Selling products in Canada, distributor? Private Label?


Starting to get Involved

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
Hello katastic,

Our company sells medical devices on a OEM/Private Label basis globally and there is nothing generally wrong with entering into these agreements provided you protect yourselves. However, my reading of the information regarding Health Canada's transition to MDSAP is that your distributor cannot qualify for MDSAP (hence, must cease to sell your product - stockpiling not allowed) without your cooperation as it is the manufacturer who gets the certificate, not the distributor.

Please see Q7: Notice: Medical Device Single Audit Program (MDSAP) Transition Plan - Frequently Asked Questions (FAQ) -

Please excuse my unsolicited inquiry and advice but why is your company "not ready" to proceed with MDSAP? We certainly were not ready, either and it took me many months of convincing to get everyone on board with MDSAP. In the end, the process was pricey but not that arduous. If costs are the problem, then maybe your distributor, upon finding out they must discontinue your device if you don't qualify for MDSAP, will be willing to provide some support - perhaps in exchange for credits down the road or some other low cash-impact methods of financing.

Edward Reesor

Involved In Discussions
As a Canadian manufacturer of medical devices with MDSAP certification, I have considered doing something similar, i.e. taking a non-MDSAP certified product and incorporating it as one of our products as a private labeled device. This allows access to the Canadian market without the actual manufacturer having to undergo the MDSAP program itself (another discussion on this forum discusses how the mandatory MDSAP program by Health Canada is driving foreign products from our markets).

What I am reading is that they already have MDSAP certification and are willing to add it to their Health Canada licenses as a private labeled device of their own. In order to do that, they will need all the technical files that go along with licensing a medical device as if it was their own. I would suggest a NDA agreement in order to solidify and protect your IP. There may be added costs associated with them getting it licensed, however those may be offset by your cost savings by withdrawing from Canadian CMDCAS registratrion. You may have to consider a price adjustment for their work and involvement in getting it back on the market.

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