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FDA Apostille for Paraguay

FDA Certificates · Paraguay

FDA Apostille for Paraguay

Paraguay has applied the Hague Apostille Convention since 30 August 2014. An FDA export certificate for a DINAVISA file in Asunción needs a single U.S. Department of State apostille, with no Paraguayan consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.

  • Hague membersince 30 August 2014
  • Apostilledocument route
  • Spanish & Guaraníofficial 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 Paraguay Asks for an Apostilled FDA Certificate

Paraguay reorganized its health regulator under Law 6788 of 2021. That law made DINAVISA, the National Directorate of Health Surveillance, an autonomous agency responsible for medicines, medical devices, reagents, cosmetics, hygiene and household products. Customs won't clear these products without DINAVISA authorization, so registration comes first, and registration files for U.S. products rely on FDA certificates.

DINAVISA has been issuing new product rules. Decree 2942 of 2024, for example, created a two-tier system for cosmetics and personal-care products, with registrations valid for five years. Whatever the product, the FDA is a federal agency, so its certificates are apostilled only by the U.S. Department of State. We take care of that and ship the result to you or straight to your Paraguayan registration holder.

Which FDA Certificate Does Your Paraguayan Importer Need?

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

Product typeParaguayan authorityFDA certificate
MedicinesDINAVISA (Dirección Nacional de Vigilancia Sanitaria)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devices & reagentsDINAVISACertificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaNational Institute of Food and Nutrition (INAN)Certificate to a Foreign Government (CFG), Health Certificate
Dietary supplements & medical foodsINAN or DINAVISA, depending on how the product is classifiedCertificate of Free Sale (CFS)
Cosmetics, hygiene & perfumesDINAVISA, under Decree 2942 of 2024Certificate for Cosmetics

DINAVISA regulates medicines, devices, cosmetics and household products, and food is handled by INAN. Product classification decides which one reviews your file, so your Paraguayan registration holder will confirm the authority and the FDA certificate it expects.

How the FDA Apostille for Paraguay Works

The Hague Apostille Convention has been in force for Paraguay since 30 August 2014, 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 Paraguay 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 Asunción or anywhere else.

Exporting to Paraguay: What to Prepare

Two tiers for cosmetics

Under Decree 2942 of 2024, lower-risk Grade 1 cosmetics and hygiene products get a mandatory sanitary notification based on a sworn declaration. Grade 2 products go through a full technical evaluation and receive a sanitary registration certificate. Both are valid for five years.

No customs clearance without DINAVISA

Paraguayan customs will not release regulated health and cosmetic products without prior DINAVISA authorization. Have your registration, and the apostilled FDA certificate behind it, in place before you ship.

Spanish documents

Spanish and Guaraní are both official languages, and regulatory files are prepared in Spanish. Foreign documents are generally translated by a public translator. Apostille the FDA certificate first, then translate it, so the apostille is covered.

Mercosur routes

Paraguay is a founding Mercosur member alongside Argentina, Brazil and Uruguay. Many exporters reach Paraguay through distributors in those markets. Each country accepts apostilles but normally wants its own apostilled original.

FDA Apostille Cost for Paraguay

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 Paraguay: FAQs

Is Paraguay a member of the Hague Apostille Convention?

Yes. Paraguay joined by accession, and the Convention has applied there since 30 August 2014. A U.S. Department of State apostille is enough, so no Paraguayan consulate legalization is required.

What is DINAVISA?

DINAVISA is Paraguay's National Directorate of Health Surveillance. Under Law 6788 of 2021 it is an autonomous agency regulating medicines, medical devices, reagents, cosmetics, hygiene and household products.

How are cosmetics registered in Paraguay?

Under Decree 2942 of 2024, Grade 1 products receive a mandatory sanitary notification and Grade 2 products receive a sanitary registration certificate after evaluation. Both are valid for five years.

Does my FDA certificate need a Spanish translation?

Usually yes. Paraguayan files are prepared in Spanish, and foreign documents are generally translated by a public translator. Translate after the apostille is attached.

Which FDA certificate do I need for Paraguay?

A CPP for medicines, a CFG for medical devices and conventional 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 Paraguay 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 Paraguay

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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