국제의료기기규제당국자포럼(IMDRF) 기술문서의 규제적 의의와 산업적 영향 분석: 의료기기 규제 국제 조화를 중심으로

초록

This study aims to provide an in-depth analysis of the current status, future directions, and regulatory and industrial significance of the Technical Documents developed by the Working Groups of the International Medical Device Regulators Forum (IMDRF). As an international consultative body dedicated to lowering market entry barriers caused by disparate regulations among member states and achieving harmonization, the IMDRF establishes in fact global standards. Drawing on the official IMDRF website and recently published technical documents, this research systematically analyzes working items across eight key sectors, including Adverse Event Terminology (AET), Artificial Intelligence/Machine Learning (AI/ML), and Software as a Medical Device (SaMD). The findings confirm that IMDRF technical documents exert a substantial influence on medical device development and quality management systems (QMS), independent of whether they have been formally codified into law by individual member nations. Specifically, these documents contribute to streamlining multi-country licensing procedures, enhancing regulatory review efficiency, and ultimately strengthening product competitiveness. Based on this analysis, this study suggests that the domestic medical device industry and regulatory authorities must establish proactive response strategies, including the continuous monitoring of IMDRF trends and the preemptive adoption of these international technical standards.

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