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:

1. Diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms in human beings or animals.

2. 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,

3. Diagnosing pregnancy in human beings or animals,

4. Caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or

5. 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	The device must acquire MDEL certification. The device required an application for registration with an applicable fee. Administrative review is not required
Class II	Devices must comply with ISO 13485 certification & Quality management systems (QMS) The devices must acquire MDL certification. The device requires an application that includes supporting documents, A declaration of conformity with an applicable fee. Administrative review is required.
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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