Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Embassy Legalization for Tunisia
FDA Embassy Legalization for Tunisia
Tunisian device and medicine files often call for documents legalized by the Embassy of Tunisia. We take your FDA certificate through U.S. Department of State authentication and legalization by the Tunisian Embassy in Washington, then FedEx it to you or your Tunisian distributor in about 14 business days.
- Hague member since 2018embassy stamp on request
- State Dept + embassydocument route
- Arabic (French widely used in regulation)official language
- 14 daysstandard processing
Submit Your FDA Documents for Tunisia
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 14 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 Tunisia fee$111 / Doc.
Total:$251 / Doc.
FedEx return shipping is available for completed documents.
See expedited options →Why Tunisia Asks for a Legalized FDA Certificate
Tunisia joined the Hague Apostille Convention with effect from 30 March 2018. Germany, Austria and Greece still object to its accession, but the United States does not, so a U.S. apostille is legally valid there. In practice, though, Tunisian regulatory guidance for medical devices states that the certificate of free sale must be legalized by the Tunisian Embassy, and that the manufacturer's power of attorney must be notarized and legalized the same way. This service provides that embassy-legalized FDA certificate.
Tunisia is moving health-product regulation from the Ministry of Health's Direction de la Pharmacie et du Médicament (DPM) to the new Agence nationale du médicament et des produits de santé (ANMPS). In January 2025, ANMPS launched a digital regulatory system with eCTD submissions for marketing authorizations and an online portal for licenses and filings. Existing DPM procedures still apply during the transition.
Which FDA Certificate Does Your Tunisian Importer Need?
Match your product to the Tunisian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Tunisian authority | FDA certificate |
|---|---|---|
| Medicines | ANMPS (formerly the DPM), Ministry of Health | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & IVDs | DPM / ANMPS, market authorization (AMC) | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Tunisian food safety and trade authorities, depending on the product | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | ANMPS or food authorities, depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | Ministry of Health; confirm the current route with your distributor | Certificate for Cosmetics |
Medicines and devices are moving from the DPM to ANMPS, while food falls under other authorities. Your Tunisian distributor will confirm which body reviews your product and whether an apostille or embassy legalization is expected.
How FDA Embassy Legalization for Tunisia Works
Tunisia accepts apostilles under the Hague Convention, but Tunisian guidance for device registration asks for free sale certificates legalized by the Tunisian Embassy. When your file needs that stamp, the FDA certificate follows a two-step route: U.S. Department of State authentication, then legalization by the Embassy of Tunisia in Washington. If your distributor confirms an apostille is acceptable, ask us about the apostille option.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Tunisia 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 Tunisia for legalization, which takes about 5 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Tunis or anywhere else.
Exporting to Tunisia: What to Prepare
No customs clearance without an AMC
Medical devices can't clear Tunisian customs without a valid market authorization (AMC), which is held by a local distributor or agent. The dossier includes a free sale certificate legalized by the Tunisian Embassy, ISO 13485 and product samples.
Choose your distributor carefully
Foreign manufacturers can't file directly. The AMC is tied to the local distributor's name, so switching distributors later may require a transfer consent letter. Agree the arrangement before you file.
eCTD and digital filing
ANMPS's digital system, launched in January 2025, moves marketing authorization applications to eCTD format through an online portal. Make sure your FDA certificates are available as clean digital copies alongside the legalized originals.
French and Arabic labeling
Device instructions for use are expected in French, with key warnings in Arabic for products used by patients. Translate your legalized FDA certificate if your distributor asks for it.
FDA Embassy Legalization Cost for Tunisia
| 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 Tunisia fee | $111 / doc. | Embassy legalization, about 5 business days. Paid by us on your behalf |
| Total | $251/ doc. | Standard processing: 14 business days. Expedited options available. |
FDA Embassy Legalization for Tunisia: FAQs
Does Tunisia accept apostilles?
Yes. Tunisia has been a party to the Hague Apostille Convention since 30 March 2018, and the United States did not object. However, Tunisian device guidance asks for free sale certificates legalized by the Tunisian Embassy, which this service provides.
When do I need embassy legalization for Tunisia?
When your distributor or the Tunisian regulator asks for the Embassy of Tunisia's stamp, as device registration guidance does for free sale certificates. If they confirm an apostille is enough, ask us about that route.
How long does FDA embassy legalization for Tunisia take?
About 14 business days: roughly 9 at the State Department and 5 at the Embassy of Tunisia, followed by FedEx delivery.
How much does it cost?
$251per document: our $120 service fee, the $20 U.S. Department of State fee and the $111 Embassy of Tunisia fee.
Who regulates medicines and devices in Tunisia?
Regulation is moving from the Ministry of Health's DPM to the Agence nationale du médicament et des produits de santé (ANMPS), which launched a digital regulatory system in January 2025.
Which FDA certificate does Tunisia need?
Tunisian files typically use 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 Tunisia
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 Tunisia
Upload your FDA certificate today and receive it legalized by FedEx in 14 business days, for $251per 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
14 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 Tunisia fee
Total:
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