South Korea

Understand MFDS clinical trial requirements for digital medical devices, including real-world evidence, data-based studies, and software validation expectations.

Supporting foreign manufacturers entering South Korea with regulatory services for medical devices, IVDs, and quasi-drugs.

Learn about Cisema’s redesigned website with faster performance, clearer navigation and expanded Asia Pacific coverage.

Summary of 2025 MFDS trends covering medical device approvals, import dynamics, and the shift toward AI and software-based regulation.