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FDA Apostille for South Korea

FDA Certificates · South Korea

FDA Apostille for South Korea

South Korea has applied the Hague Apostille Convention since 14 July 2007. An FDA export certificate for an MFDS file or a Korean importer needs a single U.S. Department of State apostille, with no Korean consulate legalization. Upload the digital certificate and we return it apostilled by FedEx.

  • Hague membersince 14 July 2007
  • Apostilledocument route
  • Koreanofficial 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 →
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Why South Korea Asks for an Apostilled FDA Certificate

Korea's Ministry of Food and Drug Safety (MFDS) regulates medicines, medical devices, food, health functional foods and cosmetics in one ministry, and it is known for detailed, document-heavy reviews. Korean importers and their regulatory consultants routinely ask U.S. suppliers for official proof of a product's U.S. status, and an apostilled FDA certificate is the standard way to provide it.

U.S. exporters ship to Korea under the KORUS free trade agreement, which removed tariffs on many health and food products. Tariff-free access doesn't remove the paperwork, though. The FDA is a federal agency, so only the U.S. Department of State can apostille its certificates. We handle that step and ship the result to you or straight to your Korean importer.

Which FDA Certificate Does Your Korean Importer Need?

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

Product typeKorean authorityFDA certificate
MedicinesMinistry of Food and Drug Safety (MFDS)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesMFDS, notification or approval depending on risk classCertificate to a Foreign Government (CFG), Certificate of Exportability
Food, ingredients & infant formulaMFDS, under the Special Act on Imported Food Safety ManagementCertificate to a Foreign Government (CFG), Health Certificate
Health functional foodsMFDSCertificate of Free Sale (CFS)
Cosmetics & functional cosmeticsMFDSCertificate for Cosmetics

All of these categories sit with MFDS, but each follows its own procedure. Supplements, for example, are regulated as health functional foods, and functional cosmetics such as sunscreens or anti-wrinkle products need extra review. Your Korean importer will confirm which FDA certificate MFDS expects.

How the FDA Apostille for South Korea Works

The Hague Apostille Convention has been in force for South Korea since 14 July 2007, 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 South Korea 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 Seoul or anywhere else.

Exporting to South Korea: What to Prepare

Register the foreign food facility first

Under Korea's Special Act on Imported Food Safety Management, foreign facilities that make food, additives, health functional foods or food packaging for Korea must register with MFDS at least seven days before the first import declaration. Registration lasts two years. Unregistered facilities' products can be held at the port.

Korean translation

MFDS works in Korean, and importers often need Korean translations of foreign documents. Have the FDA certificate apostilled first, then translated, so the translation covers the apostille as well.

A Korean importer or license holder

Import approvals and declarations are filed by a Korean company, usually an importer or a license holder appointed by the manufacturer. Make sure the manufacturer and product names on the FDA certificate match its MFDS filings exactly.

Supplements are health functional foods

Products sold as dietary supplements in the U.S. are regulated in Korea as health functional foods, with their own ingredient and claims rules. Check early which ingredients and claims are allowed, alongside your apostilled Certificate of Free Sale.

FDA Apostille Cost for South Korea

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 South Korea: FAQs

Is South Korea a member of the Hague Apostille Convention?

Yes. South Korea joined by accession, and the Convention has applied there since 14 July 2007. A U.S. Department of State apostille is enough, so no Korean consulate legalization is required.

Who regulates FDA-type products in South Korea?

The Ministry of Food and Drug Safety (MFDS). It covers medicines, medical devices, food, health functional foods and cosmetics.

Do U.S. food facilities need to register with MFDS?

Yes. Under Korea's Special Act on Imported Food Safety Management, foreign facilities producing food, additives, health functional foods or food packaging for Korea must register with MFDS at least seven days before the first import declaration. Registration is valid for two years.

Does my FDA certificate need a Korean translation?

Often yes. MFDS works in Korean, and importers commonly need Korean translations. Translate after the apostille is attached so both are covered.

Which FDA certificate do I need for South Korea?

A CPP for medicines, a CFG for medical devices and conventional foods, a Certificate of Free Sale for health functional foods, 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 South Korea 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 South Korea

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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