What is NOT a Medical Device?
Understanding what falls outside the scope of medical device regulation is just as important as knowing what falls within it. Misclassifying a product as a non-device can expose a company to significant compliance risk.
Products regulated under other frameworks
The following are not regulated as medical devices in Canada, but are regulated under separate frameworks:
| Product | Regulated as | Framework |
|---|---|---|
| Pharmaceuticals | Drug | Food and Drugs Act — drug provisions |
| Biologics (vaccines, blood products) | Biologic | Food and Drugs Act — biologic provisions |
| Natural health products (vitamins, herbal remedies) | Natural health product | Natural Health Products Regulations |
| Cosmetics | Cosmetic | Food and Drugs Act — cosmetic provisions |
| Pesticides | Pest control product | Pest Control Products Act |
| Food | Food | Food and Drugs Act — food provisions |
General wellness and consumer products
Products marketed purely for general wellness purposes — with no medical claims — are generally not regulated as medical devices. Examples:
- General fitness trackers marketed only for wellness (step counting, calorie tracking with no clinical claims)
- Lifestyle apps with no diagnostic or treatment claims
- Sunglasses (no medical claim)
- Non-corrective contact lens solution for non-prescription lenses (no medical claim)
A product that starts as a wellness product may become a medical device if the manufacturer adds medical claims. Once a medical claim is made — even in advertising — Health Canada may regulate the product as a device.
Radiation emitting devices
Some devices that emit radiation are regulated under the Radiation Emitting Devices Act (REDA) rather than (or in addition to) the Medical Devices Regulations. See Radiation Emitting Devices Act.
Borderline products
Health Canada acknowledges that the line between medical devices and other product categories is not always clear. For borderline products, Health Canada can provide a classification ruling to help manufacturers determine whether a product is regulated as a medical device.
Common borderline areas:
- Software: only software with a medical intended use is a medical device — see Is Your Software a Medical Device?
- Drug-device combinations: the primary mode of action determines regulatory category — see Combination Products
- Aesthetic devices: devices used for non-medical aesthetic purposes (e.g. cosmetic lasers) may or may not be regulated as medical devices depending on their claims and risks
Key principle
If there is any doubt about whether a product is a medical device, the safest approach is to contact Health Canada's Medical Devices Directorate for a classification ruling before proceeding with commercialisation.