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FDA Apostille for Turkey

FDA Certificates · Turkey

FDA Apostille for Türkiye (Turkey)

Türkiye (Turkey) has applied the Hague Apostille Convention since 29 September 1985. An FDA export certificate for a TİTCK file or a Turkish distributor needs a single U.S. Department of State apostille, with no Turkish consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.

  • Hague membersince 29 September 1985
  • Apostilledocument route
  • Turkishofficial 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 Türkiye Asks for an Apostilled FDA Certificate

Türkiye's Medicines and Medical Devices Agency (TİTCK) licenses medicines and oversees medical devices and cosmetics, which are recorded in the national Product Tracking System (ÜTS). Food and food supplements fall under the Ministry of Agriculture and Forestry. Turkish importers, hospital buyers and regulatory consultants regularly ask U.S. suppliers for official proof of U.S. status, and an apostilled FDA certificate is the standard way to provide it.

Through its customs union with the EU, Türkiye largely follows EU-style rules for medical devices and cosmetics, so CE marking and EU documents often sit alongside the FDA certificate in a Turkish file. The FDA is a federal agency, so its certificates can only be apostilled by the U.S. Department of State. We handle that and ship the result to you or straight to your Turkish partner.

Which FDA Certificate Does Your Turkish Importer Need?

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

Product typeTurkish authorityFDA certificate
MedicinesTurkish Medicines and Medical Devices Agency (TİTCK)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesTİTCK, with registration in the Product Tracking System (ÜTS)Certificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaMinistry of Agriculture and ForestryCertificate to a Foreign Government (CFG), Health Certificate
Food supplementsMinistry of Agriculture and ForestryCertificate of Free Sale (CFS)
CosmeticsTİTCK, with product notification in ÜTSCertificate for Cosmetics

TİTCK covers medicines, devices and cosmetics, and the Ministry of Agriculture and Forestry covers food and supplements. Many device and cosmetic rules mirror the EU's, so your Turkish distributor will confirm which FDA certificate is needed alongside CE marking or other EU documents.

How the FDA Apostille for Türkiye Works

The Hague Apostille Convention has been in force for Türkiye since 29 September 1985, 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 Türkiye 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 Istanbul or anywhere else.

Exporting to Türkiye: What to Prepare

Sworn translation and notary

Turkish authorities work in Turkish, and foreign documents are usually translated by a sworn translator (yeminli tercüman), often with notarization. Apostille the FDA certificate first, then translate it, so the apostille is part of the certified translation.

Allow time for GMP checks

Medicine registrations in Türkiye can involve a separate TİTCK assessment of the foreign manufacturing site, which adds time. Have your apostilled FDA certificates ready early so they don't become a second delay.

ÜTS registration

Medical devices and cosmetics must be recorded in ÜTS, the national Product Tracking System, before they can be sold. The Turkish importer or distributor handles this, so make sure the manufacturer and product details on your FDA certificate match their ÜTS records.

Gateway to the region

Many Turkish distributors also supply the Caucasus, Central Asia and the Middle East. Georgia, Azerbaijan and Kazakhstan accept apostilles, while some Middle Eastern markets need embassy legalization. Tell us each destination.

FDA Apostille Cost for Türkiye

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 Türkiye: FAQs

Is Türkiye (Turkey) a member of the Hague Apostille Convention?

Yes. Türkiye ratified the Convention, and it has applied there since 29 September 1985. A U.S. Department of State apostille is enough, so no Turkish embassy or consulate legalization is needed.

Who regulates medicines and medical devices in Türkiye?

The Turkish Medicines and Medical Devices Agency (TİTCK). It also oversees cosmetics. Food and food supplements fall under the Ministry of Agriculture and Forestry.

Does my FDA certificate need a Turkish translation?

Usually yes. Turkish authorities generally require a translation by a sworn translator, often notarized. Translate after the apostille is attached.

What is ÜTS?

ÜTS is Türkiye's Product Tracking System. Medical devices and cosmetics must be registered in it before they can be placed on the Turkish market, usually by the local importer or distributor.

Which FDA certificate do I need for Türkiye?

A CPP for medicines, 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 Türkiye 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 Türkiye

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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