Who apostilles an FDA Certificate of Exportability?

The U.S. Department of State’s Office of Authentications in Washington, DC. A Certificate of Exportability is signed by an official of the Food and Drug Administration, a federal agency, and under the Hague Conference’s competent-authority listing for the United States federal-agency documents go to the Department of State. No Secretary of State has jurisdiction over it.

That single sentence is the most expensive thing on this page to get wrong. Companies routinely ship an FDA certificate to the Secretary of State of the state where their manufacturing site sits, because that is where every other corporate document goes. It comes back unprocessed, and in the meantime a registration dossier deadline or a shipment date has passed.

What is a Certificate of Exportability, and when do you need one?

FDA issues a family of export certificates, and they are not interchangeable. The distinction that matters here is marketability in the United States:

• Certificate to Foreign Government (CFG) — for products that can be legally marketed in the U.S. and comply with the Federal Food, Drug, and Cosmetic Act.
• Certificate of Exportability (COE) — issued under section 801(e)(1) or section 802, for products that may not be legally marketed in the U.S. but may legally be exported.

So if you are exporting a device, food product, food additive or infant formula that has no U.S. market clearance, has not been cleared for the indication in question, or was built specifically to a foreign buyer’s spec, the COE is your instrument. FDA’s conditions for a section 801(e)(1) certificate include that the product is manufactured in accordance with the specifications of the foreign purchaser, and devices covered by a COE must be labeled for export. FDA’s authority to issue these certificates at all comes from the Export Reform and Enhancement Act of 1996.

Check FDA’s list of export certificate types before you request anything. An apostille cannot repair a wrong certificate. If the product is U.S.-marketable and you were sent down this path by a foreign registry’s template language, you may actually need to apostille an FDA Certificate to Foreign Government or apostille an FDA Certificate of Free Sale instead.

An apostille certifies the signature, seal and capacity of the official who signed the document. It does not certify the contents. On a Certificate of Exportability, the certificate itself says the product may not be legally marketed in the United States — and the apostille does not soften, qualify or override that statement. If a foreign registry treats an apostille as evidence of U.S. approval, correct them before they build a dossier on it.

Federal or state: which chain does each of your documents belong to?

Most export and tender filings are bundles. A Certificate of Exportability travels alongside a certificate of good standing, articles of incorporation, a corporate resolution, a power of attorney for the local agent, and sometimes a commercial contract or distribution agreement. These do not all go to the same office, and the batch moves at the speed of whichever chain you started last.

Two operational consequences fall out of this table. First, the notarised items in the right-hand group get an apostille on the notary’s signature, not on the truth of what the document says. When a foreign registry later queries a clause in your distribution agreement, pointing at the apostille does not answer the question — and companies lose weeks arguing this point. Second, county clerk certification, which some states require before a Secretary of State will act on a notarised document, applies only to that state chain. A county clerk cannot certify an FDA official’s signature. If someone adds that step to the federal document, you have bought a delay and nothing else. Our page on how federal and state business documents are apostilled differently walks the state chain in detail.

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

FDA export certification is center-specific. Devices are handled by CDRH, foods and food contact substances by CFSAN, drugs by CDER, and each center runs its own request channel, its own application content and its own queue. Start at FDA’s export certificate pages for your product category and follow the instructions there for requesting certificates and submitting any required notifications — do not assume the device process applies to a food product.

Practical points that reliably delay a request:

• Registration and listing. Some certificates require current FDA establishment registration and product listing. Lapsed registration stops the certificate before it starts.
• Product naming. The product name, model and catalogue number on the FDA certificate must match what the importing registry expects to see. Mismatched naming is discovered abroad, after the apostille, which means starting over at FDA.
• Country listing. Export certificates are typically issued referencing a destination. Requesting the certificate for the wrong country means the certificate is useless even though the apostille on it is valid.
• Issuance format. FDA has moved parts of its export certification to electronic issuance. Before you plan the apostille stage, confirm with the issuing center whether you can obtain a paper, signed-and-sealed original, because that affects everything downstream.

We do not publish an FDA issuance turnaround here. It varies by center and by workload, and the numbers floating around on commercial sites are stale. Ask the center when you request, and build the apostille stage on top of whatever date they give you.

Digital signature or wet-ink original?

This is the open question that catches the most exporters, and it has two halves that must be answered separately.

The U.S. side: the Office of Authentications verifies a signature it holds on file. Whether it will act on a downloaded, electronically signed FDA certificate, or requires a physical original bearing a seal, is not something FDA or the Department of State state plainly in one place. Confirm it before you file — we confirm it as part of handling the order.

The destination side: the importing health ministry or registry decides what it will accept in its dossier. Some accept a scanned, apostilled set; many still demand the physical paper with the apostille physically attached; some will not accept an electronically issued certificate at all. Get that answer in writing from the registry or your local agent before you choose the certificate format. Nobody in the United States can answer it for them.

What is the correct sequence, and what breaks if you reverse it?

