Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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.
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
FedEx return shipping is available for completed documents after processing.
See expedited options →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.
Match your product to the Malagasy authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Malagasy authority | FDA certificate |
|---|---|---|
| Medicines | Agence du Médicament de Madagascar (AMM) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | AMM and the Ministry of Public Health | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Malagasy health and trade authorities, depending on the product | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | AMM or food authorities, depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | Ministry of Public Health; confirm the current route with your importer | Certificate 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.
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.
Send the digital certificate exactly as the FDA issued it and choose Madagascar 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 Madagascar for legalization, which takes about 7 business days.
The legalized certificate ships to you, your importer or your agent in Antananarivo or anywhere else.
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.
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 is widely used in Malagasy administration alongside Malagasy. Expect to provide a French translation of your FDA certificate, prepared after the embassy legalization.
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.
| 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 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. |
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.
About 16 business days: roughly 9 at the State Department and 7 at the Embassy of Madagascar, followed by FedEx delivery.
$160per document, combining our $120 service fee, the $20 State Department fee and the $20 Embassy of Madagascar fee.
The Agence du Médicament de Madagascar (AMM), which grants marketing authorizations and has moved to electronic, CTD-format submissions.
SALAMA is Madagascar's national central purchasing agency for essential medicines. Medicines supplied through it and through international partners benefit from faster registration arrangements.
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.
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 16 business days, for $160per 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.