 2288-9396(eISSN)
대한의용생체공학회 (The Korean Society of Medical and Biological Engineering)
권호 표지
DOI QR코드

DOI QR Code

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

Management and Regulatory Improvement of In Vitro Diagnostic Medical Devices Using Software: Proposals for Enhancing Domestic Regulations through Comparative Analysis of International Regulations

  • 임수연 (연세대학교 의과대학 의료기기산업학과) ;
  • 권병주 (연세대학교 의과대학 의료기기산업학과)
  • 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)
  • 투고 : 2024.06.27
  • 심사 : 2024.08.05
  • 발행 : 2024.08.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

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.

키워드

참고문헌

  1. In Vitro Diagnostic Medical Device Act. 2024 
  2. Lee, Sangwoo, ed. '2020 In Vitro Diagnostic Medical Device Policy Trends Report'. Seoul: Korea Medical Device Safety Information Bureau; 2020. pp. 1-305. Accessed at http://www.nids.or.kr on 12 Feb 2024. 
  3. Ministry of Food and Drug Safety. Analysis Report on Prospects for Newly Developed Medical Devices 2020. 2020. 
  4. Christodouleas DC, Kaur B, Chorti P. From Point-of-Care Testing to eHealth Diagnostic Devices (eDiagnostics). ACS Cent Sci. 2018;4(12):1600-1616.  https://doi.org/10.1021/acscentsci.8b00625
  5. Medical Device Act. 2024. 
  6. Jeong, Ho-sang. Study on the Foundation for Evaluation of New Technology In Vitro Diagnostic Products Including Standalone Software. Ministry of Food and Drug Safety. 2020. 
  7. Guidelines for Approval Review of Artificial Intelligence-Based Pathological Diagnosis (Breast Cancer) In Vitro Diagnostic Medical Device Software. 2022. 
  8. Guidelines for Approval Review of Medical Device Software. 2023. 
  9. Korea Medical Device Safety Information Bureau. Innovation Medical Device R&D Information Vol. 2 Innovation Diagnostic Kits, June 2021. 
  10. Ministry of Food and Drug Safety. Regulation on Items and Grades of In Vitro Diagnostic Medical Devices. 2021. 
  11. https://emedi.mfds.go.kr/search/data/MNU20237 Accessed on 14 April 2024. 
  12. https://www.yakup.com/news/index.html?mode=view&-cat=12&nid=286541 Accessed on 3 March 2024. 
  13. Wang, Seung-hye. "Analysis of EU Medical Device Legislation." Latest Foreign Legal Information; Issue Brief on Foreign Laws, Vol. 17-08, pp. 71-99, 2017. 
  14. MDCG (2019), Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 - MDR and Regulation (EU) 2017/746 - IVDR. 
  15. U.S. Food and Drug Administration. Available from: www.fda.gov. 
  16. https://www.meddeviceonline.com/doc/does-the-fda-or-eu-ivdr-consider-ivd-software-an-ivd-medical-device-0001 Accessed on 3 March 2024. 
  17. U.S. Food & Drug Administration. Clinical Decision Support Software-Guidance for Industry and Food and Drug Administration Staff. 2022. 
  18. Therapeutic Goods Administration, Classification of IVD medical deivces, 2020. 
  19. Therapeutic Goods Administration, Software as in vitro diagnostic medical devices. 
  20. Mantovani A, et al. Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: current scenario and challenges. Front Med Technol. 2023;5:1101476. 
  21. https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests Accessed on 15 march 2024. 
  22. Lee JS, Kim S. A Comparative Study on Innovative Medical Device Management Systems in Major Countries. Journal of Biomedical Engineering Research, 2022 Jun 30;43(3):153-60. https://doi.org/10.9718/JBER.2022.43.3.153