Software as a Medical Device (SaMD)
When is software a medical device in Saudi Arabia?
Software qualifies as a medical device under the SFDA framework when it has a medical intended purpose — for example:
- Software that analyses ECG data to detect arrhythmias
- AI algorithms that screen radiological images for pathology
- Mobile apps that calculate insulin dosing for diabetes management
- Software that monitors and alerts for patient deterioration
Software used solely to support device hardware (device operating software with no independent medical function) is generally not a separate medical device.
Classification of SaMD
SaMD is classified using the same general classification rules as physical medical devices (MDS-REQ 1), informed by IMDRF SaMD classification principles. Classification depends on:
- Seriousness of the disease or condition addressed
- Significance of information to clinical decision-making
- Intended user (professional vs. lay)
SaMD with high clinical significance for serious conditions will typically be Class C or D; low-risk informational software may be Class A or B.
MDMA for SaMD
SaMD requires MDMA via TFA like any other medical device. The technical file for software must address:
- Intended purpose and use scenarios
- Software lifecycle documentation (IEC 62304)
- Cybersecurity risk assessment
- Usability engineering (IEC 62366-1)
- Algorithm validation and verification
- Version management plan