License Amendments and Renewals - Canadian Regulations vs. US vs. EU

E

endlesslovehv

#1
Do you see the Canadian regulations as having the worst elements of both the U.S. and EU?

In what areas is the Canadian model similar to the U.S., and in which areas is it similar to the EU?
 
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R

Roland Cooke

#2
Actually I would argue the reverse, even if the execution is uneven, and there are plenty of oddities scattered throughout.


Health Canada mandates ISO13485, the certificate must be issued by a Registrar that HC has individually approved, and all audits must include an auditor that HC has individually approved.

By and large that means that companies holding SCC certs are subject to robust audits on an ongoing basis.

So that is different from the US model, and similar (but not identical) to the EU model.


Health Canada keeps the technical and regulatory approval of high-risk (both clinically and politically) devices in-house.
So that is similar (but not identical) to the US model, and different from the EU model.


There are some negatives to the system as well of course, but overall I think it is a fairly effective approach.
 
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