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Country Of Origin

  • 1.  Country Of Origin

    Posted 14-Oct-2014 09:19
    I understand there is no requirement for EU to add country of origin or 'Made in _____' on the labeling, but is there such a requirement for other countries? I thought most countries need that information at least on the shipper label in order to import the medical device (or IVD). I understand Australia does not require the country of origin. I'm looking for at least one country that does require.
    Any advice would be appreciated.
    Thanks in advance,

    Steven Goldberg RAC, MBA, PMP
    Regulatory Affairs Manager
    Nova Biomedical
    Waltham, MA
    United States

  • 2.  RE: Country Of Origin

    Posted 15-Oct-2014 05:31

    Russia requests "made in XXXX" on product labels
    Ondina Maria Iovicin - Grigorescu

  • 3.  RE: Country Of Origin

    Posted 16-Oct-2014 04:39

    Not required for EU nor Australia as far as I am aware.

    Sandra Nicoll
    European Veterinary Regulatory & Technical Services Manager
    Abbott - ENTERPRISE
    Maidenhead, Berkshire
    United Kingdom

  • 4.  RE: Country Of Origin

    Posted 16-Oct-2014 09:53
    COO is generally a Fair Trade regulatory requirement, not explicit in medical device regulatory requirements.

    Certainly a requirement in industries such as toys to electronics to textiles and household goods. Since it is the basis of so many other activities, I advocate marking COO on packaging of all devices for international trade. 

    I do know that in those other industries in the US, if a device is made in the US, you do not need to include COO (Made in the USA) It is not required.

    If you are looking for regulations, look in commerce rules.

    Thomas Heckmann
    Regulatory Manager
    Reichert Inc
    Depew NY
    United States

  • 5.  RE: Country Of Origin

    Posted 16-Oct-2014 10:20
    My experience is the same as what Thomas described. Look in the country's import/export regulations. They will give you labeling and documentation requirments for COO and other special requirements in order to import/export products. I have run into COO requirments for most countries when exporting an IVD product from the US. I have even had product thrown away in Singapore customs as it did not have the correct documentaion. Stephanie ------------------------------------------- Stephanie Gaulding Principal Consultant CAI Consulting Centreville VA United States -------------------------------------------

  • 6.  RE: Country Of Origin

    Posted 17-Oct-2014 11:53
    US customs regulations require COO marking for all devices made outside and to be imported into U.S. Please refer to 19 CFR 134.11.

    Jintao Chen PhD
    Director, Regulatory Affairs
    Roche Molecular Systems
    Pleasanton CA
    United States

  • 7.  RE: Country Of Origin

    Posted 16-Oct-2014 11:45
    Thank you both,

    To add to this question, when determining country of origin, what are the deciding factors?  Is the definition of country of origin standardized across various commercial fields (i.e. Textile, Medical, Electronics, etc.)?  



    Thomas Ostrowski
    Regulatory Affairs Specialist
    Draeger Medical Systems Inc.
    Andover MA
    United States

  • 8.  RE: Country Of Origin

    Posted 17-Oct-2014 11:31
    Hi Thomas,
    This question gets tricky as the CoO determination can be influenced both by where you are manufacturing and where you are shipping.  The USA has very specific requirements around claiming Made in the USA on your label (see FTC restrictions), as does Switzerland.  The USA also has very specific requirements around determining the country of origin when all activities are not in one location, or all components do not come from a single location.  This leads to what is referred to as determining the point of substantial transformation, which can be influenced by previous legal determinations.  Other countries may determine CoO based upon value of individual components or operations, or upon the entity that takes responsibility for the release of the product. 

    If your product is manufactured and sourced from a single location, then it should be straightforward. Please reply to me directly if you have further questions.

    Carole Harris RAC
    International Regulatory Consultant
    Asuragen, Inc
    Austin TX
    United States

  • 9.  RE: Country Of Origin

    Posted 16-Oct-2014 16:30
    I haven't worked with Saudi Arabia the last couple of years but as far as I remember they also require COO marking for medical devices.

    Patricia Taige
    Director Quality Assurance & Regulatory Affairs
    Seno Medical Instruments Inc.
    San Antonio TX
    United States

  • 10.  RE: Country Of Origin

    Posted 16-Oct-2014 15:45

    Hi Steven

    In Brazil ANVISA recognizes the concept of legal manufacturer. So, it is not necessary to include MADE IN statement under RA point of view.
    However, the customs requires the origin information for taxes purposes. As the origin is not always clear in the registrations, it is highly recommended to include this information on the labels.

    Let me know if you have any comment,



  • 11.  RE: Country Of Origin

    Posted 17-Oct-2014 12:45
    We need to look at the applicable requirements from different angles (e.g., Customs and Health Authority/FDA labeling requirements per se).

    As for import purposes and in the US, as an example, COO is regulated under the Tariff Act of 1930 (Chapter 4 of USC, Title 19; that is, 19 USC 4).

    You may download the applicable Act in PDF at

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