The regulatory landscape for medical devices in South Korea continues to evolve, with recent updates introducing a more flexible and structured approach to managing product changes. In March 2026, the Ministry of Food and Drug Safety proposed revisions to the Enforcement Rule of the Medical Devices Act, aiming to streamline how manufacturers handle post-approval changes to medical devices. This development reflects South Korea’s broader effort to enhance regulatory efficienc

South Korea has taken another major step toward shaping the future of digital health regulation. In late November 2025, the Ministry of Food and Drug Safety (MFDS) released an updated guidance document providing clearer, more structured expectations for the development, approval, and lifecycle management of AI-enabled and software-based medical devices. As artificial intelligence continues to transform diagnostics, treatment planning, and patient monitoring, regulatory autho

On 29 April 2024, the Philippines FDA added Korea’s Ministry of Food and Drug Safety (MFDS) as its new Reference Drug Regulatory...

On 25 March 2019, South Korea's Ministry of Food and Drug Safety (MFDS) published a notification titled "Professional revision of medical...

Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...

Korea MFDS' entry into the International Medical Device Regulators Forum (IMDRF), together with their intention to harmonize with the...