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FDA Embassy Legalization for Cambodia

FDA Certificates · Cambodia

FDA Embassy Legalization for Cambodia

Cambodia has not joined the Hague Apostille Convention, so FDA certificates for its Ministry of Health must be legalized rather than apostilled. We have the certificate authenticated by the U.S. Department of State and legalized by the Royal Embassy of Cambodia in Washington, then ship it by FedEx to you or your local partner in Phnom Penh in about 14 business days.

  • Not in Hagueembassy legalization needed
  • Two-step legalizationdocument route
  • Khmerofficial language
  • 14 daysstandard processing
FDA Digital Certificate Sample

Submit Your FDA Certificate for Cambodia

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 Cambodia fee$100 / Doc.
Total:$240 / Doc.

FedEx return shipping is available for completed documents after processing.

See expedited options →
Legalized FDA certificate sample

Why Cambodia Asks for a Legalized FDA Certificate

In Cambodia, imported medicines need both a product registration and an import visa from the Ministry of Health, a control system intended to govern the manufacture, import, export and sale of medicines. The work is handled by the Ministry's Department of Drugs and Food (DDF), which also registers medical devices under a four-class, risk-based framework set by Prakas No. 1258. Only a locally registered company can file with DDF, so foreign manufacturers appoint a Cambodian subsidiary or representative through a letter of authorization.

Food sits under a newer framework. Cambodia's Law on Food Safety, promulgated on 8 June 2022, makes the Ministry of Commerce the coordinator of enforcement with other ministries, and it requires importers to obtain an authorization certificate from the competent authority of the exporting country. For U.S. exporters of food, supplements and health products alike, an FDA certificate is that proof, and Cambodia expects it to be legalized by its embassy.

Which FDA Certificate Does Your Cambodian Importer Need?

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

Product typeCambodian authorityFDA certificate
MedicinesMinistry of Health, Department of Drugs and Food (DDF)Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesDDF, under Prakas No. 1258 (Classes A–D)Certificate to a Foreign Government (CFG), Certificate of Exportability
Food & ingredientsMinistry of Commerce (coordinating) with other ministries, under the 2022 Law on Food SafetyCertificate to a Foreign Government (CFG), Health Certificate
Dietary supplementsDDF or food authorities, depending on classificationCertificate of Free Sale (CFS)
CosmeticsDDF, ASEAN cosmetic notificationCertificate for Cosmetics

The Ministry of Health's DDF covers medicines, devices and cosmetics, while food safety is coordinated by the Ministry of Commerce. Your Cambodian partner will confirm which authority reviews your product and which FDA certificate it needs.

How FDA Embassy Legalization for Cambodia Works

Cambodia is not a party to the Hague Apostille Convention, so it does not accept apostilles. Your FDA certificate is first authenticated by the U.S. Department of State and then legalized by the Embassy of Cambodia.

  1. Upload your FDA certificate

    Send the digital certificate exactly as the FDA issued it and choose Cambodia 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 Cambodia for legalization, which takes about 5 business days.

  4. FedEx delivery

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

Exporting to Cambodia: What to Prepare

Committee timing drives approvals

DDF approves device registrations at committee meetings held every three to four months, and applications that miss a meeting roll over to the next. Overall device registration typically takes 12 to 18 months, so have legalized FDA certificates ready before you file.

Three-year device certificates

Cambodian device registrations are valid for three years and must be renewed with a new application. That's shorter than in many neighboring markets, so plan for more frequent document refreshes.

ASEAN dossier formats

Device files follow the ASEAN Common Submission Dossier Template (CSDT), and cosmetics follow ASEAN notification rules. Files prepared for Thailand, Vietnam or Malaysia can often be adapted, though each country still needs its own legalized certificates.

Import visas for medicines

Registered medicines also need an import visa before shipment. Keep your FDA certificates current, because an expired certificate can hold up both registration renewals and import approvals.

FDA Embassy Legalization Cost for Cambodia

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 Cambodia fee$100 / doc.Embassy legalization, about 5 business days. Paid by us on your behalf
Total$240/ doc.Standard processing: 14 business days. Expedited options available.

FDA Embassy Legalization for Cambodia: FAQs

Does Cambodia accept apostilles?

No. Cambodia is not a party to the Hague Apostille Convention. FDA certificates need U.S. Department of State authentication followed by legalization at the Royal Embassy of Cambodia.

How long does FDA legalization for Cambodia take?

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

How much does it cost?

$240per document: our $120 service fee, the $20 U.S. Department of State fee and the $100 Embassy of Cambodia fee.

Who regulates medicines and devices in Cambodia?

The Ministry of Health's Department of Drugs and Food (DDF). Medicines need registration and an import visa, and devices are registered in four risk classes.

Do I need a local partner in Cambodia?

Yes. Only a locally registered company can file with DDF, so foreign manufacturers appoint a Cambodian subsidiary or representative through a letter of authorization.

Which FDA certificate does Cambodia need?

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).

Nearby destinations

Get Your FDA Certificate Legalized for Cambodia

Upload your FDA certificate today and receive it legalized by FedEx in 14 business days, for $240per 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 Cambodia fee

Total:

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