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FDA Embassy Legalization for Thailand

FDA Certificates · Thailand

FDA Embassy Legalization for Thailand

Thailand has joined the Hague Apostille Convention, but the Convention only takes effect there on 28 February 2027. Until then, FDA certificates for the Thai Food and Drug Administration still need U.S. Department of State authentication followed by legalization at the Royal Thai Embassy. We handle both steps and ship the document by FedEx in about 14 business days.

  • Apostille from 28 Feb 2027legalization until then
  • Two-step legalizationdocument route
  • Thaiofficial language
  • 14 daysstandard processing
FDA Digital Certificate Sample

Send Your FDA Certificate for Processing

Simply upload your FDA digital file, and you will receive your legalized document via FedEx.

Processing time 14 business days
  • We accept credit card payments.
  • Track your order history and expenses online.
  • U.S. Department of State and embassy fees are 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$120 / Doc.
US Dept. of State fee$20 / Doc.
Embassy of Thailand fee$15 / Doc.
Total:$155 / Doc.

The completed legalized document is returned by FedEx after processing.

See expedited options →
Legalized FDA certificate sample

Why Thailand Asks for a Legalized FDA Certificate

Thailand deposited its accession to the Apostille Convention on 30 June 2026, and HCCH lists 28 February 2027 as the date it enters into force. Existing member states have roughly six months from the deposit to object, a window that closes around the end of December 2026. Once the Convention applies, and provided the United States raises no objection, a single State Department apostille should replace embassy legalization. Thailand has named its Ministry of Foreign Affairs' Department of Consular Affairs as the authority for apostilles it issues.

Registration files don't wait for treaty dates, though. Thai FDA, part of the Ministry of Public Health, licenses imported medicines, medical devices, cosmetics, food and supplements, and many product renewals are coming due. Drug marketing authorizations granted after 13 October 2019 now expire after seven years, so the first renewals fall due from October 2026. If you need a Thai-ready FDA certificate before 28 February 2027, it still has to be legalized, and we arrange that for you.

Which FDA Certificate Does Your Thai Importer Need?

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

Product typeThai authorityFDA certificate
MedicinesThai Food and Drug Administration (Thai FDA), Ministry of Public HealthCertificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesThai FDA, under the Medical Device Act B.E. 2551 (2008), as amendedCertificate to a Foreign Government (CFG), Certificate of Exportability
Food & ingredientsThai FDA, under the Food ActCertificate to a Foreign Government (CFG), Health Certificate
Dietary supplementsThai FDA, food or drug route depending on composition and claimsCertificate of Free Sale (CFS)
CosmeticsThai FDA, ASEAN cosmetic notificationCertificate for Cosmetics

Thai FDA covers medicines, devices, food, supplements and cosmetics, each under its own act. Your Thai license holder will confirm which FDA certificate the file needs and whether it must be legalized or, after February 2027, apostilled.

How FDA Embassy Legalization for Thailand Works

Thailand has acceded to the Hague Apostille Convention, but it applies there only from 28 February 2027. Until that date, an apostille alone is not accepted, and FDA certificates follow the two-step route: U.S. Department of State authentication, then legalization by the Royal Thai Embassy in Washington.

  1. Upload your FDA certificate

    Send the digital certificate exactly as the FDA issued it and choose Thailand as the destination.

  2. State Department authentication

    We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.

  3. Embassy legalization

    We take the authenticated certificate to the Embassy of Thailand for legalization, which takes about 5 business days.

  4. FedEx delivery

    The legalized certificate ships to you, your importer or your agent in Bangkok or anywhere else.

Exporting to Thailand: What to Prepare

Seven-year drug licenses

Since the Drug Act amendment of 13 October 2019, new marketing authorizations expire after seven years. Renewals must be filed at least a year before expiry and meet current requirements, so the first wave of renewals is already underway.

Devices follow ASEAN rules

Medical devices are grouped into four ASEAN-aligned risk classes, and Class 2 to 4 files use the ASEAN Common Submission Dossier Template. FDA clearance supports an application but does not mean automatic approval, and product licenses are valid for five years.

A local license holder is required

Foreign manufacturers cannot register products directly. A Thai subsidiary, distributor or independent license holder with an establishment license files with Thai FDA and holds the registration.

Plan around 28 February 2027

For documents needed before the apostille takes effect, legalization is still the only route. For later filings, ask your license holder whether to wait for an apostille. We'll update our process as soon as the Convention applies.

FDA Embassy Legalization Cost for Thailand

ItemAmountNotes
Our service fee$120 / doc.Review, submission, tracking and FedEx dispatch
U.S. Department of State fee$20 / doc.State Department authentication, about 9 business days
Embassy of Thailand fee$15 / doc.Embassy legalization, about 5 business days. Paid by us on your behalf
Total$155/ doc.Standard processing: 14 business days. Expedited options available.

FDA Embassy Legalization for Thailand: FAQs

Does Thailand accept apostilles now?

Not yet. Thailand joined the Hague Apostille Convention on 30 June 2026, but it takes effect only on 28 February 2027. Until then, FDA certificates need State Department authentication and Royal Thai Embassy legalization.

What changes on 28 February 2027?

If no objection blocks it, U.S. public documents such as FDA certificates should need only a State Department apostille for Thailand, replacing embassy legalization. Certificates legalized before that date generally remain valid.

How long does FDA legalization for Thailand take?

About 14 business days: roughly 9 at the U.S. Department of State and 5 at the Royal Thai Embassy, followed by FedEx delivery.

How much does it cost?

$155per document: our $120 service fee, the $20 State Department fee and the $15 Embassy of Thailand fee, all included.

Who regulates health products in Thailand?

The Thai Food and Drug Administration, under the Ministry of Public Health. It licenses medicines, medical devices, food, supplements and cosmetics.

Which FDA certificate do I need for Thailand?

Usually a CPP for medicines, a CFG for devices and foods, a Certificate of Free Sale for supplements and a Certificate for Cosmetics for cosmetic products. Products not sold in the U.S. need a Certificate of Exportability.

Health Certificate

Collagen and gelatin exports (EU health certificate or SRM certificate).

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Get Your FDA Certificate Legalized for Thailand

Upload your FDA certificate today and receive it legalized by FedEx in 14 business days, for $155per document with State Department and embassy fees 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

14 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

Embassy of Thailand fee

Total:

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