Jordan Certificate of Exportability Legalization

Selling Export-Only U.S. Products in Jordan

Not every product made in America is sold in America. Manufacturers build devices to foreign standards, produce regional versions with different labeling or voltage, and sometimes export products while their U.S. applications are still pending. For these, FDA issues a Certificate of Exportability under sections 801(e) or 802 of the Federal Food, Drug, and Cosmetic Act. When such products are destined for Jordan, the certificate may be requested by JFDA or the importer, legalized by the Embassy of Jordan.

How JFDA reads an exportability certificate

The Jordan Food and Drug Administration typically relies on a product’s approval in its country of origin or in a recognized reference market. A Certificate of Exportability confirms that the product may lawfully leave the U.S., but also shows that it is not marketed there. On its own, it rarely satisfies a registration requirement. It works best alongside evidence that the product is approved and sold in another established market, such as a CE certificate and EU free sale evidence for a medical device.

Building a convincing file

Explain the situation directly. A manufacturer’s letter stating why the product is not sold in the U.S., for example because it is built to European or Middle Eastern standards, or is a regional variant of a cleared product, helps JFDA reviewers. Product names, models and manufacturer details must be identical on the certificate, the foreign approvals, the technical documentation and the labels. Your Jordanian agent can advise whether JFDA will accept the combination for your product class before you invest in legalization.

Customs and tenders

At customs, the legalized certificate can help explain why a U.S.-made consignment carries no FDA marketing authorization. In public tenders, especially in the health sector, include it with the foreign approvals in the bid rather than waiting for evaluators to ask.

Legalization steps

The Certificate of Exportability comes from FDA, a federal agency, so it goes directly to the U.S. Department of State for authentication; no notary or Secretary of State is involved. We then lodge it with the Embassy of Jordan in Washington, D.C., through the Jordanian Foreign Ministry’s online system, with the duplicate copy. The embassy usually finishes in about five working days. A notarized manufacturer’s letter can be legalized in the same order. Jordan does not accept apostilles.