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FDA Certificate of Exportability Legalization | AACC

FDA Certificate of Exportability Legalization for Arab Countries

Some U.S. products are made for export only and aren’t sold in the United States, often because they’re built to a foreign buyer’s specification. For these, the FDA issues a Certificate of Exportability instead of a certificate of free sale. The Arab American Chamber of Commerce legalizes it by the federal route and helps you check whether the Arab regulator will accept it.

A federal certificate: it starts at the U.S. Department of State. The Certificate of Exportability is signed by the FDA, so it isn’t notarized and doesn’t go to any Secretary of State. Saudi Arabia, Morocco, Bahrain and Algeria accept the Department of State apostille. The other Arab countries also need embassy legalization.

The document

What a Certificate of Exportability Is

A Certificate of Exportability confirms that a product which may not be sold in the U.S. can still be legally exported, because it meets the U.S. export requirements and the importing country’s specifications. It is different from a CFG, which confirms U.S. free sale. Because it doesn’t confirm free sale, some Arab regulators accept it only in specific cases.

Export-only devices

Medical devices made to a foreign specification or not cleared for the U.S. market.

Devices

Export-only drugs

Unapproved drugs exported under FDA export provisions.

Drugs

Check acceptance first

Some regulators want proof of U.S. free sale (a CFG or COPP) instead.

Ask first

Not a free sale certificate

If your product is sold in the U.S., request a CFG or COPP.

See CFG
Start here

Choose the Destination Country

Choose the destination country to start your order.

Country
U.S. steps
Final step
U.S. stepsOriginal → U.S. Department of State apostille
Final stepApostille (since July 9, 2026)
U.S. stepsOriginal → U.S. Department of State apostille
Final stepApostille
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEgyptian Embassy or consulate
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Iraq
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Jordan
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Kuwait
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Lebanon
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Libya
U.S. stepsOriginal → U.S. Department of State apostille
Final stepApostille
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Oman (business documents since 2021)
U.S. stepsOriginal → U.S. Department of State authentication
Final stepPalestinian legalization arranged by our team
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Qatar
U.S. stepsOriginal → U.S. Department of State apostille
Final stepApostille (since December 2022)
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Sudan
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Syria
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Tunisia
U.S. stepsOriginal → U.S. Department of State
Final stepUAE Embassy (through VFS Global), then MOFA in the UAE
U.S. stepsOriginal → U.S. Department of State authentication
Final stepEmbassy of Yemen

Embassy fees for FDA certificates vary by country. We confirm the amount with your order.

The legalization process

How a Certificate of Exportability Is Legalized

  1. Confirm the regulator accepts itAsk your agent whether the authority accepts an exportability certificate or needs a free sale certificate (CFG or COPP).
  2. Obtain it from the FDARequest the certificate with the products and importing country stated exactly as in your file.
  3. Authentication in WashingtonWe take the original to the U.S. Department of State. For Saudi Arabia, Morocco, Bahrain and Algeria, its apostille is all you need.
  4. Embassy stepFor embassy countries, the embassy legalizes the authenticated certificate. For the UAE, it goes through VFS Global, then MOFA.
  5. Returned to youSent with tracking, ready for the import or registration file.

Common mistakes: notarizing the certificate, sending it to a Secretary of State, or using an exportability certificate where the regulator requires proof of U.S. free sale. Confirm what the regulator accepts before you apply.

Before you send

Required Documents

What to send us

  • The original certificate from the FDA, exactly as issued.
  • The regulator’s request, if you have it, so we can confirm the document matches.
  • Your online order for the destination country, paid online or through Pay Invoice.
  • Return label: a prepaid FedEx/UPS waybill or a tracked USPS Priority Mail envelope, or buy one at checkout.

Ask your agent before applying

  • Does the authority accept an exportability certificate?
  • Is a CFG or COPP required instead?
  • Do the product names need to match the import permit?
  • Is a recent issue date required?
Often legalized together

Related Export Certificates

Certificate to Foreign Government (CFG)

The free sale certificate for products sold in the U.S.

Federal route

Certificate of Pharmaceutical Product (COPP)

The certificate for drugs.

Federal route

Certificate of Free Sale

A comparison of federal and state free sale certificates.

By issuer

Technical Data Sheet

Specifications that often go with the certificate.

Notarized
Processing time

Processing Time and Fees

Apostille countries

Saudi Arabia, Morocco, Bahrain, AlgeriaU.S. Department of State apostille
Notary or Secretary of StateNot needed
Embassy stepNone

Embassy countries

U.S. Department of StateAuthentication
Embassy feeBy country
TimeCall us for your country

Processing time runs from receipt of the FDA original. You’ll see our service fee and the shipping cost at checkout, with no notary or state charges.

Why AACC

Why Choose the Arab American Chamber of Commerce?

Correct federal routeWe never send FDA documents to a notary or state office.
Acceptance checkedWe help you confirm the regulator accepts it before you spend time and fees.
One order for the fileCertificates, letters and data sheets, legalized together.
Mailing

Where to Send Your Certificate

Maryland office (fastest)

Arab Chamber of Commerce
1615 Bay Head Rd., Annapolis, MD 21409
(410) 349-1212

Washington, D.C. headquarters

1330 New Hampshire Ave. NW, B1, Washington, DC
(202) 347-5800
Monday to Friday, 8:00 am to 6:00 pm ET

FAQ

Certificate of Exportability Legalization: Common Questions

Does a Certificate of Exportability need a notary?

No. It is an FDA document. It goes straight to the U.S. Department of State, and notarizing it can lead to rejection.

What is the difference between a Certificate of Exportability and a CFG?

A CFG confirms the product can be sold in the U.S. A Certificate of Exportability covers products that may only be exported. Regulators often treat them differently.

Which Arab countries accept an apostille on it?

The apostille is accepted in Saudi Arabia, Morocco, Bahrain and Algeria. For any other Arab destination, including Oman and the UAE, the certificate goes on to embassy legalization, assuming the regulator accepts this type of certificate at all.

Will an Arab regulator accept it?

It depends on the authority and the product. Many want proof of U.S. free sale. Check with your agent before you apply.

How long does legalization take?

The apostille route is the shortest. Embassy countries add the embassy’s processing time. Call us for a current estimate.

Exporting a product not sold in the U.S.?

Tell us the product and destination. We’ll check which FDA certificate the regulator accepts.

Mailing

If you are using FedEx or UPS, please include a self-addressed air waybill for the return of your document.
Alternatively, you may use a USPS Priority Mail envelope with prepaid postage and a tracking number.
If you do not have a FedEx or UPS account, you can purchase an air waybill through this site in the next step.

Arab American Chamber of Commerce Headquarter Office

1330 New Hampshire Ave. NW, B1
Washington, D.C. 20036

(202) 347-5800

1 888-939-ARAB

Arab Chamber of Commerce

1615 Bay Head Rd.
Annapolis MD, 21409

(410) 349 - 1212