Skip to main content

SaMD and AI/ML Notification

MFDS has issued dedicated guidance (가이드라인) and notifications on SaMD and AI/ML-based medical devices.

Key documents​

  • SaMD Classification Guideline — criteria for determining when software is a medical device and its grade
  • AI/ML Medical Device Guideline — algorithm validation, post-market monitoring, and PCCP concept
  • Digital Health Framework — 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.

Post-market requirements

AI/ML devices require ongoing performance monitoring and retraining protocols. MFDS mandates submission of performance data at specified intervals (typically annually for high-risk algorithms) and triggers for algorithm retraining or update notifications to users.