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FDA Apostille for Argentina

FDA Certificates · Argentina

FDA Apostille for Argentina

Argentina has applied the Hague Apostille Convention since 18 February 1988. An FDA export certificate for an ANMAT file in Buenos Aires needs one U.S. Department of State apostille, with no Argentine consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.

  • Hague membersince 18 February 1988
  • Apostilledocument route
  • Spanishofficial language
  • 9 daysstandard processing
FDA Digital Certificate Sample

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.
See expedited options →
FDA Certificate Sample 1 FDA Certificate Sample 2

Why Argentina Asks for an Apostilled FDA Certificate

Argentina has opened up its import rules for U.S. products. Decree 35 of 2025 lists the United States among the countries with high sanitary standards, so U.S. food can enter on a sworn declaration and import notice instead of the full local registration path. In 2026, ANMAT Disposition 236, which implements Decree 892 of 2025, moved lower-risk medical devices, cosmetics and hygiene products to a sworn-declaration registration, with no local testing for products already authorized in a reference country.

Both routes rest on the same kind of document: a certificate of free sale, or equivalent, from the health authority of the country of origin. For U.S. products, that's an FDA certificate. Under the 2026 rules for devices and cosmetics, the free sale certificate can be no more than 24 months old. The FDA is a federal agency, so only the U.S. Department of State can apostille its certificates. We take care of that and ship the result to you or straight to your Argentine importer.

Which FDA Certificate Does Your Argentine Importer Need?

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

Product typeArgentine authorityFDA certificate
MedicinesANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devices & in-vitro diagnosticsANMAT, with sworn-declaration registration for Class I and II devicesCertificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaANMAT's National Food Institute (INAL), under Decree 35 of 2025Certificate to a Foreign Government (CFG), Health Certificate
Dietary supplements & medical foodsINAL, which keeps closer control over these higher-risk foodsCertificate of Free Sale (CFS)
Cosmetics, hygiene & perfumesANMAT, with sworn-declaration registrationCertificate for Cosmetics

ANMAT and its National Food Institute (INAL) have been rolling out simplified procedures since 2025, with deadlines set by decree. Higher-risk categories such as infant formula, supplements and foods for special medical purposes stay under closer control. Your Argentine importer will confirm the current route for your product.

How the FDA Apostille for Argentina Works

The Hague Apostille Convention has been in force for Argentina since 18 February 1988, 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.

  1. Upload your FDA certificate

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

  2. We review it

    We check that the certificate is complete, FDA-signed and ready for the State Department.

  3. State Department apostille

    We submit it to the Office of Authentications and track it until the apostille is issued.

  4. FedEx delivery

    The apostilled certificate ships to you, your importer or your agent in Buenos Aires or anywhere else.

Exporting to Argentina: What to Prepare

Keep the free sale certificate fresh

Under ANMAT Disposition 236 of 2026, the free sale certificate from the country of origin can be at most 24 months old for medical devices, cosmetics and hygiene products. Request a recent FDA certificate and apostille it promptly, so it stays valid throughout your filing.

U.S. food: sworn declaration route

Because the U.S. is on Argentina's list of high-standard countries, food for sale can enter through a sworn declaration and an import notice on the TAD platform, backed by a free sale or marketing certificate. INAL still inspects after entry and can remove non-compliant products.

Licensed importers only

Only companies licensed by ANMAT can import and sell regulated products in Argentina. Make sure your importer holds the right license, and that the manufacturer and product names on your FDA certificate match its declaration.

Spanish and the traductor público

Argentine authorities work in Spanish, and foreign documents are usually translated by a certified public translator (traductor público). Apostille the FDA certificate first, then translate it, so the apostille is covered.

FDA Apostille Cost for Argentina

ItemAmountNotes
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 Argentina: FAQs

Is Argentina a member of the Hague Apostille Convention?

Yes. Argentina joined by accession, and the Convention has applied there since 18 February 1988. A U.S. Department of State apostille is enough, so no Argentine consulate legalization is required.

Has Argentina simplified imports of U.S. food?

Yes. Decree 35 of 2025 lists the United States among the countries with high sanitary standards, so U.S. food can enter on a sworn declaration and import notice, backed by a certificate of free sale or equivalent. Higher-risk foods such as infant formula and supplements stay under closer control.

What changed for medical devices and cosmetics in 2026?

ANMAT Disposition 236 of 2026, implementing Decree 892 of 2025, moved Class I and II devices, lower-risk diagnostics, cosmetics and hygiene products to a sworn-declaration registration. Products authorized in a reference country are exempt from local testing, but need a free sale certificate no more than 24 months old.

How old can my FDA free sale certificate be for ANMAT?

For products under Disposition 236 of 2026, no more than 24 months old. Request a recent FDA certificate and apostille it promptly.

Which FDA certificate do I need for Argentina?

A CPP for medicines, a CFG or Certificate of Free Sale for medical devices and foods, a Certificate of Free Sale for dietary supplements, and a Certificate for Cosmetics for cosmetic and hygiene products. Products not sold in the U.S. need a Certificate of Exportability.

How long does an FDA apostille for Argentina 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.

Health Certificate

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

Nearby destinations

Get Your FDA Certificate Apostilled for Argentina

Upload your FDA certificate today and receive it apostilled by FedEx in 9 business days, for $88per document with the State Department fee 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

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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