Your product is made in the United States but not sold here. A Certificate of Exportability (COE) is the FDA’s confirmation that it can still be exported legally. When your foreign buyer or regulator needs that certificate legalized, upload it and we’ll have it apostilled or authenticated by the U.S. Department of State, then ship it by FedEx.
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Some U.S. manufacturers make products only for foreign markets. These may be built to an overseas customer’s specifications, or authorized abroad but not by the FDA. Because these products can’t be marketed in the U.S., they don’t qualify for a Certificate to a Foreign Government. Instead, the FDA issues a Certificate of Exportability. It confirms that the product meets the U.S. legal conditions for export, even though it isn’t sold domestically.
The FDA issues COEs for medical devices and for food products. For devices there are two versions, named after the section of the Federal Food, Drug, and Cosmetic Act they rely on:
For Class I and Class II devices that aren’t authorized for the U.S. market and are made for export only. It also covers some devices with a 510(k) still under review, if they are similar to a device that is already cleared.
For unapproved Class III devices and certain Class II devices, including investigational devices. These have stricter conditions. One is usually a valid marketing authorization from a “Tier 1” country: Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, or an EU/EEA country.
For foods, food additives and similar products that can’t be legally marketed in the U.S. but meet the export requirements of section 801(e) of the Act.
Every Certificate of Exportability rests on the same four conditions from section 801(e)(1). The exporter confirms them in a signed statement to the FDA. False statements are a federal offence, so check that each one is true before you apply.
A COE 802 adds further requirements. These include substantial conformance with the FDA’s quality system rules or a recognized international standard, and that the device is not adulterated or misbranded apart from lacking U.S. authorization.
Applying for the wrong certificate is one of the most common reasons an export file gets delayed. This comparison shows which one fits your product:
| Certificate of Exportability | Certificate to a Foreign Government | |
|---|---|---|
| U.S. market status | Not authorized for sale in the U.S. | Legally marketed in the U.S. |
| Typical products | Export-only devices, investigational devices, foods made to foreign specifications | Cleared or approved devices, conventional foods, infant formula |
| Legal basis | FD&C Act sections 801(e)(1) or 802 | U.S. marketing authorization and compliance |
| What it tells the regulator | The product may be legally exported from the U.S. | The product may be legally sold in the U.S. |
| Apostille process | Identical: U.S. Department of State apostille or authentication, $88 per document through us | |
The U.S. Department of State attaches an apostille that confirms the FDA signature. The COE is then ready to file in any member country.
The State Department authenticates the certificate, and the destination country’s embassy completes the legalization.
See which applies on our countries page.
The FDA issues the Certificate of Exportability after approving your application.
Send us the certificate exactly as issued, together with the destination country.
We check it, submit it to the Office of Authentications and follow it to issuance.
Your apostilled COE ships to you, your buyer or your agent abroad.
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $68 / doc. | Review, submission, tracking and dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total per COE | $88 | Standard processing: 9 business days. The FDA’s certificate fee is separate. |
A CFG is for products legally marketed in the U.S. A Certificate of Exportability is for products that aren’t authorized for U.S. sale but meet the legal conditions for export.
A COE 801 covers export-only Class I and Class II devices under section 801(e)(1). A COE 802 covers unapproved Class III devices, certain Class II devices and investigational devices. It has additional quality, labeling and, usually, Tier 1 country authorization requirements.
Yes, under section 802. One example is export for clinical investigation in a Tier 1 country. Our service starts once the FDA has issued the certificate.
The U.S. Department of State, because it’s issued by the FDA, a federal agency. A state Secretary of State cannot apostille it.
$88 per certificate, which is our $68 service fee plus the $20 State Department fee. Standard processing takes 9 business days, and expedited options are available.
Yes. Upload the certificate as the FDA issued it. Nothing needs to be mailed to us, and the apostilled document comes back by FedEx.
For devices and foods legally marketed in the U.S.
The WHO-format certificate for registering human drugs.
For dietary supplements and medical foods.
A sanitary attestation for certain food-related exports.
For skincare, makeup and fragrance.
Compare every certificate type side by side.
Upload your COE today and receive it apostilled by FedEx in 9 business days. $88 per certificate, State Department fee included.
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