FDA export certificates: product, shipment and eligibility

Start with the document and shipment route

Ask the importer or destination authority which document is required, who may issue it and whether it needs authentication. Identify the product, manufacturing country, shipment origin and destination. An FDA-issued export certificate is different from a food registration record, MoCRA submission or private provider certificate. A shipment into the United States does not automatically require an FDA export certificate; assess the applicable import requirements and requested document instead.

Choose the correct food certificate

For eligible products exported from the United States, the Certificate to a Foreign Government (CFG) covers conventional foods, food additives, food contact substances and infant formula that meet applicable U.S. marketing requirements. The Certificate of Exportability (COE) concerns products meeting the statutory export conditions; it does not establish permission for U.S. sale. The Certificate of Free Sale (COFS) is available only for dietary supplements, medical foods and foods for special dietary use. Ordinary foods have no universal FDA product-listing requirement.

Separate device CFG and CFG-NE

A standard medical-device CFG concerns eligible devices exported from the United States. Certain devices manufactured outside the U.S. and shipped to another foreign country may qualify for CFG-NE. Check current establishment registration, device listing, U.S. marketing status, import or offer for import into the U.S., applicable manufacturing compliance and the stated enforcement-action conditions. Foreign-to-foreign shipment alone is insufficient. The relevant certification authority is section 801(e)(4) of the FD&C Act.

Check cosmetic certificate restrictions

FDA does not issue cosmetic export certificates for cosmetics manufactured outside the United States or for raw or bulk materials. Its cosmetic document is titled CERTIFICATE, with product-specific or general options; FDA does not call it a cosmetic Certificate of Free Sale. Eligibility concerns products intended solely as cosmetics. Destination acceptance must be checked. A MoCRA facility registration or product listing is a separate action, not an FDA export certificate or product approval.

Read the attestation and verify authenticity

The meaning of an FDA certificate depends on its type and the information available when issued, including applicant attestations where applicable. It is not universal independent testing or a guarantee of full compliance, and issuance does not prevent later FDA action. Certificate authentication, marketing authorization, registration status and acceptance by the destination are separate checks. Use the appropriate FDA verification route; do not assume an old portal remains current.

Prepare a specific document enquiry

Prepare the requested document name, product and intended use, manufacturer and manufacturing country, shipment origin and destination, relevant existing records, and the authority's written request. Identify which programme applies before applying. Drug, biological and animal-product certificates follow their own issuing-centre rules. Check current application requirements, government fees and processing separately; there is no single registration prerequisite, fee or timeline for all certificates. Do not share account usernames or passwords.

Confirm professional scope before proceeding

For a clear next step, contact FDABridge with the product, manufacturing country, shipment route and buyer’s document request. Discuss the relevant existing registration services and request a written scope and professional quote, with government charges identified separately. This helps you choose suitable support before payment. Certificate issuance and destination acceptance follow the applicable programme and country requirements.

FDA: https://www.fda.gov/food/exporting-food-products-united-states/food-export-certificates

FDA: https://www.fda.gov/medical-devices/exporting-medical-devices/devices-not-exported-united-states

FDA: https://www.fda.gov/medical-devices/exporting-medical-devices/types-export-certificates

FDA: https://www.fda.gov/cosmetics/cosmetics-exporters/cosmetics-export-certificate-faqs

FDA: https://www.fda.gov/food/food-export-certificates/export-certification-faqs

Discuss your document and service needs: https://fdabridge.com/contact