SaMD and AI/ML Guidance
Key MFDS guidance documents
| Document | Content |
|---|---|
| SaMD Classification Guideline | When software is a medical device; grade classification criteria |
| AI/ML Medical Device Guideline | Validation requirements, algorithm transparency, PCCP concept |
| Digital Health Framework | Overarching policy for digital health regulation |
| Cybersecurity Guidance | Requirements for connected devices (in development) |
IMDRF alignment
MFDS SaMD guidance aligns with:
- IMDRF N10 — SaMD: Key Definitions
- IMDRF N12 — SaMD: Possible Framework for Risk Categorization
- IMDRF N23 — SaMD: Clinical Evaluation