Class III license: Add new device to the license system

[danir30]

Can someone help to clarify if I can make use of the Faxback form to add new device to a license?

 

[mihzago]

if you're just adding a new part number then Faxback is fine. If you're adding a device with significant modifications, then you have to use the license amendment.
Guidance for the Interpretation of Significant Change of a Medical Device - Canada.ca