Regulatory Open Forum

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  • 1.  Country of Origin

    Posted 04-Dec-2015 10:01


    Is there anyone out there who can provide a list of markets requiring "Country of Origin" on device labels?

    Best regards,

    Ajrulla Zuta

    Ajrulla Zuta RAC
    Senior Regulatory Affairs Consultant
    Mediteq AB

  • 2.  RE: Country of Origin

    Posted 05-Dec-2015 07:54

    Hi.. Usually, the Country of Origin (COO) requirement is a trade compliance requirement for import tax purposes. So it is required for all countries.

    Hope this helps.



    Sattu Sreenu Babu
    Manager-Regulatory Affairs (APAC & Middle East)
    Cardinal Health

  • 3.  RE: Country of Origin

    Posted 07-Dec-2015 03:29

    Hi Arjulla,

    Please find a link to country of origin labeling requirements on U.S. imports here:

    Please be aware that in addition to this information, certain products, such as pharmaceuticals, are subject to additional labeling requirements.

    Kind regards,

    Paul Kooijmans
    Regulatory Affairs manager
    The Netherlands

  • 4.  RE: Country of Origin

    This message was posted by a user wishing to remain anonymous
    Posted 18-Apr-2019 13:57
    This message was posted by a user wishing to remain anonymous

    Dear all, 

    what factors do determine the Country of Origin (CoO) ?

    If my device is designed in France, but all implementation work is conducted in India, which country would I need to list as CoO? 

    Is the determination based on accountibility (France), based on the amount of resoucres (India>France) or other factors?



  • 5.  RE: Country of Origin

    Posted 18-Apr-2019 16:04
    Typically the question (at least in the US and I think this is more generally applicable to the global landscape as well but not as certain of that) is where is the "final practical transformation" performed.  So it doesn't matter where the product is designed nor does it necessarily matter where it is tested/released.  It matters where it is finally put together into the final working device.  So in your case the first check would be where is the product manufactured?

    Some countries have specific requirements for "Made in" claims especially when they are claiming to be made in the country itself.  So for the US, not only does the final practical transformation have to occur in the US but also mostly all inputs must qualify as US made or US derived before a product can claim to be "Made in USA" as a marketing term.​

    Victor Mencarelli
    Director Regulatory Affairs
    United States

  • 6.  RE: Country of Origin

    Posted 19-Apr-2019 12:18
    In addition to COO, there is an additional issue if stating "Made in the USA." This is a claim and has legal implications. Check with counsel.

    Corey Jaseph RAC
    Director of Regulatory Affairs
    South Jordan UT
    United States

  • 7.  RE: Country of Origin

    Posted 22-Apr-2019 19:13
    Hi everyone, in my knowledge CoO is a trade certification for getting among others, exception import taxes rates, but depends on what are the involved countries (exporting-importing), international trades agreements, etc. but it is based on where the most of the inputs including labor are coming from.
    Best regards,

    Maria Fuentes
    RA Sr Manager