Do you need an Initial Importer ?
Are you a foreign manufacturer of medical devices ?
If the answer is yes, you need to pay attention at the FDA regulations about exportation to the US market.
If you don’t have a physical presence in the US and if that establishment in the US is not registered with the FDA, you need to make sure your buyer in the US is registered as Initial Importer to the FDA.
The best option is to work with a third party who could be your Initial Importer umbrella for the entire US market.
But don’t worry, we can help !