Ministry of Food and Drug Safety, World’s First Generative Artificial Intelligence (AI) Medical Device Approval and Review Guidelines Released

News Healthcare & Pharma Guidance

Date: 24th Jan, 2025 Source: Korea Food and Drug Administration (KFDA) Country: South Korea Original Source

Brief

On January 24, 2025, the Korea Food and Drug Administration (KFDA) released the world's first generative artificial intelligence (AI) medical device approval and review guidelines. This guideline aims to help develop and evaluate AI-based medical devices, considering factors such as safety, effectiveness, and regulatory requirements.

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Korea Food and Drug Administration (KFDA)

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Ministry of Food and Drug Safety, World’s First Generative Artificial Intelligence (AI) Medical Device Approval and Review Guidelines Released

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Ministry of Food and Drug Safety, World’s First Generative Artificial Intelligence (AI) Medical Device Approval and Review Guidelines Released

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Korea Food and Drug Administration (KFDA)

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