All You Need to Know About South Korea’s Digital Medical Products Act (DMPA)
South Korea’s Ministry of Food and Drug Safety (MFDS) passed the Digital Medical Products Act (DMPA) on January 23, 2024, which represents a significant step forward in the regulation of digital health technology. Most provisions of the act will come into effect one (01) year after its publication. The DMPA is intended to protect the safety and efficacy of digital medical products, including digital convergence drugs, medical equipment, and health support devices. It establishes a comprehensive framework for managing, manufacturing, and importing these products. This legislation is crucial for digital health regulation and will significantly benefit the digital health field in South Korea. It also addresses key aspects of digital health in South Korea, ensuring a robust and secure environment for digital health innovations. Key Provisions of the DMPA Licensing and Approval: Manufacturers and importers must obtain permits and clearance from the MFDS. The approval procedure i...