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.