소프트웨어 활용 체외진단 의료기기의 관리 및 규제 개선: 국내외 규제 비교를 통한 국내 규제 개선 방안

Abstract

This study compares and analyzes domestic and international regulations on the application of software in In Vitro Diagnostic (IVD) medical devices, proposing improvements for South Korea. The research examines regulatory sta- tuses in Europe, the United States, and Australia, identifying differences in regulatory approaches and definitions. Despite varying methods, all countries recognize the importance of software, though the regulatory scope differs. Considering the current domestic regulations, systematic improvements are essential for sustainable growth. This study suggests regula- tory enhancements and draft guidelines, emphasizing the need for ongoing monitoring and stakeholder input to develop practical solutions.