Medical device licences
35,876 active and 38,281 archived licences in Health Canada’s Medical Devices Active Licence Listing. Devices of Class II, III and IV need a licence before they are sold in Canada; most Class I devices, the lowest-risk group, do not.
By risk class
| Risk class | Count |
|---|---|
| Class I (lowest risk; most Class I devices need no licence) | 250 active |
| Class II (low to moderate risk) | 55,48726,441 active |
| Class III (moderate to high risk) | 15,3787,851 active |
| Class IV (highest risk) | 3,2671,584 active |