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Software & SaMD Classification

What is SaMD in Saudi Arabia?​

Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes without being part of a hardware medical device. Under the SFDA framework, SaMD is regulated as a medical device and must be classified and registered via MDMA if it meets the medical device definition.

Classification of SaMD​

The SFDA applies the general classification rules of MDS-REQ 1 to software, informed by IMDRF SaMD classification principles. The classification depends on:

  • The seriousness of the disease or condition the software is intended to diagnose, monitor, or treat
  • The significance of the information provided — whether it is the basis for final clinical decisions or merely informs a clinician
  • The intended user — healthcare professional vs. lay person

Software that directly drives clinical decisions for life-threatening conditions is likely Class C or D; software providing low-risk informational support may be Class A or B.

Software version management in MDMA​

The SFDA requests a clear explanation of the version numbering scheme in the MDMA application for software devices:

  • Which digit/increment represents a major (significant) change — typically triggering re-submission or change notification
  • Which represents a minor (non-significant) change — typically managed through internal change control

Document your software version management policy in the technical file.

AI/ML-enabled devices​

The SFDA is developing its approach to AI and machine learning-enabled medical devices, broadly following IMDRF and international regulatory guidance. Key considerations include:

  • The basis of the algorithm's intended purpose and risk classification
  • Algorithm validation and performance testing
  • Transparency and explainability requirements
  • Predetermined Change Control Plans (PCCPs) for adaptive algorithms

→ AI/ML-Enabled Devices

Further reading​