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Medical Device Misclassified by Health Canada

noanalyst

Starting to get Involved
#1
About two years ago we contacted Health Canada for help with classifying our simple ENT device. At the time we were told it was a class II device. Two years later, we are about to launch, and just realized per the rule based classification that it is actually a class I device. I contacted Health Canada but they have refused to budge. It is so obvious their mistake, their refusal to change their classification appears intentional.

Can someone tell me where we should go from here.....should I seek legal representation? Is there an appeal process?

Any help would be appreciated.
 
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