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SaMD and AI/ML Notification

MFDS has issued dedicated guidance (κ°€μ΄λ“œλΌμΈ) and notifications on SaMD and AI/ML-based medical devices.

Key documents​

  • SaMD Classification Guideline β€” criteria for determining when software is a medical device and its grade
  • AI/ML Medical Device Guideline β€” algorithm validation, post-market monitoring, and PCCP concept
  • Digital Health Framework β€” overarching policy document for digital health product regulation

Alignment with IMDRF​

MFDS SaMD guidance is aligned with IMDRF N10 (definitions), N12 (risk categorization), and N23 (clinical evaluation) documents.