Does an FDA CFG go to the Secretary of State or the U.S. Department of State?

An FDA Certificate to Foreign Government is a federal document signed by a U.S. Food and Drug Administration official, so only the U.S. Department of State’s Office of Authentications can apostille it. No state Secretary of State has authority over a federal signature. The request is filed on form DS-4194 and must name the destination country.

That single fork is where most export filings go wrong. A Secretary of State maintains specimen signatures for the officials commissioned in that state — notaries, county clerks, the vital records registrar, the corporations division. An FDA official is not on that list. Send the CFG to Sacramento, Albany or Tallahassee and it comes back unprocessed, having burned a week or two of a registry deadline that was already tight. The same logic is covered in more depth in our guide to which business documents are federal and which are state.

What is an FDA Certificate to Foreign Government, and who asks for it?

A Certificate to Foreign Government (CFG) is an FDA export certificate confirming that a product meets U.S. requirements and may be legally marketed in the United States. Importing health ministries and drug registries ask for it before they will let a product in. In practice you will be asked for one when you are:

• Registering a drug, biologic or medical device with a foreign regulatory authority;
• Bidding on a public tender run by a ministry of health, where the CFG is part of the mandatory dossier;
• Clearing a shipment through customs in a market that ties import permits to the exporting country’s regulatory status;
• Appointing a local distributor or in-country authorised representative who must file your regulatory file on your behalf.

The CFG almost never travels alone. A typical registration dossier also carries a certificate of good standing for the exporting entity, articles of incorporation, a corporate resolution authorising the local agent, a power of attorney, and sometimes the distribution commercial contract — and each of those takes a different route to an apostille. Our walkthrough of an FDA CFG for a medical device going to Turkey shows how the bundle moves in practice.

How do you get the certificate from FDA in the first place?

You cannot apostille a certificate you do not yet hold, and the FDA stage is normally the longest part of the project. FDA issues export certificates through the center that regulates your product — drugs, biologics and devices are handled by different centers with different request systems and different supporting information. Eligibility generally turns on the product being legally marketable in the United States and on your establishment registration and product listing being current and free of outstanding compliance issues.

Because FDA’s request routes, forms and certificate formats are revised periodically, confirm the current request channel and the supporting information required on FDA’s export certificate pages at fda.gov for your specific product center before you build a timeline. Three things are worth nailing down at that point, because they all affect the apostille stage:

• How many original certificates you can request at once. If three registries each demand an apostilled original, you need three originals from FDA. You cannot photocopy your way out of it.
• Whether the certificate is issued on paper with a wet signature and seal, or electronically. This decides whether an apostille can be physically attached.
• Exactly how the destination country is named on the certificate. A registry will reject a certificate that names a different country than the one filing it.

Which of your export documents are federal, and which are state?

Build the dossier as two parallel tracks from day one. Federal documents go to Washington; state-issued and notarised documents go to the Secretary of State of the state that produced them.

Certified copy versus notarised copy — and where the county clerk fits

A certified copy is produced by the office that holds the record and carries that office’s own seal. A notarised copy is a photocopy with a notary’s statement attached, and the only signature an apostille can then certify is the notary’s. Apply that to a federal certificate and you have converted a federal document into a state document about a photocopy — which is why a notarised CFG copy gets you a state apostille that the foreign registry will not accept.

County clerk certification belongs to the state track only. A minority of states require the county clerk to certify the notary’s commission before the Secretary of State will act. It is never part of the federal route: there is no county step between FDA and the Department of State. If someone tells you to take the CFG to a county clerk, that instruction came from a state-document checklist. Our guide to apostilling a power of attorney and other notarised documents covers where the clerk step actually applies.

An apostille certifies the signature and seal on a document — not the truth of its contents. On a notarised corporate resolution or contract, it confirms only that the notary’s commission is genuine. When a foreign registry queries the substance of an agreement, an apostille is not the answer, and adding a second one will not help.

How do you apostille the CFG, step by step?

1. Confirm the registry’s requirements first. Ask the importing authority, in writing, whether it wants an apostille or a consular legalization, how recent the certificate must be at filing, and whether a certified translation must be attached before or after authentication. Everything downstream depends on these answers.
2. Request the CFG from FDA. Apply through the center that regulates your product and order every original you will need — one per registry, plus a spare. Check the product names, establishment details and destination country on the certificate the day it arrives.
3. Start the state-track documents in parallel. Order the certificate of good standing and certified copies of your articles of incorporation, and get the resolution, power of attorney and any contract notarised. These go to a Secretary of State, not to Washington, and can run at the same time as the FDA request.
4. File DS-4194 with the Office of Authentications. Complete form DS-4194, naming the country of use, and submit it with the FDA original and the government fee — which is included in our flat price. Current submission instructions are on the Department of State’s authentication services page.
5. Receive the apostille. The certificate comes back with the Department of State’s certificate affixed by ribbon and seal. Do not detach, staple through or unbind it — a broken attachment is treated as a tampered document.
6. Add the consular step if the destination is not a Convention member. The Department of State issues an authentication certificate instead, and the document then goes to that country’s embassy or consulate in the United States for legalization.

