South Korea's Game-Changing 2025 Digital Medical Products Act
Medical Device Global Market Access · Pure Global
August 24, 20253m 26s
Audio is streamed directly from the publisher (episodes.captivate.fm) as published in their RSS feed. Play Podcasts does not host this file. Rights-holders can request removal through the copyright & takedown page.
Show Notes
This episode unpacks South Korea's pioneering Digital Medical Products Act (DMPA), set to revolutionize the regulatory landscape in January 2025. We explore the act's core components, including its new classification system for digital therapeutics and AI-driven software, the tailored approval processes, and what these changes mean for manufacturers seeking market access.
Key Questions:
• What is South Korea's new Digital Medical Products Act (DMPA)?
• Why is it considered the first comprehensive law of its kind globally?
• How does the DMPA classify different types of digital health products like AI and DTx?
• What new approval pathways will manufacturers need to navigate starting in 2025?
• How does the act support innovation for software-based medical devices?
• Are there different enforcement dates for different parts of the regulation?
• How does this new framework compare to regulations in the EU and the US?
• What immediate steps should your company take to prepare for this change?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.