Health Canada submission

[navdeep]

Hi everyone,
Can someone please provide me some information about pre submission to Health Canada? I am looking to get feedback regarding device classification. Additionally I can't find any other predicate device listed in HC database that could be used as predicate for an exoskeleton, is there any feedback for the same?
Thanks
Navdeep

 

[DanMann]

In terms of a pre-submission, I found Health Canada very approachable and I just emailed their medical devices address and they came back with some really useful advice. Not sure about predicate devices for an exoskeleton, but it's worth being aware that Canadian approval mechanisms are not like the 510(k) system in the US - each device is assessed on its own merit (although it can use data from similar or equivalent devices).

 

[navdeep]

Thank you so much DanMann