Software & SaMD Classification
Is your software a medical device?
Software is a medical device if it meets the definition in the Food and Drugs Act — i.e., it is used for the diagnosis, treatment, monitoring, or prevention of a disease or condition in human beings. Specifically, Software as a Medical Device (SaMD) is software that:
- Has a medical intended use
- Achieves that purpose without being part of a hardware medical device
See Software as a Medical Device (SaMD) for the full definition and examples.
IMDRF SaMD classification framework
Health Canada follows the IMDRF SaMD classification framework, which considers two dimensions:
Dimension 1 — State of healthcare situation
- Critical — the condition is immediately life-threatening or could result in irreversible injury
- Serious — the condition could result in significant clinical intervention or significant patient management change
- Non-serious — the condition is not immediately life-threatening and does not require significant clinical intervention
Dimension 2 — Significance of information to healthcare decision
- Treat or diagnose — drives/triggers immediate clinical action
- Drive clinical management — aids a clinician or patient in making a treatment or management decision
- Inform clinical management — informs clinical management without direct treatment or diagnosis impact
Resulting IMDRF categories and HC class mapping
| IMDRF Category | Description | Typical HC Class |
|---|---|---|
| Category I (lowest) | Inform clinical management in non-serious situations | Class I or II |
| Category II | Drive clinical management in non-serious, or inform in serious situations | Class II |
| Category III | Drive clinical management in serious situations | Class II or III |
| Category IV (highest) | Treat/diagnose in critical situations | Class III or IV |
Examples by class
| Software | Class |
|---|---|
| General wellness app with no clinical claims | Not a medical device |
| Medication reminder app (no dosing logic) | Class I |
| Spirometry analysis software | Class II |
| Dermatology AI screening tool | Class II or III |
| Radiation therapy planning software | Class III |
| AI diagnostic tool for life-threatening conditions | Class IV |
Software updates and classification
When software is updated, manufacturers must consider whether the update changes the device's classification or requires a Device Licence amendment. See Amending a Device Licence.
Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 2; IMDRF SaMD Classification guidance N12FINAL:2014