Licensing and regulatory approval
Does your innovation:
- Diagnose, treat, mitigate or prevent disease, disorder or abnormal physical state, or any of their symptoms
- Restore, modify, or correct, body structure, or the functioning of any part of the body
- Have software involved in the manipulation, analysis, editing of data, generation of images, determination of measurements, identification of a region of interest in an image or identification (through alarm or alert) of results from a monitor that are outside of an established range
Note: Consider how the device will be marketed or advertised. Making specific health claims (e.g. for a specific medical condition) may trigger a medical device classification.
If you have further questions about licensing and regulatory approval, contact Health Canada.
Health Canada medical device classification
If you answered "Yes" above, then your device likely qualifies as a medical device. This figure can be used to determine the risk classification of the device.
Given that you answered "Yes" to the above question, your device will be Class 1, unless it meets the criteria of a higher class, as outlined in the figure below.
