Korean MFDS Announces Guidelines for Generative AI-Based Medical Devices

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The Ministry of Food and Drug Safety (MFDS) announced on January 24, 2025, the publication of the world’s first "Approval and Review Guidelines for Generative AI-Based Medical Devices". These guidelines are designed to support the safety and efficacy evaluation of medical devices utilizing generative artificial intelligence (AI) technology.

For more details, please check the News section on the GCA KOREA website!


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