The enforcement of the Digital Medical Products Act in January has rapidly expanded the entry of AI-based medical devices into the South Korean market. The Ministry of Food and Drug Safety (MFDS) is driving this growth by introducing timely guidelines. The Act was designed to systematize the approval and safety management of advanced digital technologies—including artificial intelligence (AI), robotics, and virtual/augmented reality (VR/AR).
To sustain momentum, MFDS has revised four key guidelines covering:
1.Clinical trial design for AI-applied digital medical devices.
2.Approval and review of digital therapeutics.
3.Devices using virtual or convergent technologies.
4.Medical device software approvals.
Beyond the South Korean policy, the MFDS has strengthened international cooperation. In December 2024, it co-published AI medical device trial guidelines with Singapore. In January 2025, through the International Medical Device Regulators Forum (IMDRF), it introduced the Good Machine Learning Practice (GMLP) framework, setting global standards for data independence, clinical representativeness, and risk monitoring.
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