Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Embassy Legalization for Cuba
FDA Embassy Legalization for Cuba
Cuba is not a member of the Hague Apostille Convention, so FDA certificates for Cuban health authorities must be legalized. We have your certificate authenticated by the U.S. Department of State and then legalized by the Embassy of Cuba in Washington, and we return it by FedEx in about 13 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Spanishofficial language
- 13 daysstandard processing
Send Your FDA Certificate for Cuba
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 13 business days
- We accept credit card payments.
- Track your order history and expenses online.
- U.S. Department of State and embassy fees are already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee$120 / Doc.
US Dept. of State fee$20 / Doc.
Embassy of Cuba fee$300 / Doc.
Total:$440 / Doc.
FedEx return shipping is available for completed documents after processing.
See expedited options →Why Cuba Asks for a Legalized FDA Certificate
Medicines, medical equipment and medical devices entering Cuba are controlled by CECMED, the Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, under Cuba's Ministry of Public Health (MINSAP). A product must be registered before it can be imported, only importers accredited with Cuba's foreign trade ministry and licensed by CECMED may apply, and CECMED issues an import certificate for each shipment through its SICECMED electronic system.
U.S. exporters face a second set of rules at home. The U.S. maintains a general policy of denial for exports to Cuba, but the Bureau of Industry and Security states that medicines and medical devices, whether sold or donated, are generally approved, while agricultural commodities, including food, can ship under License Exception AGR after prior notice to BIS. When a Cuban buyer needs proof that a U.S. product is approved and sold at home, the FDA certificate legalized by the Cuban Embassy is that document.
Which FDA Certificate Does Your Cuban Importer Need?
Match your product to the Cuban authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Cuban authority | FDA certificate |
|---|---|---|
| Medicines | CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical equipment & devices | CECMED | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Ministry of Public Health (MINSAP) and Cuban food and trade authorities | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | CECMED or MINSAP food authorities, depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | MINSAP and CECMED, depending on the product | Certificate for Cosmetics |
CECMED controls medicines, equipment and devices, and food falls under MINSAP and Cuba's trade authorities. Imports go through accredited Cuban entities, which will confirm which FDA certificate they need.
How FDA Embassy Legalization for Cuba Works
Cuba is not a party to the Hague Apostille Convention, so it does not accept apostilles. Your FDA certificate is first authenticated by the U.S. Department of State and then legalized by the Embassy of Cuba.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Cuba as the destination.
State Department authentication
We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.
Embassy legalization
We take the authenticated certificate to the Embassy of Cuba for legalization, which takes about 4 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Havana or anywhere else.
Exporting to Cuba: What to Prepare
Check U.S. export rules first
Before shipping anything to Cuba, confirm the U.S. authorization that applies. BIS says medicines and medical devices are generally approved under a license, while food and other agricultural commodities may use License Exception AGR with prior notification. OFAC rules can also apply, so take advice if you're unsure.
Accredited importers only
Only Cuban entities accredited with the foreign trade ministry and licensed by CECMED can import medicines, equipment and devices. Your counterpart in Cuba will normally hold those accreditations and request the documents they need from you.
Batch-level quality documents
For each shipment, CECMED expects the manufacturer's certificate of analysis or a supplier quality certificate. Medicines arriving with less than a year of shelf life also need a letter from the receiving institution.
Spanish translations
Spanish is Cuba's official language. Plan for a Spanish translation of your FDA certificate after legalization, and label samples or inserts not in Spanish may need to be submitted with the import application.
FDA Embassy Legalization Cost for Cuba
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $120 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | State Department authentication, about 9 business days |
| Embassy of Cuba fee | $300 / doc. | Embassy legalization, about 4 business days. Paid by us on your behalf |
| Total | $440/ doc. | Standard processing: 13 business days. Expedited options available. |
FDA Embassy Legalization for Cuba: FAQs
Does Cuba accept apostilles?
No. Cuba is not a party to the Hague Apostille Convention, so FDA certificates need U.S. Department of State authentication followed by legalization at the Embassy of Cuba.
How long does FDA embassy legalization for Cuba take?
About 13 business days: roughly 9 at the State Department and 4 at the Embassy of Cuba, followed by FedEx delivery.
How much does it cost?
$440per document: our $120 service fee, the $20 U.S. Department of State fee and the $300 Embassy of Cuba fee, which makes up most of the total.
Can U.S. companies export medicines and medical devices to Cuba?
Generally yes, with authorization. BIS states that exports of medicines and medical devices to Cuba, sold or donated, are generally approved, while food may use License Exception AGR. Legalizing your FDA certificate does not replace those U.S. export authorizations.
Who regulates medicines and devices in Cuba?
CECMED, the state control center for medicines, equipment and medical devices under the Ministry of Public Health. It registers products and issues import certificates for each shipment.
Which FDA certificate does Cuba need?
Usually a CPP for medicines, a CFG for devices and foods, a Certificate of Free Sale for supplements and a Certificate for Cosmetics for cosmetic products. Products not sold in the U.S. need a Certificate of Exportability.
FDA Certificates We Legalize for Cuba
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Legalized for Cuba
Upload your FDA certificate today and receive it legalized by FedEx in 13 business days, for $440per document with State Department and embassy fees included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
13 business days
- We accept credit card payments.
- Track your order history and expenses online.
- The U.S. Department of State fee is already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee
US Dept. of State fee
Embassy of Cuba fee
Total:
Click here toupload your first FDA digital filePDF only · or drag and drop it here