SaMD and AI/ML Notification
MFDS has issued dedicated guidance (κ°μ΄λλΌμΈ) and notifications on SaMD and AI/ML-based medical devices.
Key documentsβ
- 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 IMDRFβ
MFDS SaMD guidance is aligned with IMDRF N10 (definitions), N12 (risk categorization), and N23 (clinical evaluation) documents.
Related pagesβ
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.