Journal of Wellbeing Management and Applied Psychology (웰빙융합연구)

Korea Wellbeing Convergence Association (한국웰빙융합학회)
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Comparative Analysis of Medical Device Regulation in Korea and the United States

  • Soon-Gyu LEE (Dept. of Smart Manufacturing Engineering, Changwon National University) ;
  • Seong-Gyu AHN (Future New Industry Division, Changwon Special City) ;
  • Hong-Gyu PARK (Dept. of Electrical, Electronic, Control Engineering, Changwon National University) ;
  • Sang-Geon PARK (Dept. of Mechatronics Convergence, Changwon National University)
  • Received : 2025.11.11
  • Accepted : 2025.12.11
  • Published : 2025.12.30
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Abstract

Purpose: This study aims to compare the medical device classification systems and regulatory frameworks of Korea and the United States. By analyzing ten comparable device categories and adverse event reports, it examines the effectiveness and safety management levels of each country's regulatory system. Research Design, Data, and Methodology: This study conducted a comparative analysis using official regulatory and statistical data. In Korea, data were obtained from the MFDS and NIDS, while in the United States, FDA's MAUDE database was used. Population data from Statistics Korea were applied to calculate adverse event rates per total population. Results: A comparative analysis across 10 device categories revealed that the MFDS generally assigned a risk classification 1 class higher than the FDA for generally equivalent devices. From 2020 to 2024, the number of adverse reaction reports for Korean medical devices increased slightly by 3.2% (from 8,838 to 9,122), while the United States saw a 67% increase (from 1,567,545 to 2,628,663). In 2024, the adverse reaction reporting rate in the United States was approximately 40 times that of Korea. Conclusion: Research findings indicate that Korea's Class 4 regulatory framework is stricter than the U.S. Class 3 system in terms of ensuring safety and efficacy, resulting in a significantly lower number of adverse event reports. These results suggest that Korea's medical device regulations exert a certain degree of influence on industrial reliability and patient safety. This provides meaningful implications for future policy improvements and institutional development within the medical device industry.

Keywords

Acknowledgement

This work was supported by Innovative Human Resource Development for Local Intellectualization program through the Institute of Information & Communications Technology Planning & Evaluation(IITP) grant funded by the Korea government(MSIT)(IITP-2025-RS-2022-00156361) This work was supported by project for Collabo R&D between Industry, University, and Research Institute funded by Korea Ministry of SMEs and Startups in 2025.(RS-2025-02312566)

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