Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Embassy Legalization for Tanzania
FDA Embassy Legalization for Tanzania
Tanzania is not a party to the Hague Apostille Convention, so FDA certificates for the Tanzania Medicines and Medical Devices Authority (TMDA) must be legalized. We have the certificate authenticated by the U.S. Department of State and legalized by the Embassy of the United Republic of Tanzania in Washington, then FedEx it to you or your local technical representative in Dar es Salaam in about 15 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Swahili and Englishofficial language
- 15 daysstandard processing
Prepare Your FDA Certificate for Tanzania
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 15 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 Tanzania fee$200 / Doc.
Total:$340 / Doc.
FedEx return shipping is available for completed documents.
See expedited options →Why Tanzania Asks for a Legalized FDA Certificate
Tanzania has one of Africa's most established medicines regulators. In 2018, its then Tanzania Food and Drugs Authority became the first regulator in Africa to reach WHO maturity level 3, a status the renamed Tanzania Medicines and Medical Devices Authority (TMDA) kept after a WHO verification audit in 2023. TMDA registers medicines, medical devices, diagnostics and vaccines on the mainland, and foreign manufacturers work through a local technical representative.
Since the 2019 reforms that created TMDA, oversight of food and cosmetics on the mainland has moved to the Tanzania Bureau of Standards (TBS), so exporters may deal with two agencies depending on the product. Zanzibar runs its own food and drug agency. For U.S. products, the dossier still begins with proof of approval in the country of origin, which is a legalized FDA certificate.
Which FDA Certificate Does Your Tanzanian Importer Need?
Match your product to the Tanzanian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Tanzanian authority | FDA certificate |
|---|---|---|
| Medicines & vaccines | Tanzania Medicines and Medical Devices Authority (TMDA) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & diagnostics | TMDA | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Tanzania Bureau of Standards (TBS) on the mainland | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | TMDA or TBS, depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | Tanzania Bureau of Standards (TBS) | Certificate for Cosmetics |
TMDA handles medicines, devices and diagnostics on the mainland, TBS handles food and cosmetics, and Zanzibar has its own agency. Your Tanzanian representative will confirm which authority reviews your product and which FDA certificate it needs.
How FDA Embassy Legalization for Tanzania Works
Tanzania 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 Tanzania.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Tanzania 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 Tanzania for legalization, which takes about 6 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Dar es Salaam or anywhere else.
Exporting to Tanzania: What to Prepare
Africa's first WHO level 3 regulator
TMDA's predecessor became the first African regulator to reach WHO maturity level 3 in 2018, and TMDA kept that status after WHO's 2023 verification. Expect structured, well-documented reviews, and send complete files from the start.
Two agencies on the mainland
Medicines and devices go to TMDA, while food and cosmetics go to the Tanzania Bureau of Standards. Check which agency covers your product before ordering certificates.
Zanzibar is separate
Zanzibar has its own food and drug agency. If you supply both the mainland and Zanzibar, ask your representative whether each needs its own registration and legalized certificate set.
East African alignment
Tanzania is part of the East African Community's medicines regulatory harmonization work, so files prepared for Kenya, Uganda or Rwanda can often be adapted.
FDA Embassy Legalization Cost for Tanzania
| 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 Tanzania fee | $200 / doc. | Embassy legalization, about 6 business days. Paid by us on your behalf |
| Total | $340/ doc. | Standard processing: 15 business days. Expedited options available. |
FDA Embassy Legalization for Tanzania: FAQs
Does Tanzania accept apostilles?
No. Tanzania 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 Tanzania.
How long does FDA embassy legalization for Tanzania take?
About 15 business days: roughly 9 at the U.S. Department of State and 6 at the Embassy of Tanzania, followed by FedEx delivery.
How much does it cost?
$340per document: our $120 service fee, the $20 State Department fee and the $200 Embassy of Tanzania fee.
Who regulates medicines in Tanzania?
The Tanzania Medicines and Medical Devices Authority (TMDA), which retains WHO maturity level 3 status. Food and cosmetics on the mainland fall under the Tanzania Bureau of Standards.
Do I need a local representative in Tanzania?
Yes. Foreign manufacturers register products with TMDA through a local technical representative based in Tanzania.
Which FDA certificate does Tanzania need?
Tanzanian 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 Tanzania
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.
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Get Your FDA Certificate Legalized for Tanzania
Upload your FDA certificate today and receive it legalized by FedEx in 15 business days, for $340per 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
15 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 Tanzania fee
Total:
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