Ask Robert Packard.

Rob Packard Thank you for the shout out Joe. I wrote a blog on it 3 years ago. The blog can be found at http://medicaldeviceacademy.com/health-canada-vs-european-class-rules/. The answer is most likely Class III in Canada, but there are occasional differences. The best thing to do is write your classification rationale and then email it to the device licensing group in Canada.

EU Class IIa can also be CAN Class 3

I would start with Mohammad Kondri, He works in LA for the Canadian Government Mohammad.Kondri@international.gc.ca. He surely would know the right people to connect you with.

Dr Ali A.Mohamedi Thanks for the valuable inputs and awaiting to hear more from you..

Classification in Canada vs EU: Rules are similar but not identical. If you could email me a bit of information on the device at my below address, I could give you a quick opinion.
Nancy J Ruth, Director, Medical Devices
Mapi SRS

Dr Ali A.Mohamedi Dear Nancy Ruth (CanReg), Please advise your email so that I can furnish you with further details. Regards,Ali

Grace Fu Palma This is not surprising. Countries do not follow US FDA. We focus on China FDA. FDA exempt could be CFDA class II. Registration is an art at the same time. Where your product fit also has to do what you claim etc.

No worries. The main add-on from a complete US/EU registration is the "Essential principles checklist", which is highly similar to the "Essential requirements checklist". Australia has a similar additional requirement.