Canada Medical Device Regulations
Regulatory Agency
Health Canada is responsible for regulating medical devices in Canada.
Medical Device Definition
Medical Device: An instrument, apparatus, contrivance, or another similar article, or an in vitro reagent, including a component, part, or accessory of any of them, that is manufactured, sold, or represented for use in:
- Diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms in human beings or animals.
- Restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,
- Diagnosing pregnancy in human beings or animals,
- Caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
- Preventing conception in human beings or animals:
however it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs 1. to 5. solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal: (instrument).
Medical Device Classification System
| International Classification | Risk Level | Examples |
|---|---|---|
| Class I | Low risk | Elastic bandages, Tongue depressors, Hand-held manual toothbrushes, Hot water bottles, Disposable razors |
| Class II | Low-Moderate risk | Blood glucose meters, Powered wheelchairs, Pregnancy test kits, Powered surgical instruments, Powered air-purifying respirators |
| Class III | High-Moderate risk | Implantable pacemakers, Surgical mesh, Intraocular lenses, Silicone breast implants, Implantable cardioverter defibrillators |
| Class IV | High risk | Radiation therapy machines, Implantable heart, Defibrillators, Implantable ventricular assist devices, CT scanners MRI machines |
Regulatory Approval Process
Classification |
Approval procedure |
|---|---|
Class I |
|
Class II
Class III
Class IV |
|
Notes : – After approval, registration will be granted. |
|
Additional Information
Approval timeline |
Class I: 4 to 5 months, Class II: 1 to 2 months, Class III: 4 to 5 months, Class IV: 6 to 8 months |
License validity period |
1 year |
Fees |
Class II : $615, Class III : $13,559, Class IV : $29,405 |
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