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FDA Embassy Legalization for Madagascar

FDA Certificates · Madagascar

FDA Embassy Legalization for Madagascar

Madagascar is not a party to the Hague Apostille Convention, so FDA certificates for Malagasy regulators need embassy legalization. We obtain U.S. Department of State authentication and then legalization by the Embassy of Madagascar in Washington, and we FedEx the finished document to you or your importer in Antananarivo in about 16 business days.

  • Not in Hagueembassy legalization needed
  • Two-step legalizationdocument route
  • Malagasy and Frenchofficial language
  • 16 daysstandard processing
FDA Digital Certificate Sample

Submit Your FDA Certificate for Madagascar

Simply upload your FDA digital file, and you will receive your legalized document via FedEx.

Processing time 16 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 Madagascar fee$20 / Doc.
Total:$160 / Doc.

FedEx return shipping is available for completed documents after processing.

See expedited options →
Legalized FDA certificate sample

Why Madagascar Asks for a Legalized FDA Certificate

Medicines in Madagascar are regulated by the Agence du Médicament de Madagascar (AMM), which grants marketing authorizations under the Public Health Code. Registration used to be slow: a USAID-funded program found delays of 12 to 24 months and helped clear a backlog of 1,744 applications between 2019 and 2023. For medicines financed by partners and supplied through SALAMA, the national central purchasing agency, processing time fell from about two years to six months.

The agency has also modernized its systems. Its electronic regulatory information system, launched in 2024 for SALAMA's applications, is being extended to other products and renewals, and its registration guidance now follows the Common Technical Document format recommended by the Southern African Development Community. For U.S. exporters, a complete file still starts with official proof of approval in the country of origin, which for U.S. products is a legalized FDA certificate.

Which FDA Certificate Does Your Malagasy Importer Need?

Match your product to the Malagasy authority that reviews it and the FDA certificate that authority normally expects.

Product typeMalagasy authorityFDA certificate
MedicinesAgence du Médicament de Madagascar (AMM)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesAMM and the Ministry of Public HealthCertificate to a Foreign Government (CFG), Certificate of Exportability
Food & ingredientsMalagasy health and trade authorities, depending on the productCertificate to a Foreign Government (CFG), Health Certificate
Dietary supplementsAMM or food authorities, depending on classificationCertificate of Free Sale (CFS)
CosmeticsMinistry of Public Health; confirm the current route with your importerCertificate for Cosmetics

The AMM handles medicines and other pharmaceutical products, while food falls under health and trade authorities. Your Malagasy importer will confirm which authority reviews your product and which FDA certificate it needs.

How FDA Embassy Legalization for Madagascar Works

Madagascar 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 Madagascar.

  1. Upload your FDA certificate

    Send the digital certificate exactly as the FDA issued it and choose Madagascar as the destination.

  2. State Department authentication

    We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.

  3. Embassy legalization

    We take the authenticated certificate to the Embassy of Madagascar for legalization, which takes about 7 business days.

  4. FedEx delivery

    The legalized certificate ships to you, your importer or your agent in Antananarivo or anywhere else.

Exporting to Madagascar: What to Prepare

Faster routes for partner-funded supply

Medicines procured through SALAMA and international partners now move through registration in around six months, thanks to agreements recognizing international quality assurance. Commercial registrations can still take longer, so file complete documents early.

CTD-format dossiers

The AMM's guidance now follows the Common Technical Document format recommended in southern Africa. Files prepared for other SADC markets can often be adapted, with a legalized FDA certificate for Madagascar.

French translations

French is widely used in Malagasy administration alongside Malagasy. Expect to provide a French translation of your FDA certificate, prepared after the embassy legalization.

Allow for the embassy step

The Embassy of Madagascar step takes about 7 business days on top of roughly 9 at the State Department. Build that time into registration and tender deadlines.

FDA Embassy Legalization Cost for Madagascar

ItemAmountNotes
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 Madagascar fee$20 / doc.Embassy legalization, about 7 business days. Paid by us on your behalf
Total$160/ doc.Standard processing: 16 business days. Expedited options available.

FDA Embassy Legalization for Madagascar: FAQs

Does Madagascar accept apostilles?

No. Madagascar 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 Madagascar.

How long does FDA embassy legalization for Madagascar take?

About 16 business days: roughly 9 at the State Department and 7 at the Embassy of Madagascar, followed by FedEx delivery.

How much does it cost?

$160per document, combining our $120 service fee, the $20 State Department fee and the $20 Embassy of Madagascar fee.

Who regulates medicines in Madagascar?

The Agence du Médicament de Madagascar (AMM), which grants marketing authorizations and has moved to electronic, CTD-format submissions.

What is SALAMA?

SALAMA is Madagascar's national central purchasing agency for essential medicines. Medicines supplied through it and through international partners benefit from faster registration arrangements.

Which FDA certificate does Madagascar need?

Malagasy 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.

Health Certificate

Collagen and gelatin exports (EU health certificate or SRM certificate).

Nearby destinations

Get Your FDA Certificate Legalized for Madagascar

Upload your FDA certificate today and receive it legalized by FedEx in 16 business days, for $160per document with State Department and embassy fees included.

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FDA Digital Certificate Sample

Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.

Processing time

16 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 Madagascar fee

Total:

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