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
Standalone vs. embedded software
SaMD regulations apply to software that operates independently or on general-purpose computing platforms. Software that is integral to a hardware medical device (i.e., cannot function separately from the hardware) is typically regulated as part of the hardware device rather than as standalone SaMD. When determining regulatory pathway, consider whether the software can be used independently of any hardware component.