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  • 1.  Different GTIN for different importers or distributors?

    This message was posted by a user wishing to remain anonymous
    Posted 16-May-2024 16:13
    This message was posted by a user wishing to remain anonymous

    Does anyone know of any country that requires a different GTIN for identical devices that are imported or distributed by different entities?

    E.g., I have two different importers/distributors for a medical device. The medical device shipped to either importers is identical.

    Does anyone know of a reason why I might want to have a different GTIN for different importers/distributors?



  • 2.  RE: Different GTIN for different importers or distributors?

    Posted 17-May-2024 02:04

    Hello Anon,

    I am not aware of a country who requires a different GTIN, though UDI regulations are being implemented in other countries quite often and there are still bit of interpretation in countries which do have UDI requirements.  The GTIN is the combination of the company prefix assigned and the Device Identifier, so it is unique to the company and model/version of the finished device.  The reason a GTIN would be different (mostly the Device Identifier would be different) is the physical packaging and look of the product is different.  Because remember for Unique Device Identification (UDI) it needs to be always viewed from the user's perspective.  If there are two products which are identical, though have different packaging configurations, this may need two different UDI, because the user would/could view as two different products.  In your example, if the product is identical, including the packaging and packaging configuration, I am not aware of a requirement where two GTIN/UDI would be needed for a different distributors.  If the product would be identical, this should not have an impact if sent to two different distributors since the product is the same.  Though again there might be some odd or required import requirements for a country if importing to two different entities - even having different addresses on the label might be considered "different" - but I am not aware of anything such as that.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 3.  RE: Different GTIN for different importers or distributors?

    Posted 17-May-2024 02:36

    Hello,

    as Richard is mentioning, there are indeed several European countries with adapted UDI regulations, although I am not aware that there would be any request to have different GTINs, when the distributor is different, this at least if the device remains identical !

    Important is indeed that also the package is part of the product, so different package could (would) be a different GTIN



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    Franky Dubois
    QA/RA Manager
    FEops
    Gent
    Belgium
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  • 4.  RE: Different GTIN for different importers or distributors?

    Posted 17-May-2024 09:09

    The UDI-DI (GTIN for GS1) is an attribute of the device (version or model) and not the distribution channel.

    If you have different UDI-DIs for each distribution channel, then you will need different part numbers for the devices since they will have different labels. This will ensure the device is in the correct distribution channel. This is not an efficient inventory management practice.

    I don't know of any regulatory regions that requires it nor can I think of any good reason why you want to do it.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 5.  RE: Different GTIN for different importers or distributors?

    Posted 17-May-2024 14:34

    Hello

    I tend to agree with avoiding mix up using GTIN/versioning, in case the packaging bears  different information eg related to each specific distributor/importer, especially if there isn't a destination labeling option.



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    Rekha Roveri
    RA Director
    Switzerland
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  • 6.  RE: Different GTIN for different importers or distributors?

    This message was posted by a user wishing to remain anonymous
    Posted 20-May-2024 09:06
    This message was posted by a user wishing to remain anonymous

    Thanks for the insight, all! One of our distributors had requested this, and it seemed odd to me. If the packaging doesn't change, I will push back on them.