글로벌 및 국내 규제기관의 의료기기 인재양성 교육체계 비교분석과 국내 개선방안 제안

Abstract

This study conducts a comparative analysis of the medical device talent development education systems of major regulatory agencies, including the FDA (USA), PMDA (Japan), Health Canada, and MFDS (Korea), and proposes improvements for Korea’s system based on the current workforce status and demand in the domestic bio-health industry. The analysis reveals that each country’s education system differs in terms of operating bodies, tailored programs for trainees, industry-academia-research collaboration, and approaches to international regulatory harmonization. The United States and Japan operate systematic, dedicated educational organizations with continuous online learning platforms and provide long-term programs closely linked to practical experience. In contrast, Korea’s education is dispersed across multiple departments and relies mainly on in-person training, limiting accessibility and practical, hands-on learning. Additionally, domestic programs lack direct education on international regulatory harmonization and global standards, focusing primarily on theory-based short- and mid-term courses. Based on these findings, this study recommends: establishing a continuous and autonomous online education platform, creating a dedicated educational department for systematic management, introducing practice-oriented programs in collaboration with regulatory agencies, and expanding education on international regulatory harmonization and global standards. These improvements are expected to foster highly skilled professionals with regulatory science expertise and practical capabilities, particularly as the industry shifts toward digital healthcare and AI medical devices.