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License Class Determination and Registration

As in most developed countries, medical devices have different classes and most classes require licensing.   The Therapeutic Products Directorate (TPD) and, more specifically, the Medical Devices Bureau regulates medical devices in Canada ensuring their quality, safety and efficacy.  

Class 1 are exempt from requiring a medical device license.  An example of a class 1 medical device is a thermometer.  Class 2, 3 and 4 medical devices require a medical device license before being allowed to be sold in Canada.  

Class 2 medical devices have a 15 calendar day review time target whereas class 3 medical devices have a 75 day and class 4 have a 90 day review time target respectively.

A fee by Health Canada applies to class 2 to 4 medical devices.  This will vary based on the class and whether the device contains human or animal tissue or if the device is an for vitro diagnostic (class 4).  As of April 1, 2017 the Health Canada fees start at $397 and increase annually by 2% in line with the rate of inflation.

After license is issued, the medical device is listed on Health Canada’s public website which can be found here.