1. Confirm the destination’s Hague status. Check the country on the HCCH Apostille Convention status table. This determines whether you receive an apostille or an authentication certificate plus consular legalization — and it changes the total timeline by weeks. Recent accessions need particular attention, because the entry-into-force date, not the accession date, governs.
2. Ask the receiving registry what it wants. Certificate type, product naming, recency window, whether a translation is required and whether that translation must itself be certified or apostilled. Doing this after the certificate is issued is how bundles get rebuilt from scratch.
3. Request the Certificate of Exportability from the correct FDA center. Confirm establishment registration is current, name the destination country correctly, and ask about paper versus electronic issuance.
4. Start the state-chain documents in parallel. Order the certificate of good standing and certified copies of corporate filings, and get the resolution and power of attorney notarised now. If you wait for FDA first, the state chain becomes your critical path and you lose the overlap.
5. File the federal batch with form DS-4194. The Request for Authentications Service goes to the Office of Authentications with the documents and the filing fee — a fee that is already covered by our flat price. Group documents by destination country.
6. Add consular legalization only if the destination is outside the Convention. The U.S. authentication certificate goes to that country’s embassy or consulate, which sets its own requirements and schedule.
7. Ship the complete set, apostilles attached. Keep high-resolution scans of every page including the apostille before the originals leave your hands.

Reversing steps one and two is the classic failure. A company requests the certificate, apostilles it, ships it, and then learns the registry wanted a different certificate type, a translation bound into the set, or a document issued within a tighter window than the one that elapsed during processing. Every stage after the error has to be repeated, and the FDA stage is the one you cannot accelerate.

How recent must the certificate be when you submit it?

The Department of State does not publish a general age limit for federal documents presented for apostille. The real constraints sit on either side of it:

• FDA’s own validity. FDA training material states that an export certificate is valid for two years from the date of issue. That is the outer boundary.
• The importing registry’s window. Many national registries impose their own recency rule on export certificates — frequently shorter than two years, and sometimes measured from the apostille date rather than the issue date. There is no universal number, and any page that gives you one is guessing.

The operational rule: apostille promptly after issuance. Every week the certificate sits in a drawer is a week subtracted from whatever window the registry applies, and processing time at both FDA and the Department of State consumes part of it before the dossier is even assembled.

Can you apostille several documents in one submission?

Yes, and you should. One DS-4194 can cover a batch, and the Office of Authentications attaches a separate apostille to each document, with the government fee charged per document. One shipment, one queue position, one tracking number.

What batching changes about your timing:

• The batch finishes when the last document in it clears. If one item has a problem, it can hold the shipment — so if one certificate is genuinely urgent and the others are not, split them.
• Group by destination country. A batch going to a Convention country and one going to a non-Convention country need different outputs, and mixing them confuses the filing.
• Only federal documents belong in the federal batch. State documents go to their respective Secretary of State offices and must be run as separate parallel filings — see the full guide to apostilling court, FDA and USDA documents for how the federal-agency and federal-court chains differ.

What happens for countries outside the Hague Convention?

The same Office of Authentications handles it, but the product is different. For a destination that is not party to the 1961 Convention, the office issues an authentication certificate rather than an apostille, and the document then goes to that country’s U.S. embassy or consulate for legalization. That consular stage is governed by the foreign mission: its own requirements, its own appointment system, its own turnaround. Nothing about the U.S. portion predicts it.

Build this into the plan at the beginning rather than discovering it at the end. For companies working to a tender submission date, the consular leg is usually the single largest block of unknown time in the project.

Common reasons an FDA Certificate of Exportability apostille request is rejected

• Sent to a Secretary of State. The most common and most costly error. A state office has no authority over a federal signature and will return the document.
• The wrong FDA certificate was requested. A Certificate to Foreign Government obtained for a product that is not legally marketable in the United States. The apostille stage cannot fix this; only FDA can.
• A notarised photocopy submitted instead of the FDA-issued certificate. Notarising a copy creates a state notarial act whose signature belongs to the notary, which takes the document off the federal chain entirely and makes the FDA signature irrelevant to the certification.
• County clerk certification added to the federal document. Harmless in intent, but it signals the filer is on the wrong chain and adds a shipping leg for nothing.
• An apostille requested for a non-Convention destination, or an authentication requested for a Convention country. The destination determines the output; naming it incorrectly on the request produces the wrong certificate.
• Incomplete DS-4194 or missing fee. The form requires the destination country and return details; a gap stops the file rather than producing a query.
• Return shipping not arranged. Documents sit at the office waiting for a prepaid return label that was never enclosed.
• Format mismatch. An electronically issued certificate submitted where a sealed original is expected, or the reverse at the destination. Confirm both ends before the certificate is generated.
• Product naming that does not match the registration dossier. Not a U.S. rejection — a foreign one, discovered after everything is apostilled and shipped. This is the expensive version.

Where to file, and what we handle

The Office of Authentications sits at 600 19th Street NW, Washington, DC 20006, with a separate mailing address for postal submissions; its current hours, mailing instructions and submission requirements are published on the Department of State’s Office of Authentications page. Processing times move with workload — check that page for the current statement rather than relying on a figure quoted elsewhere.

We charge $120 per apostille, all-inclusive. The government filing fee is included; there is no per-page add-on and no separate government-fee surcharge. For a company running a bundle, that means one predictable line per document whether it is the FDA certificate, the certificate of good standing or the notarised power of attorney. We also confirm the federal-versus-state routing for each item before anything ships, which is where most of the avoidable cost in these projects actually hides.

Requirements vary by destination and the receiving authority has the final say on what it accepts — which is why the registry conversation belongs at the start of the project, not the end.

If you have the Certificate of Exportability in hand, or you know which FDA center is issuing it, send us the destination country and the full list of documents in the bundle. We will tell you which go to Washington, which go to a Secretary of State, which need notarisation first, and what order to start them in so nothing sits idle.