Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Embassy Legalization for Zimbabwe
FDA Embassy Legalization for Zimbabwe
Because Zimbabwe has not acceded to the Hague Apostille Convention, FDA certificates used before the Medicines Control Authority of Zimbabwe (MCAZ) go through full consular legalization. We obtain U.S. Department of State authentication, present the document to the Embassy of the Republic of Zimbabwe in Washington, and FedEx the finished certificate to you or your Harare applicant in about 18 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- English (one of 16 official languages)official language
- 18 daysstandard processing
Prepare Your FDA Certificate for Zimbabwe
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 18 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 Zimbabwe fee$250 / Doc.
Total:$390 / Doc.
Upload a digital copy of the FDA certificate online to begin the legalization request.
See expedited options →Why Zimbabwe Asks for a Legalized FDA Certificate
MCAZ traces its roots to the Drugs Control Council set up on 1 September 1969 and today operates under the Medicines and Allied Substances Control Act [Chapter 15:03]. It authorises human and veterinary medicines, tests products in its own quality-control laboratory, licenses premises and runs pharmacovigilance. In June 2024, after a benchmarking process that began in 2021, WHO announced that Zimbabwe's regulatory system had reached maturity level 3, making it the sixth African country to do so.
MCAZ has since said it is pursuing maturity level 4, the top tier of WHO's Global Benchmarking Tool, through digital dossier submission, stronger pharmacovigilance and data-sharing agreements with peer regulators. Zimbabwe is also one of the four countries that launched ZAZIBONA, the southern African joint-assessment programme. For a regulator with that profile, an FDA certificate carrying the Zimbabwean Embassy's legalization stamp is a standard part of a complete U.S. dossier.
Which FDA Certificate Does Your Zimbabwean Importer Need?
Match your product to the Zimbabwean authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Zimbabwean authority | FDA certificate |
|---|---|---|
| Human medicines & vaccines | Medicines Control Authority of Zimbabwe (MCAZ) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | MCAZ; confirm current device requirements with your local applicant | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Ministry of Health and Child Care food control services and port health | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements & complementary medicines | MCAZ or food control, depending on claims and classification | Certificate of Free Sale (CFS) |
| Cosmetics | Health authorities; confirm the route with your importer | Certificate for Cosmetics |
MCAZ covers medicines (including veterinary products) and related health products, while foods fall under Ministry of Health and Child Care controls. Your Zimbabwean applicant will confirm which body reviews your product and which FDA certificate it expects.
How FDA Embassy Legalization for Zimbabwe Works
Zimbabwe 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 Zimbabwe.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Zimbabwe 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 Zimbabwe for legalization, which takes about 9 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Harare or anywhere else.
Exporting to Zimbabwe: What to Prepare
Longest embassy step in the region
The Embassy of Zimbabwe takes about 9 business days, as long as the State Department, so the full route runs 18 business days. Start legalization before your other dossier documents are final.
Higher consular fee
At $250 the Zimbabwean Embassy fee is well above neighbours such as Zambia. Order the right certificate type the first time so you don't pay the embassy fee twice.
A regulator aiming for the top tier
MCAZ reached WHO maturity level 3 in 2024 and is working toward level 4. Expect thorough checks on consistency between your FDA certificate, labels and dossier.
Regional work-sharing
Through ZAZIBONA, a product assessed jointly can move faster across Zimbabwe, Zambia, Botswana, Namibia and other members. Plan legalized certificates for every country you will register in.
FDA Embassy Legalization Cost for Zimbabwe
| 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 Zimbabwe fee | $250 / doc. | Embassy legalization, about 9 business days. Paid by us on your behalf |
| Total | $390 / doc. | Standard processing: 18 business days. Expedited options available. |
FDA Embassy Legalization for Zimbabwe: FAQs
Is an apostille enough for Zimbabwe?
No. Zimbabwe isn't a Hague Apostille Convention member, so FDA certificates need State Department authentication and then legalization by the Embassy of Zimbabwe in Washington.
How long is processing for Zimbabwe?
About 18 business days: 9 at the U.S. Department of State and 9 at the Embassy of Zimbabwe, then FedEx delivery.
How much is FDA legalization for Zimbabwe?
$390 per document: our $120 service fee, the $20 State Department fee and the $250 Embassy of Zimbabwe fee.
Which agency regulates medicines in Zimbabwe?
The Medicines Control Authority of Zimbabwe (MCAZ), working under the Medicines and Allied Substances Control Act [Chapter 15:03]. WHO confirmed Zimbabwe at maturity level 3 in June 2024.
Is MCAZ part of ZAZIBONA?
Yes. Zimbabwe is a founding member of ZAZIBONA, the SADC initiative in which regulators assess medicine applications together.
What FDA certificate should I legalize for Zimbabwe?
For MCAZ medicine files, a CPP; for devices and foods, a CFG; for supplements, a Certificate of Free Sale; and for cosmetics, a Certificate for Cosmetics. Exporters of products not sold domestically need a Certificate of Exportability.
FDA Certificates We Legalize for Zimbabwe
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 Zimbabwe
Upload your FDA certificate today and receive it legalized by FedEx in 18 business days, for $390 per 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 Zambia fee
Total:
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