인공지능 기술 기반 의료기기 핵심 규제요소를 중심으로 한 국가별 규제체계 비교

초록

Artificial intelligence(AI)–based medical devices exhibit technical characteristics such as data dependency, and continuous learning, which challenge the regulatory frameworks developed for conventional software-based medical devices. This study aims to identify structural and operational regulatory gaps in Korea's regulatory system for AI-based medical devices by applying ISO/IEC international standards and International Medical Device Regulators Forum (IMDRF) guidelines as normative reference models. Through an analysis of the technical characteristics of AI–based medical devices and their associated risk across the total product life cycle, five key regulatory elements were derived: predetermined change control plans, real-world performance monitoring, explainability, data quality and fairness management, and AI-specific cybersecurity requirements. These elements served as an analytical framework to compare regulatory approaches in the United States and the European Union, with Korea as the primary subject of evaluation. The results indicate that, although Korea has established a legal foundation for regulating AI medical devices through the Digital Medical Products Act, critical operational criteria—particularly for post-market change management, real-world performance monitoring, data bias evaluation, and AI-specific cybersecurity—remain insufficiently specified. This study highlights the need for actionable, life-cycle–oriented regulatory mechanisms aligned with international standards to enhance regulatory predictability, consistency, and patient safety in governance of AI-based medical devices

키워드