Yamini,
Yes, you can definitely sell the same product under different names and labeling in different markets. It happens all the time. The trick is to think through HOW you do this. For instance, many companies create different part numbers for each product, and link all the testings, DHF and regulatory approvals to them appropriately in their QMS. Then think about how you will control this - do you have a process for ensuring the part numbers/products don't get shipped into the wrong market, do you place "for export only" labeling on the EU product etc, etc. Just work through the QS requirements and make sure you document how each is addressed. It can be super helpful to put together a Quality Plan to document how you have done so.
I have seen it done without differing part numbers, but not recently. I suspect the customer confusion of trying to sort out both sets of required information in the labeling is getting harder and harder to validate. I could see though, a process for "just in time" final labeling maybe working - I just would not recommend it.
Yes, the FDA will look at both products should they come in and inspect. Remember that for US based manufacturers, they have jurisdiction over "export only" products too. However, I have not ever had a problem with this, as they tend to focus on products you market in the US unless you are doing something egregiously wrong and they want to see how widespread it might be.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 17-Oct-2019 12:15
From: Yamini Nidumolu
Subject: 510k IVD product to CE mark
Hello All,
At my company we are working to commercialize an approved class II IVD product into EU. So, our AR( Authorized Representative) will our sister company in EU. They want the product components in different names and codes rather than how it is approved in US to make the product user friendly and minimize errors at customer site.
My question is,Can we have the same product with different names in our Quality system? Is this advisable to do? or better to stick with the same product names and codes as it is approved by FDA.
- Is the change at all needed?
- Will FDA raise questions later when they audit us?
- Will it be a very bad impact on this decision if taken?
Thank you and need advice in this matter.
Yamini
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Yamini Nidumolu
Bellevue WA
United States
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