Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Apostille for Saudi Arabia
FDA Apostille for Saudi Arabia
Saudi Arabia has accepted apostilles since 7 December 2022. That removed the Saudi embassy legalization U.S. exporters used to arrange for every FDA certificate. Today a single U.S. Department of State apostille is all an FDA certificate needs for an SFDA file in Riyadh. Upload the digital certificate and we return it apostilled by FedEx.
- Hague membersince 7 December 2022
- Apostilledocument route
- Arabicofficial language
- 9 daysstandard processing
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time 9 business days
- No document shipping is required.
- You may update your own FedEx AWB or create a new one.
- Expedited processing times are offered.
- Credit card payments are accepted.
- The U.S. Department of State fee is already included.
- No separate U.S. Department of State form is needed.
- Track your order history and expenditures online.
Exp. Service fee$68 / Doc.
US Dept. of State fee$20 / Doc.
Total:$88 / Doc.
Why Saudi Arabia Asks for an Apostilled FDA Certificate
The Saudi Food and Drug Authority (SFDA) regulates medicines, medical devices, food, supplements and cosmetics, and it is one of the region's most demanding regulators. For proof that a product is registered in its country of origin, SFDA follows the GCC data requirements, which accept a Certificate of a Pharmaceutical Product (CPP) or a free sale certificate. For U.S. products, that document comes from the FDA.
Before Saudi Arabia joined the Hague Convention, these certificates went through State Department authentication and then Saudi embassy legalization. Now the State Department apostille alone completes the process. The FDA is a federal agency, so no U.S. state can apostille its certificates. We prepare and track the request and ship the result to you or straight to your Saudi agent.
FDA certificates we apostille for Saudi Arabia
Which FDA Certificate Does Your Saudi Importer Need?
Match your product to the Saudi authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Saudi authority | FDA certificate |
|---|---|---|
| Medicines | Saudi Food and Drug Authority (SFDA), Drug Sector | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | SFDA, Medical Devices Sector (Medical Device Marketing Authorization) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | SFDA, Food Sector | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & health products | SFDA | Certificate of Free Sale (CFS) |
| Cosmetics & personal care | SFDA, cosmetic product notification | Certificate for Cosmetics |
The SFDA covers every product group, but each sector has its own registration system and guidance. Your Saudi authorized representative or local agent will confirm the certificate and wording the relevant sector expects.
How the FDA Apostille for Saudi Arabia Works
The Hague Apostille Convention has been in force for Saudi Arabia since 7 December 2022, so a single apostille from the U.S. Department of State makes your FDA certificate valid there. There is no embassy visit, consular stamp or second legalization step.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Saudi Arabia as the destination.
We review it
We check that the certificate is complete, FDA-signed and ready for the State Department.
State Department apostille
We submit it to the Office of Authentications and track it until the apostille is issued.
FedEx delivery
The apostilled certificate ships to you, your importer or your agent in Riyadh or anywhere else.
Exporting to Saudi Arabia: What to Prepare
Fast routes for FDA-approved drugs
SFDA offers two expedited routes for new medicines already approved by reference regulators. The Verification route takes 30 working days and needs approval by both the U.S. FDA and the EMA. The Abridged route takes 60 working days and needs approval by either one. Both require the product to be approved and marketed by the reference agency, and you must apply within two years of the reference approval.
Proof of registration in the file
Under the GCC data requirements that SFDA applies, the registration file includes a CPP or free sale certificate from the country of origin. Have the FDA certificate apostilled before your agent uploads it, so it doesn't stall the review.
Arabic and English
Arabic is the official language, but SFDA works extensively in English, and FDA certificates are issued in English. Translation is not usually needed for the certificate itself, while product labels and leaflets follow SFDA's Arabic labeling rules.
A Saudi representative
Foreign manufacturers work through a local agent or authorized representative registered with SFDA. Make sure the manufacturer and product names on your FDA certificate match the details in their SFDA account.
FDA Apostille Cost for Saudi Arabia
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $68 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $88/ doc. | Standard processing: 9 business days. Expedited options available. |
FDA Apostille for Saudi Arabia: FAQs
Is Saudi Arabia a member of the Hague Apostille Convention?
Yes. Saudi Arabia joined by accession, and the Convention has applied there since 7 December 2022. A U.S. Department of State apostille is enough, so Saudi embassy legalization is no longer required.
Do I still need Saudi embassy legalization for FDA certificates?
No. Embassy legalization was required before December 2022. Now an apostille from the U.S. Department of State replaces it for U.S. federal documents such as FDA certificates.
What are SFDA's Verification and Abridged routes?
They are expedited registration routes for new medicines already approved by reference regulators. Verification (30 working days) needs both U.S. FDA and EMA approval. Abridged (60 working days) needs approval from either one. The application must be filed within two years of the reference approval.
Which FDA certificate does SFDA accept as proof of registration?
SFDA follows the GCC data requirements, which accept a Certificate of a Pharmaceutical Product (CPP) or a free sale certificate. Medical devices typically use a CFG, supplements a Certificate of Free Sale, and cosmetics a Certificate for Cosmetics.
Does my FDA certificate need an Arabic translation?
Usually not. SFDA works extensively in English, and FDA certificates are issued in English. Labels and leaflets, however, must follow SFDA's Arabic requirements.
How long does an FDA apostille for Saudi Arabia take and what does it cost?
Standard processing takes 9 business days and costs $88per document: our $68 service fee plus the $20 U.S. Department of State fee. Expedited options are available.
FDA Certificates We Apostille for Saudi Arabia
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 Apostilled for Saudi Arabia
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
9 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
Total:
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