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Selling products in Canada, distributor? Private Label?

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Old 14th September 2018, 03:33 PM
katastic2908

 
 
Total Posts: 20
Question Selling products in Canada, distributor? Private Label?

Hello,

The company I work for is not ready to switch over to MDSAP, so we have chosen to forgo our Canadian Licenses since we really haven't sold enough there to justify the additional expense of a MDSAP audit. We have a distributor in Canada that is asking the following:

"As your company is not willing to upgrade its ISO 13485 CMDCAS certification to MDSAP, I am suggesting your company provides the full technical file documents to my company then we can include it in our MDSAP registration so we will be able to get a new MDL (medical device license) for these products from Health Canada under my company brand.

This will require an OEM basis agreement between our companies so the products will be made with my company brand (labeling)."


What are your thoughts? Is this ok to do? What risks should we consider? Anything you can add would be most appreciated. If it is ok to do, if you can provide a link or reference to the canadian document that says that, that would be appreciated as well.

Thank you

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