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GTIN (Global Trade Item Number) for non CE Mark

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#1
Hello,

We are attempting to move some production to a new supplier for USA shipment only. Our current product is manufactured and has CE approval and marking on the device. The new device will be USA only, lower cost and no CE marking. I know we need a new SKU for this item but does it need a new GTIN for USA only?
 

kreid

Involved In Discussions
#3
This is a question I have been thinking about recently. One of my clients has asked a similar question wrt country specific labels, in their case the same device but with different language labels.
Their issuing agency is GS1 and in their spec. it says that producing a new label (with different language) triggers a new GTIN.
But I fail to understand the logic of this.
I would have thought the point of a GTIN was that it is Global, so if I have a problem with a device that means I need to do a recall, surely it would be better/simpler/more efficient to have one GTIN to recall regardless of what type of label I have on the device?
I would be interested to other views/experience and knowledge on this.
Thanks
K
 
#5
GTINs are not just intended for your customers, but for the wider supply chain; imagine a wholesaler stocking a complete range of products, they don't look at the name, or the language, they look at the GTIN. If the GTIN is not changed between langauge variants, they could ship the items to the wrong country.

@kreid,
A product with different langauges cannot be traded uniformly and must be identifiable in the supply chain; UDI will assist in recall but it is not the be all and end all; take hip joints with multiple sizes - they should all have different GTINs and REFs - but what if the hip system is recalled? you have to look at all applicable GTINs

If you want to have a standard reference regardless of language variant and are using GS1, I suggest using AI - (240)
 
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