Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Apostille for Brazil
FDA Apostille for Brazil
Brazil has applied the Hague Apostille Convention since 14 August 2016. ANVISA's reliance routes for products already approved by the U.S. FDA expressly accept apostilled proof of that approval. Your FDA document needs a single U.S. Department of State apostille, with no Brazilian consulate step. Upload it and we return it apostilled by FedEx.
- Hague membersince 14 August 2016
- Apostilledocument route
- Portugueseofficial language
- 9 daysstandard processing
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time 9 business days
- No document shipping is required.
- You may update your own FedEx AWB or create a new one.
- Expedited processing times are offered.
- Credit card payments are accepted.
- The U.S. Department of State fee is already included.
- No separate U.S. Department of State form is needed.
- Track your order history and expenditures online.
Exp. Service fee$68 / Doc.
US Dept. of State fee$20 / Doc.
Total:$88 / Doc.
Why Brazil Asks for an Apostilled FDA Certificate
ANVISA, Brazil's health regulator, now relies on reviews by equivalent foreign authorities, and the U.S. FDA is one of them. Under Instruction IN 290/2024, in force since 3 June 2024, Class III and IV medical devices and IVDs cleared or approved by the FDA through a 510(k), PMA or De Novo can follow an optimized registration. The FDA's proof of authorization must be consularized or apostilled. For medicines, biologics and vaccines, IN 289/2024 does the same, again listing the FDA as an equivalent authority.
There's a useful detail in IN 290/2024: a sworn translation is required only when a document isn't in Portuguese, English or Spanish. Most FDA documents are in English, so the apostille is often the only extra step. Since the FDA is a federal agency, only the U.S. Department of State can apostille its documents. We take care of that and ship the result to you or straight to your Brazilian registration holder.
Which FDA Certificate Does Your Brazilian Importer Need?
Match your product to the Brazilian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Brazilian authority | FDA certificate |
|---|---|---|
| Medicines, biologics & vaccines | ANVISA, with an optimized reliance route under IN 289/2024 | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & IVDs | ANVISA, with an optimized reliance route for Class III–IV under IN 290/2024 | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food, ingredients & infant formula | ANVISA (food) and the Ministry of Agriculture (MAPA), depending on the product | Certificate to a Foreign Government (CFG), Health Certificate |
| Food supplements | ANVISA | Certificate of Free Sale (CFS) |
| Cosmetics, personal care & perfumes | ANVISA | Certificate for Cosmetics |
ANVISA regulates most of these categories, while some food products of animal or plant origin fall under the Ministry of Agriculture (MAPA). The reliance routes cover specific product classes, so your Brazilian registration holder will confirm which route applies and which FDA documents to apostille.
How the FDA Apostille for Brazil Works
The Hague Apostille Convention has been in force for Brazil since 14 August 2016, so a single apostille from the U.S. Department of State makes your FDA certificate valid there. There is no embassy visit, consular stamp or second legalization step.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Brazil as the destination.
We review it
We check that the certificate is complete, FDA-signed and ready for the State Department.
State Department apostille
We submit it to the Office of Authentications and track it until the apostille is issued.
FedEx delivery
The apostilled certificate ships to you, your importer or your agent in São Paulo or anywhere else.
Exporting to Brazil: What to Prepare
Reliance for Class III–IV devices
Under IN 290/2024, a high-risk device or IVD authorized by the FDA through 510(k), PMA or De Novo can rely on that review. The file needs consularized or apostilled proof of the FDA authorization (in practice, often an FDA Certificate to a Foreign Government covering the device), plus the U.S. instructions for use and a signed declaration, filed as a specific amendment.
English documents accepted
IN 290/2024 requires a sworn translation only for documents not in Portuguese, English or Spanish. FDA documents in English can generally be filed with just the apostille, which saves time and cost compared with many markets.
A Brazilian registration holder
Registrations are held by a company established in Brazil with an ANVISA operating authorization (AFE). Make sure the manufacturer and device names on your FDA documents match the holder's petition exactly, because ANVISA checks that the product is essentially identical.
INMETRO for electrical equipment
Many electromedical devices also need INMETRO conformity certification before ANVISA registration. Run that in parallel with the apostille, so neither holds up the other.
FDA Apostille Cost for Brazil
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $68 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | Paid by us on your behalf |
| Total | $88/ doc. | Standard processing: 9 business days. Expedited options available. |
FDA Apostille for Brazil: FAQs
Is Brazil a member of the Hague Apostille Convention?
Yes. Brazil joined by accession, and the Convention has applied there since 14 August 2016. A U.S. Department of State apostille is enough, so no Brazilian consulate legalization is required.
Does ANVISA rely on U.S. FDA approval?
Yes. IN 290/2024 lets Class III and IV medical devices and IVDs authorized by the FDA (510(k), PMA or De Novo) use an optimized registration. IN 289/2024 lists the FDA as an equivalent authority for medicines, biologics and vaccines.
Does the FDA document need to be apostilled for ANVISA?
Yes. Under IN 290/2024, the proof of authorization from the foreign authority must be consularized or apostilled. For U.S. products, that's usually an FDA certificate apostilled by the U.S. Department of State.
Do I need a sworn Portuguese translation?
Not for documents in English or Spanish under IN 290/2024. A sworn translation is required only for documents in other languages.
Which FDA documents do I need for Brazil?
For devices, apostilled proof of the FDA authorization, commonly an FDA Certificate to a Foreign Government (CFG) covering the device. For medicines, a CPP. A Certificate of Free Sale for food supplements and a Certificate for Cosmetics for cosmetic products. Your registration holder will confirm the exact set.
How long does an FDA apostille for Brazil take and what does it cost?
Standard processing takes 9 business days and costs $88per document: our $68 service fee plus the $20 U.S. Department of State fee. Expedited options are available.
FDA Certificates We Apostille for Brazil
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 Apostilled for Brazil
Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
9 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
Total:
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