미국과 유럽의 AI 기반 의료기기 소프트웨어 규제제도 고찰과 국내 허가현황 분석

• 영문명: A Review of Regulatory Policies for AI-Enabled Software as a Medical Device in the United States and Europe and Approval Status in Korea
• 발행기관: 대한약학회
• 저자명: 송인명(Inmyung Song) 김동숙(Dong-sook Kim) 박지은(Ji-Eun Park) 김수진(Sujin Kim) 정연(Youn Jung) 박실비아(Sylvia Park) 강은정(Eunjeong Kang) 양보람(Bo Ram Yang) 최상은(Sang-Eun Choi)
• 간행물 정보: 『약학회지』제69권 제3호(2025년), 201~211쪽, 전체 11쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.06.30

국문 초록

Medical devices incorporating artificial intelligence (AI) technology have been actively developed, but they may pose risks to patient safety by providing misleading information. This study aims to review the status of AI-enabled medical devices approved in Korea and the regulatory frameworks of the United States and the European Union governing the devices to draw key lessons. To assess the current status of software as a medical device (SaMD) approved in Korea, a search for “software” was conducted on the Medical Device Safety Information website (mfds.go.kr) of the Ministry of Food and Drug Safety. The Food and Drug Administration employs a risk assessment approach to oversee all medical devices, including SaMD. The European Medicines Agency introduced the Artificial Intelligence Act to establish risk classification, transparency requirements, and human oversight provisions. As of September 1, 2024, a total of 1,513 software-based medical devices have been approved in Korea, of which only a small number are AI-enabled devices. The U.S. and the E.U. share concerns regarding transparency issues and potential risks associated with AI-enabled medical devices, and both regions follow a risk-based regulatory approach. As the number of AI-enabled medical devices is expected to grow both in Korea and internationally, a robust risk assessment approach should be regarded as a fundamental component of the regulatory framework to ensure patient safety.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

References

키워드

Artificial intelligence Medical device Regulation SaMD