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  • 1.  Labeling assembled products/devices, registration etc.

    Posted 22-Oct-2018 13:43

    Team,

    We are in the process of initiating a new process whereby the idea is that our China based factory (manufacturer) will ship finished products/devices plus accompanying packaging to the shipper in an EU country (let's call it Country XYZ). Shipper XYZ will then pack it to a final packaged product (like holiday sets etc.) and ship to the US. Do we then place on the label:

    Product 'Assembled in Country XYZ', or 'Assembled in EU'? Does it even matter considering that at the time it arrives at the shipper, no further processing takes place except for packaging into sets? Country XYZ is in the EU so technically either would suffice? Is it even mandatory to label it as such? 

    Does "Country XYZ" shipper have to be registered with FDA as repackager/relabeler? 


    Please advise as this is becoming more cumbersome.


    Thank you!


    Laura 



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    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
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  • 2.  RE: Labeling assembled products/devices, registration etc.

    Posted 23-Oct-2018 08:10
    Hello Laura

    So, first for US laws you have to label country of Origin based on total majority of the device' value (components and labor)....your China facility is that since the  final device is there.
    "Made in China". In the US you don't need to list all manufacturing sites on the label, so.I would skip Europe on the label.

    The China facility needs to list and should be compliant to QSR, but  now ISO 13485:2016 too, as FDA heads that way. Your labeler in the EU also needs to list with FDA since packaging/ labeling are  manufacturing activities. They should also be QSR/ISO. And you of course need to be listed.

    Remember to list your UDI if Class 2 and above now for your special things coming in from the EU.


    Good luck, it's a lot to manage.







    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 3.  RE: Labeling assembled products/devices, registration etc.

    Posted 23-Oct-2018 08:34
    ​Hi Laura!

    Remember that all items coming into the US require a country of origin on the label in some fashion.  Stating "Assembled in Country XYZ" is a way to potentially meet the requirement.  Just be certain that you don't get caught up in the language.  I would not use "Assembled in the EU" since this is not a "country" it is a trading bloc and therefore might not meet the requirements of the legislation and could be more easily held at customs on import.

    As for registration - as always - it depends.  If these products are regulated as drugs, biologics or medical devices in the US then you would need your factory to be registered with FDA as a manufacturing plant, the packager in the EU to be registered as a repacker/relabeler and you would need to register as the representative of the product in the US.  If these are cosmetics or cosmetic devices (no medical claims) then you don't need any of these things currently.  Please be advised that there are several bills in Congress currently to potentially change that requirement but none have passed out of Congress as yet.

    ------------------------------
    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 4.  RE: Labeling assembled products/devices, registration etc.

    Posted 23-Oct-2018 11:44
    Ginger & Victor,

    As always, thank you for the feedback.  We are currently compliant with the COO and already place it on the labeling.  The products are both cosmetics and devices.  I thought too that the EU shipper would also need to be listed as a foreign exporter since that is where the final packaged products/devices are coming from into the US.  

    The manufacturer is already compliant and both facilities, the one here, and the manufacturer are already registered with FDA. This is just one of the activities they are adding to one of our facilities in the EU to be able to repackage/relabel those finished products into gift sets.  

    My suggestion is that since they are not QSR/ISO, this activity should be limited to just the cosmetic products.  


    Thank you so much,
    Laura 









    ​

    ------------------------------
    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
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    Original Message


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