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Software as a Medical Device (SaMD)

Definition​

SaMD is software that meets the medical device definition — intended to diagnose, treat, alleviate, or prevent disease or disability in humans — and functions independently of hardware (not embedded in a physical device).

Decision tree: Is my software a medical device?​

1. Is the software intended to diagnose, treat, alleviate, or prevent disease/disability?
   └─ NO → Not a medical device (may be a general wellness product)
   └─ YES → Continue

2. Is the software the primary means of achieving the intended purpose?
   └─ NO → May be an accessory to a hardware medical device
   └─ YES → SaMD — subject to Medical Devices Act

Not regulated by MFDS​

  • Hospital information systems (HIS) used for patient administration
  • Electronic health records (EHR) without clinical decision support
  • General fitness and wellness apps (step counting, sleep tracking without medical claims)
  • Software used to control non-medical equipment

Classification of SaMD​

See SaMD classification for the MFDS grade assignment framework.