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.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 18-Apr-2019 11:41
From: Anonymous Member
Subject: Country of Origin
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?
Thanks!
Original Message:
Sent: 07-Dec-2015 03:29
From: Paul Kooijmans
Subject: Country of Origin
Hi Arjulla,
Please find a link to country of origin labeling requirements on U.S. imports here:
http://www.cbp.gov/trade/rulings/informed-compliance-publications/terminology-and-methods-marking-country-origin-us-imports
Please be aware that in addition to this information, certain products, such as pharmaceuticals, are subject to additional labeling requirements.
Kind regards,
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Paul Kooijmans
Regulatory Affairs manager
The Netherlands
Original Message:
Sent: 12-04-2015 10:00
From: Ajrulla Zuta
Subject: Country of Origin
Hello,
Is there anyone out there who can provide a list of markets requiring "Country of Origin" on device labels?
Best regards,
Ajrulla Zuta
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Ajrulla Zuta RAC
Senior Regulatory Affairs Consultant
Mediteq AB
Jonsered
Sweden
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