Companies exporting devices from the US are often asked by foreign customers or foreign governments to supply proof of the devices’ regulatory or marketing status. An export certificate/free sale certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status in the United States (U.S.). UReg will solicit an export certificate from FDA.

UReg will file the request within 3 – 5 business days. It may take up to 1 month for FDA to issue the certificate.

Does not apply