License Class Determination and Registration

Get professional help in registering and obtaining In Vitro Diagnostic (IVD) Medical Device License (MDL) from Health Canada as well as get assistance in In Vitro Diagnostic Device 510(k) Registration in US.

Medical Device Regulations

Medical devices have different classes and most classes require licensing. To ensure the device’s safety, quality and efficacy, the Therapeutic Products Directorate (TPD) and more specifically, the Medical Devices Bureau regulates medical devices in Canada.

Medical devices in Canada are classified as per Health Canada’s risk-based practice. There are four device classifications, Class I, Class II, Class III and Class IV. Classification of medical devices dictates the type of license required for your product. 

Health Canada Medical Device Classification

License Class Determination and Registration in Canada

A thermometer is an example of a Class 1 medical device. Class 1 medical devices are excluded from requiring a medical device license. But, for Class 2, 3 and 4 medical devices, a license is mandatory before being allowed to sell devices of these classes in Canada. Class II, III, and IV devices require a product-specific Canadian Medical Device License (MDL). 

Review Time in Different Medical Device Classes

Review time of each Medical Device Class varies. 

Class 2

Class 2 medical devices have a 15 calendar day review time target.

Class 3

Class 3 medical devices have a 75 calendar day review time target.

Class 4

Class 4 has a 90 calendar day review time target respectively.

Fee Charged by Health Canada for Class 2 and 4 Medical Devices

Health Canada imposes a fee that applies to Class 2 and 4 medical devices. Fee will vary depending on the class and whether the device contains human or animal tissue or if the device is for Vitro diagnostic (class 4). As of April 1, 2017, Health Canada fees start at $397 and increase annually by 2% in line with the rate of inflation. Once the license will be issued, your medical device will be listed on Health Canada’s public website. 

Fee Charged by Health Canada for Class 2 and 4 Medical Devices
Health Canada Medical Device Registration

How We Help with Health Canada Medical Device Registration

We have experience serving thousands of medical device companies entering the Canadian market. We will help you.

  • Confirm your device classification in Canada.
  • Complete and file MDL or MDEL applications on your behalf.
  • Act as your regulatory correspondent with Health Canada for your device registration.
  • Develop, implement and modify your quality management system to meet Canadian requirements.
  • Make sure the actual annual license fee payable to Health Canada.
  • Provide onsite auditing to confirm compliance with Health Canada regulations.

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