Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
When a Burundian importer, tender or authority asks for an FDA certificate stamped by the Embassy of the Republic of Burundi, we arrange it. Your certificate is authenticated by the U.S. Department of State, legalized by the embassy in Washington and sent by FedEx to you or your representative in Bujumbura in about 13 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 →Burundi joined the Hague Apostille Convention with effect from 13 February 2015. Austria, Germany, the Czech Republic and Poland objected to its accession, but the United States did not, so a State Department apostille is legally valid for U.S. documents used in Burundi. Even so, some buyers, procurement bodies and offices still ask for the embassy's legalization stamp, especially on documents for public tenders. This service provides that embassy-legalized version for FDA certificates.
On the regulatory side, Burundi brought medicines, food and other health products under one authority. Decree No. 100/039 of 26 February 2021 created ABREMA, the Autorité Burundaise de Régulation des Médicaments à usage humain et des Aliments. It oversees human medicines, foods, cosmetics, dietary products, herbal medicines and medical devices, and it enforces registration requirements for imported medical products.
Match your product to the Burundian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Burundian authority | FDA certificate |
|---|---|---|
| Medicines | ABREMA (Autorité Burundaise de Régulation des Médicaments et des Aliments) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | ABREMA | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | ABREMA | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary products & supplements | ABREMA | Certificate of Free Sale (CFS) |
| Cosmetics | ABREMA | Certificate for Cosmetics |
ABREMA covers medicines, devices, food, supplements and cosmetics in a single agency. Your Burundian representative will confirm which FDA certificate the file needs and whether an apostille or embassy legalization is expected.
Burundi accepts apostilles under the Hague Convention, but when your importer, a tender committee or an authority asks for embassy legalization, the FDA certificate follows a two-step route: U.S. Department of State authentication, then legalization by the Embassy of Burundi in Washington. If your representative confirms that an apostille alone is enough, ask us about the apostille option.
Send the digital certificate exactly as the FDA issued it and choose Burundi 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 Burundi for legalization, which takes about 4 business days.
The legalized certificate ships to you, your importer or your agent in Bujumbura or anywhere else.
An apostille is legally valid in Burundi for U.S. documents. If your buyer or a tender document specifically asks for embassy legalization, follow it, because a file that doesn't match the tender wording can be rejected. Check before ordering so you only pay for the route you need.
Public-sector medicines and devices are largely procured through CAMEBU, Burundi's central purchasing agency for essential medicines. Selling to CAMEBU or donor programs also requires that the item appear on the national essential lists, whose 2025 device list has 923 entries.
Commercial registration of a medical device with ABREMA requires a licensed local representative in Bujumbura. The technical dossier typically includes ISO 13485 and CE or FDA evidence, packaging labels and French-language instructions for use.
Burundi is a member of the East African Community and is aligning its rules with EAC guidelines for medicine and device registration. Over time, this should make files prepared for Kenya, Tanzania or Rwanda easier to adapt.
| 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 Burundi fee | $40 / doc. | Embassy legalization, about 4 business days. Paid by us on your behalf |
| Total | $180 / doc. | Standard processing: 13 business days. Expedited options available. |
Yes. Burundi has been a party to the Hague Apostille Convention since 13 February 2015, and the United States did not object. Some importers and tenders still ask for embassy legalization, which this service provides.
When your buyer, a tender committee or an authority specifically asks for the Embassy of Burundi's stamp. If they accept an apostille, choose the apostille route instead.
About 13 business days: roughly 9 at the U.S. Department of State and 4 at the Embassy of Burundi, followed by FedEx delivery.
$180 per document: our $120 service fee, the $20 U.S. Department of State fee and the $40 Embassy of Burundi fee.
ABREMA, created by Decree No. 100/039 of 26 February 2021. It covers medicines, food, cosmetics, dietary products, herbal medicines and medical devices.
Usually 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 13 business days, for $180 per 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.