How Classification Works
The classification system
Canada uses a risk-based classification system with four classes (Class I to Class IV). A device's class determines:
- Whether a Device Licence is required
- The level of pre-market evidence required
- The depth of Health Canada's review
The classification rules are set out in Schedule 2 of the Medical Devices Regulations (SOR/98-282). IVD devices have separate classification rules.
The 16 classification rules
Schedule 2 contains 16 rules that apply to different device types based on risk factors. The rules consider:
| Factor | Examples |
|---|---|
| Duration of contact | Transient (<60 min), short-term (60 min to 30 days), long-term (>30 days) |
| Invasiveness | Non-invasive, surgically invasive, implantable |
| Anatomical location | Skin, mucous membrane, circulatory system, CNS, heart |
| Active vs. passive | Whether the device relies on a power source |
| Diagnostic vs. therapeutic | What the device does |
| Intended user | Healthcare professional vs. lay user |
When multiple rules apply
When more than one classification rule applies to a device, the device is classified at the highest applicable class. This is a key principle — a device cannot be classified at a lower class simply because a lower-class rule also applies.
The four classes at a glance
| Class | Risk | Licence required? | Review depth |
|---|---|---|---|
| I | Low | No (MDEL only) | None (self-declared) |
| II | Low–moderate | Yes | Summary review |
| III | Moderate–high | Yes | Detailed technical review |
| IV | Highest | Yes | Full review including clinical data |
How to determine the class of your device
- Identify the intended use — what the device does and in what context
- Apply the Schedule 2 classification rules — work through each applicable rule
- Identify the highest applicable class
- Apply IVD rules if applicable — IVDs are classified under separate rules (see IVD Classification Rules)
- Consider whether your device is a special type — e.g., combination product, radiation-emitting device, custom-made
Seeking a classification ruling
If you are uncertain about the classification of your device, you can:
- Request a Pre-Submission Meeting (PSM) with Health Canada to discuss classification informally
- Request a formal classification ruling from the Medical Devices Directorate
Health Canada's classification decisions are binding for the purposes of regulatory submissions.
Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 2