Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Yemen is not a party to the Hague Apostille Convention, so an FDA certificate for Yemeni health authorities needs embassy legalization. We have it authenticated by the U.S. Department of State, then legalized by the Embassy of Yemen in Washington, and ship the finished document by FedEx to you or your Yemeni agent in about #totalDays business days.
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
The completed legalized document is returned by FedEx after processing.
See expedited options →Medicines and medical devices entering Yemen are regulated by the Supreme Board of Drugs and Medical Appliances (SBDMA), a body under the Ministry of Public Health and Population that dates back to a 1971 republican decree. Foreign manufacturers work through an authorized Yemeni agent, who registers with the Ministry of Industry and Trade, then registers the manufacturer and each product with the health authorities. A free sale certificate from the country of origin is a standard part of that file.
U.S. approvals carry particular weight in Yemen. For invasive medical devices, registration guides list FDA approval or a Gulf Cooperation Council certification as the accepted evidence; without either, the regulator may require an on-site inspection of the factory at the manufacturer's expense. A legalized FDA certificate is therefore one of the most valuable documents a U.S. exporter can provide, and we prepare it through the State Department and the Embassy of Yemen.
Match your product to the Yemeni authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Yemeni authority | FDA certificate |
|---|---|---|
| Medicines | Supreme Board of Drugs and Medical Appliances (SBDMA) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | SBDMA, under the Ministry of Public Health and Population | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Yemen Standardization, Metrology and Quality Control Organization (YSMO) and health authorities | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | SBDMA or food authorities, depending on how the product is classified | Certificate of Free Sale (CFS) |
| Cosmetics | Health and standards authorities; confirm with your importer | Certificate for Cosmetics |
Yemen's administration is divided, and regulatory offices operate in both Aden and Sana'a. Which authority reviews your file can depend on where the goods enter and are distributed, so confirm the current requirements with your Yemeni agent before ordering certificates.
Yemen 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 Yemen.
Send the digital certificate exactly as the FDA issued it and choose Yemen as the destination.
We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.
We take the authenticated certificate to the Embassy of Yemen for legalization, which takes about 7 business days.
The legalized certificate ships to you, your importer or your agent in Aden or Sana'a or anywhere else.
For invasive devices, Yemeni registration accepts FDA approval or GCC certification as proof of quality. Without one of them, an on-site inspection of the manufacturer may be required, so a legalized FDA certificate can save significant time and cost.
Device registrations are typically valid for five years, with review taking around three to six months. Plan renewals early, because the legalization chain alone takes about #totalDays business days.
YSMO adopts many Gulf (GSO) technical regulations as Yemeni standards, so labeling and shelf-life rules for food often mirror those of Saudi Arabia and the other Gulf states. Check that your product meets the relevant GSO standard before shipping.
Arabic is Yemen's official language, but registration guides note that documentation may generally be submitted in English. Your agent will tell you if a certified Arabic translation is needed for a particular file.
| Item | Amount | Notes |
|---|---|---|
| Our service fee | #serviceIdFee=1 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | #serviceIdFee=4 / doc. | State Department authentication, about 9 business days |
| Embassy of Yemen fee | #serviceIdFee=5 / doc. | Embassy legalization, about 7 business days. Paid by us on your behalf |
| Total | $#totalPrice / doc. | Standard processing: #totalDays business days. Expedited options available. |
No. Yemen has not joined the Hague Apostille Convention. FDA certificates are authenticated by the U.S. Department of State and then legalized by the Embassy of Yemen.
About #totalDays business days: roughly 9 at the State Department and 7 at the Embassy of Yemen, followed by FedEx delivery.
$#totalPrice per document: our #serviceIdFee=1 service fee, the #serviceIdFee=4 U.S. Department of State fee and #serviceIdFee=5 for the Embassy of Yemen step. We pay the government fees for you.
The Supreme Board of Drugs and Medical Appliances (SBDMA), under the Ministry of Public Health and Population, registers manufacturers, medicines and medical devices.
Yes. An authorized Yemeni agent registers with the Ministry of Industry and Trade and then registers your company and products with the health authorities.
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.
Dietary supplements, medical foods and foods for special dietary use.
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
The WHO-format certificate used to register human drugs.
Products made in the U.S. for export only.
Collagen and gelatin exports (EU health certificate or SRM certificate).
Skincare, makeup, haircare and fragrance products.
Upload your FDA certificate today and receive it legalized by FedEx in #totalDays business days, for $#totalPrice per document with State Department and embassy fees included.
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Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.