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FDA Apostille for Chile

FDA Certificates · Chile

FDA Apostille for Chile

Chile has applied the Hague Apostille Convention since 30 August 2016. Before that, U.S. documents needed Chilean consular legalization. Now an FDA export certificate needs one U.S. Department of State apostille for a file in Santiago. Upload the digital certificate and we return it apostilled by FedEx.

  • Hague membersince 30 August 2016
  • 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 Chile Asks for an Apostilled FDA Certificate

Chile's Public Health Institute (ISP) registers medicines, cosmetics and the medical devices subject to sanitary control. Food and supplements are overseen by the Ministry of Health through its regional health secretariats. Registration files for imported products rely on official documents from the country of origin, and for U.S. products those come from the FDA.

Chile also relies more and more on approvals from trusted regulators. Under ISP Resolution E679 of 2025, a biological medicine can follow a reliance route if it has been approved by at least two of five reference agencies: the U.S. FDA, the EMA, the UK MHRA, Australia's TGA and Japan's PMDA. Since the FDA is a federal agency, only the U.S. Department of State can apostille its certificates. We handle that and ship the result to you or your Chilean registration holder.

Which FDA Certificate Does Your Chilean Importer Need?

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

Product typeChilean authorityFDA certificate
Medicines & biologicalsPublic Health Institute of Chile (ISP)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesISP, for device types subject to mandatory sanitary controlCertificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaMinistry of Health, regional health secretariats (SEREMI de Salud)Certificate to a Foreign Government (CFG), Health Certificate
Food supplements & medical foodsMinistry of Health, under the Food Sanitary RegulationCertificate of Free Sale (CFS)
Cosmetics & personal carePublic Health Institute of Chile (ISP)Certificate for Cosmetics

In Chile, only certain device types need ISP registration, and food is controlled regionally under the national Food Sanitary Regulation. Your Chilean registration holder will confirm whether your product needs registration and which FDA certificate applies.

How the FDA Apostille for Chile Works

The Hague Apostille Convention has been in force for Chile since 30 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.

  1. Upload your FDA certificate

    Send the digital certificate exactly as the FDA issued it and choose Chile 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 Santiago or anywhere else.

Exporting to Chile: What to Prepare

Reliance for biologics

Since February 2025, biological medicines approved by at least two of the FDA, EMA, MHRA, TGA and PMDA can use ISP's reliance route. ISP checks admissibility within 10 business days, and with the reference agencies' evaluation reports it can focus its review on the summary module of the dossier. Approval documents from those agencies are central to the file.

Food labeling rules

Chile's food labeling law requires black front-of-pack warning labels on foods high in sugar, sodium, saturated fat or calories, and restricts how those foods are marketed. U.S. food and supplement exporters usually need Chile-specific packaging in addition to their apostilled certificates.

Spanish translation

Chilean authorities work in Spanish and generally expect foreign documents to be translated. Have the FDA certificate apostilled first and translated afterwards, so the translation also covers the apostille.

A Chilean registration holder

Sanitary registrations are held by a company established in Chile with a technical director. Make sure the manufacturer and product names on your FDA certificate match the holder's application.

FDA Apostille Cost for Chile

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 Chile: FAQs

Is Chile a member of the Hague Apostille Convention?

Yes. Chile joined by accession, and the Convention has applied there since 30 August 2016. A U.S. Department of State apostille is enough, so no Chilean consulate legalization is required.

Does Chile's ISP rely on U.S. FDA approval?

For biological medicines, yes. ISP Resolution E679 of 2025 created a reliance route for biologics approved by at least two of five reference agencies: the U.S. FDA, EMA, MHRA, TGA and PMDA. Other products follow ISP's standard procedures.

Do all medical devices need registration in Chile?

No. Only certain device types are subject to mandatory sanitary control by the ISP. Your Chilean registration holder can confirm whether your device is one of them.

Does my FDA certificate need a Spanish translation?

Usually yes. Chilean authorities generally expect foreign documents in Spanish. Translate after the apostille is attached so both are covered.

Which FDA certificate do I need for Chile?

A CPP for medicines and biologicals, a CFG for medical devices and conventional foods, a Certificate of Free Sale for food 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 Chile 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 Chile

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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