Reverse any of these and you pay for it. Notarise before you check the federal/state fork and you have authenticated the wrong signature. Apostille before you ask the registry about translations and you may have to re-translate and re-authenticate the whole set. Order one FDA original for three registries and the fourth market waits for a fresh FDA request. See how the U.S. Department of State apostille process works for the mechanics of the federal filing itself.

Does the registry accept a digitally signed CFG, or does it want wet ink?

Treat this as two separate questions with two separate answers. First, whether the U.S. authentication authority will attach an apostille to an electronically issued certificate — an apostille is physically affixed to paper, so the format FDA gives you matters. Second, whether the importing registry accepts anything other than an original bearing an original seal; many national drug and device registries still insist on wet ink and reject printed PDFs outright, even apostilled ones.

Confirm both before you commit. If either side says no, you need a paper original from FDA, and that resets your timeline to the FDA issuance stage.

How recent must the certificate be when it is submitted?

No U.S. authority applies a general expiry date to a CFG. The recency rule is imposed by the importing registry, and it varies by country and sometimes by product class. What matters operationally is which date the registry counts from — some measure from the FDA issue date, some from the apostille date, and the difference can be the whole shipping and processing window.

Ask the registry which date governs, then work backwards. If a certificate must be recent on arrival, ordering the CFG early and letting it sit while you assemble the corporate documents is the wrong sequence: start the state-track documents first and request the CFG so it arrives close to the point of filing.

Can several documents be apostilled in one submission?

Yes — a single request can cover a batch, and each document receives its own apostille certificate and is feed separately. Batching saves shipping and handling, not review time per document. The real constraint is jurisdictional: federal documents and state documents cannot be bundled into one filing. Your CFG goes to the Department of State while your good-standing certificate and notarised power of attorney go to one or more Secretaries of State, and if your entity documents come from two states, that is two state filings.

Check the Department of State’s current submission instructions for any limit on the number of documents per request and per day before you send a large batch, since walk-in and mail channels have differed in the past. Our overview of apostilling court, FDA and USDA documents covers mixed federal batches in more detail.

What if the destination country is not in the Hague Convention?

Then there is no apostille. The Department of State issues an authentication certificate, and the document is legalized afterwards by the destination country’s embassy or consulate in the United States — each of which sets its own requirements, forms and appointment rules. Several large pharmaceutical and device markets still sit outside the Convention.

Before you assume either way, check the HCCH status table for the Apostille Convention. Two details catch exporters out: a state may have acceded but the Convention may not yet have entered into force between it and the United States, and another contracting state may have objected to an accession, which keeps the legalization chain in place between those two countries.

Common reasons an apostille request is rejected

• Sent to a Secretary of State. The most expensive error in this workflow. A state office cannot authenticate an FDA signature and will return the certificate.
• No country of use on DS-4194. The form requires you to name the destination country; without it the request is not processed.
• Apostille requested for a non-Convention country. The correct output is an authentication certificate plus consular legalization. Asking for the wrong instrument delays the file.
• A photocopy or a notarised copy instead of the FDA original. The federal route authenticates the FDA signature on the document FDA issued.
• A signature not on file. If the signing official’s specimen signature is not held by the Office of Authentications, the document cannot be authenticated until that is resolved.
• Payment defects. Wrong payee, wrong instrument, or a fee that does not match the number of documents. When we file for you this is handled inside the flat price.
• Damaged or re-stapled attachments. Removing or re-fixing a ribbon and seal invalidates the certificate at the receiving end.
• A certificate that aged out in transit. The registry’s window expired while the document sat in the authentication queue or in a courier bag.
• Mismatched entity names. The company name on the CFG, the good-standing certificate and the power of attorney must match the name on the registration file, character for character.
• Translation attached at the wrong stage. Some registries require the translation to be authenticated too; binding it in after the apostille means re-doing the filing.

Requirements differ by country and by registry, and the receiving authority always has the final say on what it will accept.

What to do next

Get three answers in writing from the importing registry — apostille or legalization, recency window and which date it runs from, and translation requirements — then request your FDA originals and start the state-track corporate documents at the same time. When the CFG arrives, the federal filing is a DS-4194 submission to the Office of Authentications naming the destination country.

If you would rather hand the filing off while you work on the registration dossier, we file federal apostilles at $120 per apostille, all-inclusive: no separate government-fee surcharge and no per-page add-ons. Start an order with your document details and the destination country, and we will tell you up front whether your document belongs on the federal track, the state track, or both.