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Product Branding Change

Discussion in 'Other Medical Device Regulations World-Wide' started by Vintage Goose, Apr 8, 2016.

  1. Vintage Goose

    Vintage Goose Active Member

    Oct 6, 2015
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    Hi, a few years ago, the company I work for purchased another company in a different EU country. Until now there has been no move to integrate the product ranges (general IVDs sold worldwide). Now it is being suggested that we re-brand the second company's products with our branding, but retain the original company name, address, CE Marking, etc.

    Primarily, this means changing the carton colour from yellow to white and a change in logo on the carton, label and IFU. However, CE Marking and Declarations of Conformity are unchanged, as are technical specifications, intended use, instructions etc.

    I expected this to be straight forward and most countries are not seeing any issue with this. However our distributors in S America (Peru, Ecuador, Venezuela) say they need to re-register the products at a significant cost. With 50+ products, they say the cost will run into 10s of thousands of dollars.

    Does anyone have any experience in these areas they can help me with? Would you expect to re-register products at a significant cost for such a minor change?
  2. indicator

    indicator Member

    Sep 7, 2017
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    If there is a change in following criteria, then you need to re-register the device.
    • Manufacturer name changes
    • Sponsor name changes
    • Class of device changes
    • GMDN code changes
    • Intended purpose changes