FDA Certificate to Foreign Government Apostille

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Issuing agency

U.S. Food and Drug Administration

We can obtain it?

No — the manufacturer requests it from FDA

Certification first?

No — the FDA-issued certificate is authenticated as issued

Also known as

CFG, export certificate, Certificate to Foreign Government

An FDA Certificate to Foreign Government confirms that a product regulated by the FDA — commonly a medical device, but also foods, animal products and others depending on the issuing center — meets applicable U.S. requirements and may be legally marketed here. Foreign health authorities require it, authenticated, for product registration and import.

The FDA issues several related certificates, and which one you need depends on your product and your facility's inspection status. That, plus the destination's route, is what this page settles.

What a Certificate to Foreign Government is

The CFG is an FDA export certificate stating that the identified product is legally marketed in the United States and that the manufacturing facility meets applicable requirements. It's issued by the relevant FDA center for the product type, and foreign regulators rely on it when deciding whether to register or admit the product.

Importantly, the FDA generally won't issue a CFG where the manufacturing facility hasn't been inspected for compliance with applicable manufacturing requirements — in that situation a different certificate may apply.

Why it needs authentication abroad

A foreign health ministry cannot verify an FDA certificate independently. Authentication by the U.S. Department of State certifies it as genuine — as an apostille for Hague Convention countries, or as an authentication certificate followed by embassy legalization for non-Hague destinations, which is the case for many pharmaceutical and device markets.

Getting the certificate from the FDA

The exporting manufacturer requests the certificate through the FDA's export-certification system; fees apply and vary by certificate type and product center. We can't request it for you — but once the FDA issues it, we run the authentication and legalization chain end to end.

Which FDA certificate you need

The FDA issues a family of export certificates. The common ones:

If you're unsure which applies, ask before you apply — we see registrations delayed by months because the wrong certificate was obtained first.

Document preparation requirements

• Submit the FDA-issued certificate exactly as issued.
• Do not notarize it — notarizing a federal document invalidates it for authentication.
• Don't laminate, staple across the text, highlight, or annotate it.
• Confirm the certificate type matches what the foreign regulator specified.
• Tell us the destination country up front — it determines the entire route.

The step-by-step process

1. Tell us product and destination

   These decide which certificate applies and whether the route is apostille or full legalization.

2. Request the certificate from FDA

   The manufacturer applies through the FDA's export-certification system.

3. Send it to us & we review

   We verify the certificate is in a form the Department of State will authenticate.

4. Federal authentication in D.C.

   We hand-deliver the certificate to the Office of Authentications with the federal authentication request and fee.

5. Embassy legalization, where required

   For non-Hague destinations we forward the authenticated certificate to that country's embassy or consulate.

6. Certified translation, where required

   Where the regulator requires their official language, we arrange certified translation so the dossier is filing-ready.

Common rejection reasons — and how to avoid them

Common uses

• Medical device registration abroad — market entry filings with a foreign health authority.
• Pharmaceutical product registration — supporting a dossier in an importing country.
• Import licensing and customs clearance — evidencing U.S. regulatory status.
• Government tenders — qualifying products for public health procurement.
• Distributor agreements — proving marketing status to a foreign partner.

Hague vs. non-Hague countries

Pick your destination below, or see all countries we serve.

Official references: FDA — Export Certificates · U.S. Department of State — Authenticate Your Document. Government fees are set by these agencies and are separate from our service fee.