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FDA Apostille for Peru

FDA Certificates · Peru

FDA Apostille for Peru

Peru has applied the Hague Apostille Convention since 30 September 2010. An FDA export certificate for a DIGEMID or DIGESA file in Lima needs a single U.S. Department of State apostille, with no Peruvian consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.

  • Hague membersince 30 September 2010
  • 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 Peru Asks for an Apostilled FDA Certificate

Peru gives products from the United States a regulatory advantage. Its pharmaceutical registration rules list the U.S. among the High Sanitary Surveillance Countries (Países de Alta Vigilancia Sanitaria, or PAVS), a list confirmed in DIGEMID's Supreme Decree DS 018-2019-SA. Peru also accepts GMP certificates issued by PAVS authorities, so registering a U.S.-made product generally relies on U.S. documents rather than a separate Peruvian inspection.

In May 2024, Peru's Congress approved a law to speed up access to medicines and medical devices for rare diseases and cancer that are registered in PAVS countries, based on the foreign registration certificate and a certificate of free sale. For U.S. products, those certificates come from the FDA, a federal agency, so only the U.S. Department of State can apostille them. We handle that and ship the result to you or your Peruvian registration holder.

Which FDA Certificate Does Your Peruvian Importer Need?

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

Product typePeruvian authorityFDA certificate
Medicines & biologicalsDIGEMID (Dirección General de Medicamentos, Insumos y Drogas)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesDIGEMIDCertificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaDIGESA (Dirección General de Salud Ambiental e Inocuidad Alimentaria)Certificate to a Foreign Government (CFG), Health Certificate
Dietary supplementsDIGEMID or DIGESA, depending on how the product is classifiedCertificate of Free Sale (CFS)
Cosmetics & personal careDIGEMID, applying Andean Community (CAN) notification rulesCertificate for Cosmetics

DIGEMID handles medicines, devices and cosmetics, and DIGESA handles food. Supplements fall to one or the other depending on composition and claims. Your Peruvian registration holder will confirm the authority and the FDA certificate it expects.

How the FDA Apostille for Peru Works

The Hague Apostille Convention has been in force for Peru since 30 September 2010, 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 Peru 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 Lima or anywhere else.

Exporting to Peru: What to Prepare

The PAVS advantage

Because the U.S. is on Peru's list of High Sanitary Surveillance Countries, DIGEMID accepts GMP certificates from U.S. authorities and applies a lighter evaluation to products registered there. Your apostilled FDA certificates are therefore the core of the file, so make sure they're current and match the product exactly.

Faster access for rare diseases and cancer

The 2024 law approved by Congress targets medicines and devices for rare or orphan diseases and cancer that are registered in PAVS countries, and bases approval on the foreign registration certificate and a certificate of free sale. Confirm with your registration holder how the procedure currently applies.

Spanish translation

Peruvian authorities work in Spanish, and foreign documents are generally submitted with an official or certified translation. Apostille the FDA certificate first, then translate it, so the apostille is covered.

Andean cosmetics rules

Cosmetics in Peru follow the Andean Community's mandatory notification system, shared with Colombia, Ecuador and Bolivia. Each country still processes its own notification, so plan one apostilled certificate per country.

FDA Apostille Cost for Peru

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 Peru: FAQs

Is Peru a member of the Hague Apostille Convention?

Yes. Peru joined by accession, and the Convention has applied there since 30 September 2010. A U.S. Department of State apostille is enough, so no Peruvian consulate legalization is required.

Is the U.S. a high sanitary surveillance country (PAVS) in Peru?

Yes. Peru's pharmaceutical registration rules list the United States among the High Sanitary Surveillance Countries, as confirmed in Supreme Decree DS 018-2019-SA. Peru also accepts GMP certificates from PAVS authorities.

Who regulates health products in Peru?

DIGEMID for medicines, medical devices and cosmetics, and DIGESA for food. Supplements fall under one or the other depending on how they are classified.

Does my FDA certificate need a Spanish translation?

Usually yes. Peruvian authorities generally expect foreign documents with a Spanish translation. Translate after the apostille is attached.

Which FDA certificate do I need for Peru?

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 products. Products not sold in the U.S. need a Certificate of Exportability.

How long does an FDA apostille for Peru 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 Peru

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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