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?