Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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Comparison and Analysis of the Operational Standards for Medical Device Testing Institutions in Korea and the United States

한국과 미국의 의료기기 시험 기관의 운영 기준 비교 분석

  • Yewon Baek (Department of Medical Device Engineering and Management, Yonsei University, College of Medicine) ;
  • Wonseuk Jang (Department of Medical Device Engineering and Management, Yonsei University, College of Medicine)
  • 백예원 (연세대학교 의과대학 의료기기산업학과) ;
  • 장원석 (연세대학교 의과대학 의료기기산업학과)
  • Received : 2025.02.26
  • Accepted : 2026.02.20
  • Published : 2026.02.28
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Abstract

As the medical device market continues to expand, regulatory requirements to ensure safety and performance have become increasingly stringent, highlighting the need for comparative analysis of operational standards for testing institutions. This study aims to examine and compare the operational standards of medical device testing institutions in Korea and the United States to identify structural differences in their regulatory systems. In Korea, the Ministry of Food and Drug Safety (MFDS) designates clinical trial institutions and testing and inspection institutions in advance under the Medical Device Act. Detailed requirements regarding personnel, facilities and equipment, and documentation are prescribed to ensure a minimum level of institutional competence through a pre-designation regulatory framework. In contrast, the United States operates a post-market-oriented oversight system. Clinical investigations are conducted under 21 CFR Part 812 without prior institutional designation, and regulatory compliance is verified through Institutional Review Board (IRB) review and FDA inspections. Similarly, testing laboratories operate under ISO/IEC 17025-based accreditation and the ASCA program, with regulatory authorities exercising oversight through recognition, auditing, and supervision rather than prior designation. These findings provide policy-relevant insights that may support the establishment of operational standards for newly designated medical device testing institutions and the improvement of existing regulatory frameworks.

Keywords

Acknowledgement

본 연구는 2024년도 식품의약품안전처 '의료기기 품질관리 국제기준 도입을 위한 기술지원' 연구의 지원을 받아 수행되었으며 이에 감사드립니다.

References

  1. https://www.khidi.or.kr/board?menuId=MENU03198&siteId=SITE00039&utm accessed on 10 February 2026.
  2. Choi HK, Baek YW, Noh SY, Kim HM, Jang WS. A Study on the Operational Guidelines of Medical Device Usability Evaluation Institutions. Journal of Biomedical Engineering Research. 2025;46(1):50-61. https://doi.org/10.9718/JBER.2025.46.1.50
  3. MFDS. Enforcement Rule of the Medical Devices Act. Annex 3 (Good Clinical Practice for Medical Devices). 2024. p.1-27.
  4. MFDS. Medical Devices Act. Article 10 (Approval, etc. of Clinical Trial Plans). 2025.
  5. MFDS. Announcement on the Designation Status of Medical Device Clinical Trial Institutions. 2025.
  6. MFDS. Medical Devices Act. Article 27 (Testing and Inspections). 2025.
  7. MFDS. Act on Testing and Inspection in the Food and Drug Industry. Article 2 (Definitions). 2025.
  8. MFDS. Announcement on the Designation Status of Medical Device Testing and Inspection Institutions. 2025.
  9. MFDS. Regulations on the Designation of Medical Device Clinical Trial Institutions. Annex 1 (Evaluation Checklist for the Designation Assessment of Medical Device Clinical Trial Institutions). 2017. pp.1-16.
  10. MFDS. Enforcement Rule of the Medical Devices Act. Article 24 (Standards for Conducting Clinical Trials). 2025.
  11. MFDS. Enforcement Rule of the Act on Testing and Inspection in the Food and Drug Industry. Annex 2 (Designation Requirements for Testing and Inspection Institutions). 2025. pp.1-8.
  12. MFDS. Regulations on Evaluation of Testing and Inspection Institutions in the Food and Drug Industry. Annex 4 (Quality Management Standards for Testing and Inspection Institutions). 2025. pp.1-14.
  13. MFDS. Guidelines for Quality Management Standards for Testing and Inspection Institutions. 2021. pp.1-109.
  14. FDA. Regulations on Investigational Device Exemptions (IDE); 21 CFR Part 812. 2025.
  15. FDA. Guidance for Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. 2009. pp.1-18.
  16. FDA. Guidance for The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. 2020. pp.1-49.
  17. MFDS. Act on Testing and Inspection in the Food and Drug Industry. Article 10 (Revocation of Designation of Testing and Inspection Laboratories). 2025.