Mobile Medical Applications — When MFDS Regulates
When a mobile app IS a medical device
MFDS regulates mobile apps as SaMD when they are intended to:
- Diagnose a medical condition (e.g., AI-assisted ECG interpretation app)
- Treat a medical condition (e.g., app delivering CBT for depression — may be regulated as DTx)
- Monitor a patient's clinical condition for treatment decisions (e.g., continuous glucose monitor companion app)
- Manage a chronic disease through clinical decision support
When a mobile app is NOT a medical device
- General wellness tracking (steps, sleep, calories) without medical claims
- Administrative apps (appointment scheduling, prescription reminders without clinical decision support)
- Simple disease information and education apps
Practical examples
| App | Regulated? | Grade |
|---|---|---|
| AI-powered ECG interpretation (atrial fibrillation detection) | Yes — SaMD | Grade II–III |
| Blood glucose log app (no analysis, just logging) | No | — |
| App that diagnoses diabetic retinopathy from retinal photos | Yes — SaMD | Grade III–IV |
| Step counter with general wellness tips | No | — |
| CBT-based digital therapeutic for insomnia with clinical claims | Yes — potentially DTx | Grade II–III |