Foreign regulators accept a CFG only after the U.S. Department of State has verified the FDA official’s signature on it. This applies to medical devices, conventional foods, food additives and infant formula. Upload your digital CFG and we’ll return it apostilled or authenticated by FedEx, ready for your registration file or shipment.
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
A Certificate to a Foreign Government is an FDA export certificate. It confirms that the products listed on it can be legally marketed in the United States and that the company exporting them meets the relevant U.S. requirements. Overseas regulators treat it as evidence that the product has already passed a strict regulatory system. That is why it is so often a condition for product registration, import licences and public tenders.
The FDA issues CFGs through different centers depending on the product. Two groups make up most of the CFGs our clients bring to us:
For devices that are cleared, approved or exempt for the U.S. market and made by a registered establishment that has listed them with the FDA. Ministries of health often require it to register a device. Examples include diagnostics, surgical instruments, implants and in-vitro test kits.
For conventional foods, food additives, food contact substances and infant formula that meet U.S. Federal Food, Drug, and Cosmetic Act requirements. Food-safety and customs authorities use it to approve imports.
Exporting dietary supplements or medical foods? Those use a Certificate of Free Sale. Drugs use a Certificate of a Pharmaceutical Product. Products that are not approved for U.S. sale use a Certificate of Exportability.
The FDA signs the CFG, but a foreign authority has no way to check that signature itself. The U.S. Department of State, Office of Authentications confirms it is genuine on behalf of the U.S. government.
If your destination belongs to the Hague Apostille Convention, the State Department attaches an apostille and the CFG is ready to use. If it doesn’t, the State Department issues an authentication certificate, and the destination country’s embassy then legalizes it. Many device and food exports to the Gulf, Asia and Africa follow this second route. Check yours on our countries page.
The FDA charges a fee for each CFG it issues. Getting the apostille stage right the first time avoids paying for a replacement certificate.
Send the certificate exactly as the FDA issued it, along with your destination country.
We check that it is a complete, FDA-signed CFG and that it suits apostille or authentication for your destination.
We submit to the Office of Authentications and follow the request through to issuance. You don’t fill in any government form.
Your apostilled CFG ships on our label or your own FedEx account, to you or straight to your importer abroad.
| Item | Amount | What it covers |
|---|---|---|
| Our service fee | $68 / doc. | Document review, State Department submission, tracking and dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total per CFG | $88 | Standard turnaround: 9 business days |
Need several CFGs for different markets? Each certificate is apostilled separately, and you can track every order and its cost in your account.
Foreign regulators compare your CFG line by line with the rest of your dossier. These are the details that most often cause delays:
Model numbers and product names should match your labels, instructions for use and the registration application abroad.
Check that the legal manufacturer and every listed facility appear exactly as the importing authority expects.
A device CFG relies on your FDA establishment registration and device listing. If either has lapsed, fix it before you request a new certificate.
A CFG covers products sold legally in the U.S. Export-only products need a Certificate of Exportability instead.
Some regulators only accept certificates issued within a recent period. Confirm this with your importer before you order.
Upload the FDA-issued file as it is. Edited, merged or re-scanned versions can be refused at the State Department.
It confirms that the products listed on it may be legally marketed in the United States, based on the information the FDA held when it issued the certificate. Foreign regulators use it as evidence of U.S. regulatory status.
Medical devices legally marketed in the U.S., and conventional foods, food additives, food contact substances and infant formula. Dietary supplements and medical foods use a Certificate of Free Sale. Cosmetics use a Certificate for Cosmetics.
The U.S. Department of State, because the FDA is a federal agency. A state Secretary of State cannot apostille an FDA certificate.
9 business days as standard, for $88 per certificate. That is our $68 service fee plus the $20 State Department fee. Expedited options are available.
Yes. Upload the electronic CFG the FDA sent you. Nothing needs to be mailed to us, and the finished document comes back to you by FedEx.
We get a State Department authentication instead, which the country’s embassy then legalizes. Contact us with the destination and we will confirm what is needed.
For dietary supplements, medical foods and foods for special dietary use.
For devices, foods and other products made for export only.
The WHO-format certificate for registering drugs abroad.
A sanitary attestation for certain food-related exports.
For skincare, makeup and fragrance exports.
Compare every certificate type we apostille.
Upload your FDA Certificate to a Foreign Government today. You’ll have it apostilled and on its way by FedEx in 9 business days, for $88 with the State Department fee included.
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