Software and SaMD Classification
Software as a Medical Device (SaMD) is software that meets the medical device definition and functions independently of hardware.
When is software a medical device?
Software is regulated when intended to diagnose, treat, alleviate, or prevent disease or disability in humans. Pure administrative or general wellness software is not regulated.
MFDS SaMD classification framework
Risk grade determined by two factors:
- Significance of information provided (critical → serious → non-serious)
- Healthcare situation (critical → serious → non-serious)
| SaMD type | Typical grade |
|---|---|
| Diagnostic AI for CT scans in treatment-critical condition | III–IV |
| ECG analysis for non-critical condition | II–III |
| Clinical decision support (diagnosis suggestions) | II–III |
| General wellness app | Not regulated |
AI/ML devices
Follow the same SaMD classification logic with additional requirements for algorithm transparency and post-market monitoring. See AI/ML-based medical devices.
Relevant legislation
- Medical Devices Act, Article 2
- MFDS Notification — Classification criteria for software medical devices