Canada Medical Device Regulations

Agency
All medical devices are regulated by Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau.
Medical Device Definition
A device means an instrument, apparatus, contrivance or other 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 (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals, (b) 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, (c) diagnosing pregnancy in human beings or animals, (d) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or (e) 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 (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal. Food and Drugs Act
Classification of Medical Device
International ClassificationExamplesRisk Level
IChemistry analyzerLow
IIUrine test stripsLow - Moderate
IIIBlood Glucose self-testingHigh - Moderate
IVHIV blood analyzerHigh
Premarket Approval Process
IIIIIIIV
Class I devices may skip these stepsEnsure quality management system (QMS) is implemented (ISO 13485)
Health canada must audit ISO
Apply for medical device establishment licenceApply for medical device licence (MDL).
Submit application and pay fee.Submit application including declaration of conformity (DoC) and QMS (ISO). Pay application fee.Submit application including DoC, ISO, and clinical data. Pay application fee.
Class I devices do not undergo this review process.Health Canada will review application.Health Canada will review application. Device will also undergo premarket review.
If approved, Health Canada will issue registration.
Additional Information
ValidityOne year
Postmarket Surveillance Must have surveillance systems in place
TimelineClass I and II: approximately 2 months. Class III and IV: approximately 4-8 months.
LanguageAll documents may be submitted in English or French
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