Certificate of Exportability Apostille
A Certificate of Exportability shows that the FDA has reviewed an export of a product that may not be cleared for sale in the United States. Foreign buyers may ask for it to carry an apostille.
What this document is
The FDA issues this certificate for certain medical devices and other products exported under sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic Act. It differs from a Certificate to Foreign Government, which covers products legally marketed in the U.S.
Where it is used
A distributor or notified party in Spain or Portugal may include this certificate in an import file for investigational, unapproved or export-only products.
How to prepare it
- Send the signed certificate with all attachments.
- Confirm the exporter name matches your commercial paperwork.
- Tell us which foreign party requested the apostille.
Check this first
Check that you hold the right certificate type before ordering. If the buyer's request names a Certificate to Foreign Government, a Certificate of Exportability will not satisfy it.
How the apostille is obtained
- We review the issuing agency and what your receiving office requires.
- You send the document, unaltered and without notarization.
- We submit it to the Office of Authentications with Form DS-4194 and the $20 fee.
- The Department issues a paper apostille, and we email you a high-resolution PDF.
A common question
Is this handled by Maryland?
No. The certificate is signed by a federal agency, so the apostille comes from the U.S. Department of State.