International Forum on Medical Device Regulations 2025: EU MDR & MDSAP Compliance and Market Access Strategies

The National Institute of Medical Device Safety Information (NIDS) aims to provide the latest updates on EU MDR and MDSAP regulations through this international forum, and to explore pathways for the successful global market entry of Korean manufacturers by leveraging insights from foreign regulatory authorities, CE Notified Bodies, and leading industry association experts from key countries.
In particular, the forum will present a broad range of practical and actionable strategies for sustainable growth, including approaches for expediting regulatory approval and managing risks in the European, Canadian, and Australian markets, as well as certification pathways for AI-based medical devices from the perspective of MDR auditors.
We look forward to the active participation of professionals and stakeholders from across the medical device industry in this forum, which aims to transform the challenges posed by increasingly stringent international regulations into valuable opportunities for new growth strategies.