Health Canada Licence Application Type

[canreg]

Our company (medical devices) in Canada is a distributor for a medical company based in the UK (XX).

XX is looking to launch their product kit in Canada which includes a number of components. The components are not sold individually, only as part of the Kit
Some of the components are made by XX (Labels indicate XX as the manufacturer). But some of the components are not made by them (labels on the components indicate "Made for XX by XYZ").


If we submit a Medical Device Licence application to Health Canada, can this product be submitted as a "Medical Device Group"??

The overall label of the product will state that it is manufactured by XX. But, my concern is will Health Canada accept the application if the components are not made by or labelled under XX?

 

[DannyK]

Hi canreg,

If you will be selling these items as a product kit and not individually then you can apply for them as a Medical Device Group.
The overall label is what Health Canada is interested in.
Since it is a kit, the registrar or notified body performing the CMDCAS audit will or should be checking if the contents correspond to their bill of materials and that any class II or greater items in the kit are licensed to be sold in Canada.