Medical Device Classifications

Understanding the significance
of having products licensed with
Medical Claims from Health Canada

Health Canada uses a Risk Based System

Class 1 Medical Device is the Lowest Risk Rating
Class 4 Medical Device is the Highest Risk Rating

A copy of the quality management system certificate certifying that the quality management system under which the device is manufactured satisfies National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management systems — Requirements for regulatory purposes.

  • Class 1 Medical Device
    • Is licensed to be Safe and Made to Medical Grade
  • Class 2 Medical Device
    • Includes the criteria from Class 1 Medical Device and
    • The Manufacturer has established the evidence for Medical Claims and Therapeutic Benefits
  • Class 3 Medical Device
    • Includes the criteria of Class 1 and Class 2 and
    • Specialized Training must be acquired before the product can be used
    • Example – Laser Therapy or an X-Ray Technician
  • Class 4 Medical Device
    • Includes the criteria of Class 1, Class 2 and Class 3
    • Example – a Pacemaker
    • This is the Highest Risk Based Medical Device
    • The consequences are extremely high to the User, if the product stops working or malfunctions

*Please note that Health Canada is a Regulatory Body that licenses Medical Devices

Health Canada's mandate excludes the promotion of Medical Devices in any form, this responsibility is given to the Manufacturer's and their Representatives.

*This may explain as to "Why", your Medical Doctor may not know about our Medical Devices.*

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