Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Embassy Legalization for the UAE
FDA Embassy Legalization for the UAE
The United Arab Emirates does not accept apostilles, and its drug regulator expects a CPP to be attested by the UAE Embassy before it is submitted. We run your FDA certificate through Maryland certification, U.S. Department of State authentication and UAE Embassy legalization, then ship it by FedEx to you or your agent in about 23 business days.
- Not in Hagueembassy legalization needed
- Three-step legalizationdocument route
- Arabic (English widely used in business)official language
- 23 daysstandard processing
Start Your UAE FDA Legalization Online
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 23 business days
- We accept credit card payments.
- Track your order history and expenses online.
- Maryland, State Department 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$140 / Doc.
Maryland notary, court and state fees$15 / Doc.
U.S. Department of State fee$20 / Doc.
Embassy of the UAE fee$700 / Doc.
Total:$875 / Doc.
Once processing is complete, the legalized document is returned by FedEx.
See expedited options →Why the UAE Asks for a Legalized FDA Certificate
Medical product regulation in the UAE has moved to a new federal body. The Emirates Drug Establishment (EDE), headquartered in Abu Dhabi, now issues marketing authorizations for medicines and medical devices under Federal Decree-Law No. 38 of 2024, which came into force on 2 January 2025, and it took over dozens of core registration services from the Ministry of Health and Prevention (MOHAP). Its remit also covers cosmetics and nutritional supplements, so most FDA-regulated products now share one regulator.
Foreign manufacturers cannot register directly with EDE. A UAE-licensed pharmaceutical establishment, such as a medical warehouse or marketing office, acts as the local agent and files the dossier. That dossier needs a CPP or a certificate of free sale from the country of origin, and legal guides note that the CPP must be attested by the UAE Embassy before submission. For a U.S. product, we prepare that attested FDA certificate for your agent.
Which FDA Certificate Does Your Emirati Importer Need?
Match your product to the Emirati authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Emirati authority | FDA certificate |
|---|---|---|
| Medicines & biologicals | Emirates Drug Establishment (EDE) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | Emirates Drug Establishment (EDE) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & beverages | Federal and emirate food authorities, such as Dubai Municipality and the Abu Dhabi Agriculture and Food Safety Authority | Certificate to a Foreign Government (CFG), Health Certificate |
| Nutritional supplements | Emirates Drug Establishment (EDE) | Certificate of Free Sale (CFS) |
| Cosmetics | EDE, with emirate-level product registration in some emirates | Certificate for Cosmetics |
EDE now handles medicines, devices, supplements and cosmetics at federal level, while food is controlled jointly by federal and emirate-level authorities. Your UAE agent will confirm which body reviews your product and which FDA certificate it needs.
How FDA Embassy Legalization for the UAE Works
The UAE is not a party to the Hague Apostille Convention, so apostilles are not accepted. Your FDA certificate goes through a four-stage chain: Maryland notary, court and state certification, then U.S. Department of State authentication, then legalization by the Embassy of the UAE in Washington, and finally FedEx delivery.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose the UAE as the destination.
Maryland certification
We complete the Maryland notary, court and state certification, usually within about 1 business day.
U.S. Department of State
The State Department authenticates the certified document in about 9 business days.
Embassy of the UAE
The UAE Embassy legalizes the document in about 13 business days, after which we ship it by FedEx to you or your agent in Dubai or Abu Dhabi.
Exporting to the UAE: What to Prepare
From MOHAP to EDE
Registrations that used to go through MOHAP now go through the Emirates Drug Establishment, which has taken over its core medical product services. If your file was prepared for MOHAP, check with your agent that every certificate meets EDE's current requirements.
FDA clearance helps devices
For medical devices, FDA clearance or a CE certificate is not mandatory, but it strengthens the application and can reduce the depth of EDE's technical review. Device certificates are valid for five years, and renewals need an updated free sale certificate.
The longest chain in the Gulf
UAE legalization takes about 23 business days because the embassy step alone takes around 13. Order early for registrations and renewals, and keep a spare legalized certificate for tenders or free zone licensing.
Arabic and English labels
EDE expects bilingual Arabic and English labeling for medical products. English-language FDA certificates are normally accepted once legalized, but some authorities may still ask for an Arabic translation.
FDA Embassy Legalization Cost for the UAE
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $140 / doc. | Review, submission, tracking and FedEx dispatch |
| Maryland notary, court and state fees | $15 / doc. | Maryland certification, about 1 business day. Paid by us on your behalf |
| U.S. Department of State fee | $20 / doc. | State Department authentication, about 9 business days |
| Embassy of the UAE fee | $700 / doc. | Embassy legalization, about 13 business days. Paid by us on your behalf |
| Total | $875/ doc. | Standard processing: 23 business days. Expedited options available. |
FDA Embassy Legalization for the UAE: FAQs
Does the UAE accept an apostille on FDA certificates?
No. The UAE is not a member of the Hague Apostille Convention. FDA certificates go through Maryland certification, U.S. Department of State authentication and legalization by the Embassy of the UAE.
How long does FDA embassy legalization for the UAE take?
About 23 business days: roughly 1 for Maryland certification, 9 at the State Department and 13 at the UAE Embassy, followed by FedEx delivery.
Why does UAE legalization cost $875?
Most of the cost is the $700 Embassy of the UAE fee. The total is our $140 service fee, $15 in Maryland notary, court and state fees, the $20 State Department fee and the $700 embassy fee, all paid by us.
Who regulates medicines and devices in the UAE?
The Emirates Drug Establishment (EDE), which took over medical product registration from the Ministry of Health and Prevention under Federal Decree-Law No. 38 of 2024, in force since 2 January 2025.
Do I need a local agent in the UAE?
Yes. Foreign manufacturers cannot register products with EDE directly. A UAE-licensed pharmaceutical establishment must act as the local agent and hold the registration.
Which FDA certificate should I get for the UAE?
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 the UAE
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 the UAE
Upload your FDA certificate today and receive it legalized by FedEx in 23 business days, for $875per document with all Maryland, 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
23 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
Maryland notary, court and state fees
US Dept. of State fee
Embassy of UAE fee
Total:
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