South Korea's Game-Changing 2025 Digital Medical Products Act

Medical Device Global Market Access · Aug 24, 2025 · 3m

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…