FDA Export Certificates: When Foreign Manufacturers Need Them and How to Obtain Them

Many foreign governments require that US-regulated products — food, drugs, medical devices, and cosmetics — be accompanied by a certificate from the FDA confirming their compliance with US regulations before allowing importation. These certificates are sometimes called a 'Certificate of Free Sale,' a 'Certificate for Foreign Government,' or a 'Certificate to Foreign Government.' The terminology varies by product category and destination country. Understanding what these documents are, what they confirm, and how to obtain them is an important part of exporting US-regulated products to markets that require FDA documentation.

What FDA export certificates confirm

An FDA export certificate does not approve the product for sale. It is a document issued by the FDA that confirms specific facts about the product and the manufacturing facility — typically that the facility is registered with the FDA, that the product is lawfully marketed in the United States or would be if intended for US sale, and that the product is manufactured in compliance with applicable US regulations. The certificate provides a foreign importing authority with independently verified information about the product's regulatory status in the United States. It is a statement of fact, not an endorsement or product approval, and its value to foreign regulators depends on what the specific destination country requires.

Types of FDA export certificates

For food products, the FDA issues a Certificate for Foreign Government (CFG) that confirms the facility's registration status and that the product meets applicable US food safety requirements. For medical devices, the FDA issues a Certificate to Foreign Government (CFG) under 21 CFR 801.58 that confirms the device is legally marketed or exempt from premarket review in the United States. For biological products, drug products, and other FDA-regulated categories, different certificate types apply. Not every FDA-regulated product is eligible for every type of certificate — a facility must have current, valid FDA registration and must be in good regulatory standing to obtain a certificate.

When foreign manufacturers need them

Foreign manufacturers who export US-regulated products to countries that require FDA documentation as a condition of market entry need export certificates. This is common for food products exported to countries in Southeast Asia, the Middle East, and Latin America, where health authority import procedures require FDA registration certificates. Medical device manufacturers who export devices to emerging markets where US FDA approval is used as a proxy for product quality and safety regularly need device export certificates. The requirement is driven entirely by the destination country's import regulations, not by the FDA's own requirements for products leaving the United States.

Facility registration as a prerequisite

An FDA export certificate cannot be obtained for a facility that is not currently registered with the FDA, or for a product that is not properly listed in the FDA's registration databases. This is why a foreign manufacturer who has not yet completed FDA registration — and who discovers mid-transaction that a foreign buyer requires an FDA certificate — is forced to complete the registration before the certificate can be requested. The FDA does not issue export certificates for unregistered facilities or unlisted products. Current, accurate registration is the prerequisite for obtaining the documentation that many export markets require.

How FDABridge assists with export certificates

FDABridge manages FDA food facility registration and product listing for foreign manufacturers, which are the prerequisites for obtaining FDA export certificates. We assist clients in identifying which certificate type is required by the destination country and in making the appropriate FDA certificate request. Visit fdabridge.com/food to learn about our services or fdabridge.com/apply/food to begin the registration process.