USE MDSAP of an other canadian company

LAM2020

Starting to get Involved
Hello we are a manufacturer of medical device class IIa based in Europe. We are looking into selling our products in Canada. We do not have MDSAP certification but we have ISO 13485 certification. I heard that we can go through a company based in CANADA that ALREADY has MDSAP and they can submit our documentation to health canada ; they will become the manufacturer of the device. Is this way possible? Thanks
 

DannyK

Trusted Information Resource
Hi LAM2020,
In order to get on the Canadian market, you can contact a company that has MDSAP and this could shorten the time and reduce the costs.
It does not necessarily need to be a Canadian company.
I have helped many companies get their Canadian licenses.
It is important to find the right fit.
What is your device that you want to distribute in Canada?

Danny
 

LAM2020

Starting to get Involved
Hello, this is a class IIa medical device certified under to the MDR with class I accessories. My understanding is that the company will become the manufacturer in Canada, but is it possible for us to still remain on the label please ;) no necesseraly as the manufacturer but we want to appear on the label thanks
 

DannyK

Trusted Information Resource
The classification in Europe is different than in Canada.
The name on the label has to correspond to the name on the Health Canada license.
 

Emma2010

Involved In Discussions
Hello, this is a class IIa medical device certified under to the MDR with class I accessories. My understanding is that the company will become the manufacturer in Canada, but is it possible for us to still remain on the label please ;) no necesseraly as the manufacturer but we want to appear on the label thanks
Hi LAM2020, did you figure out the problem? We are dealing with the same issue and wondering how to add our company name to the labelling too. Can you share your thoughts?
Thanks a bunch!
Emma
 
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