Do you need an FDA Export Certificate?

Medical device companies sometimes call us because one of their overseas customers (or a government agency) has asked them to supply an FDA Export Certificate. In a nutshell, an export certificate is a document prepared by the FDA that contains information about a product's regulatory status in the United States. It is an extra measure of assurance that your product meets US FDA requirements for medical devices sold in the USA. The FDA export certificate helps protect against suppliers who may try to market a product overseas that cannot be sold in the US because it doesn't meet specific US regulations (example: 510k). The FDA has an excellent guide to Export Certificates that we believe will be helpful to you.

To learn more, click here to visit the US FDA website.