MDL Manufacture & Distributor question

We are a US company that recently became MDSAP certified for US, Canada, & AU and received our MDL for our class II Dental Imaging Software (PACS).

Couple Questions:
1. Does the Manufacturer have to have an MDEL to distribute and sell their product in Canada?
2. If so, can a US manufacturer get an MDEL to distribute in Canada?
3. Our Dental Imaging Software PACS has two product/brand names but is the exact same product and code base but one is deployed locally the other is cloud-based and deployed on AWS. Can these both use the same MDL or do they require separate MDLs?

Any assistance is much appreciated!

1) No, you only need an MDL. Refer to this guidance - there's a very helpful table that will tell you whether you need an MDEL, MDL, or neither.
2) See above, you would only get the MDEL if you were distributing ONLY class I. Your importer/distributor in country would have an MDEL.
3) You can have multiple products under the same license. If they are exactly the same I think Health Canada would not have an issue with it. Sometimes they will ask to split up devices onto different licenses, but it's not a big deal and it's easy to do in the course of the review if they request it.
See the guidance here under Item 8 on the MDL type: Guidance on how to complete the application for a new medical device licence: Guidance for implementation - Canada.ca

EmiliaBedelia's answers are correct.
Just to add: The only time a manufacturer would require an MDEL if they were selling class I medical devices. Since your device is class II , this situation does not apply.
If you are using distributors to sell the medical device in Canada, please ensure that they have an MDEL.

DannyK said:

EmiliaBedelia's answers are correct.
Just to add: The only time a manufacturer would require an MDEL if they were selling class I medical devices. Since your device is class II , this situation does not apply.
If you are using distributors to sell the medical device in Canada, please ensure that they have an MDEL.

Click to expand...

So even though we have an MDL for our Class II we would also need an MDEL to market another Class I device?