Hello All,
our device is currently registered in Argentina as a Class III. Our Distributor is saying that they are not allowed to export broken medical devices so that we as the Manufacturer can repair them (in the USA) and then re-import the device into Argentina. If anyone is familiar with the regulations in Argentina, could you please confirm whether this is true or not or any alternative routes we could pursue?
thank you!
------------------------------
Rebecca Tucek
Melbourne FL
United States
------------------------------