Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Document Services
FDA Embassy Legalization for Myanmar
FDA Embassy Legalization for Myanmar
Myanmar (Burma) is not a party to the Hague Apostille Convention, so FDA certificates for its Department of Food and Drug Administration must be legalized. We have the certificate authenticated by the U.S. Department of State and legalized by the Embassy of Myanmar in Washington, then FedEx it to you or your local representative in about 15 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Burmese (Myanmar)official language
- 15 daysstandard processing
Start Your Myanmar FDA Document Processing
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 15 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 Myanmar fee$15 / Doc.
Total:$155 / Doc.
FedEx return shipping is available for completed documents.
See expedited options →Why Myanmar Asks for a Legalized FDA Certificate
Importing medicines into Myanmar is a three-stage process. A local representative first registers the product with the Department of Food and Drug Administration (DFDA) to obtain a Drug Registration Certificate. The importer then applies to DFDA for a Drug Importation Approval Certificate, which is valid for three years, and finally obtains an import license from the Ministry of Commerce's Department of Trade through its TradeNet 2.0 system. The legal basis is the National Drug Law of 1992, amended in 2014 and 2023.
Registration rules were updated by Notification No. 161/2023, in force since 1 January 2024. Applications now go through DFDA's e-submission system with online payment, imported registered drugs pay annual fees and are laboratory-tested by DFDA every five years, and renewals must be filed six months before expiry. A legalized FDA certificate gives your representative the proof of U.S. approval the registration file needs.
Which FDA Certificate Does Your Myanmar Importer Need?
Match your product to the Myanmar authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Myanmar authority | FDA certificate |
|---|---|---|
| Medicines | Department of Food and Drug Administration (DFDA), Ministry of Health | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | DFDA | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | DFDA, with Department of Trade import licensing | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | DFDA, as food or medicine depending on classification | Certificate of Free Sale (CFS) |
| Cosmetics | DFDA, ASEAN cosmetic notification | Certificate for Cosmetics |
DFDA registers medicines, devices, food and cosmetics, while the Department of Trade issues import licenses. Your Myanmar representative will confirm which certificate each file needs.
How FDA Embassy Legalization for Myanmar Works
Myanmar 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 Myanmar.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Myanmar as the destination.
State Department authentication
We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.
Embassy legalization
We take the authenticated certificate to the Embassy of Myanmar for legalization, which takes about 6 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Yangon or anywhere else.
Exporting to Myanmar: What to Prepare
Three approvals before shipping
A medicine needs a DFDA registration certificate, a DFDA importation approval and a Department of Trade import license. The importation approval can take around three months and the import license about 30 working days, so start early.
Foreign exchange rules for importers
Since 1 September 2024, Myanmar has granted pharmaceutical import licenses only after the importer submits proof of export earnings, and new applications need foreign exchange committee approval. Check that your importer can meet these conditions.
Annual fees and five-year testing
Under the 2024 rules, imported registered drugs pay annual fees online and are retested by DFDA every five years. Missing fees for two consecutive years blocks renewal, so stay on top of your registrations.
Check U.S. export rules
U.S. export controls and sanctions apply to certain end users in Myanmar. Screen your buyers and distributors before shipping, and take advice if you're unsure whether your product or customer is affected.
FDA Embassy Legalization Cost for Myanmar
| Item | Amount | Notes |
|---|---|---|
| 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 Myanmar fee | $15 / doc. | Embassy legalization, about 6 business days. Paid by us on your behalf |
| Total | $155/ doc. | Standard processing: 15 business days. Expedited options available. |
FDA Embassy Legalization for Myanmar: FAQs
Does Myanmar accept apostilles?
No. Myanmar (Burma) is not a party to the Hague Apostille Convention, so FDA certificates need U.S. Department of State authentication followed by legalization at the Embassy of Myanmar.
How long does FDA embassy legalization for Myanmar take?
About 15 business days: roughly 9 at the State Department and 6 at the Embassy of Myanmar, followed by FedEx delivery.
How much does it cost?
$155per document, made up of our $120 service fee, the $20 State Department fee and the $15 Embassy of Myanmar fee.
Who regulates medicines in Myanmar?
The Department of Food and Drug Administration (DFDA), which registers medicines and issues importation approvals under the National Drug Law.
Is Burma the same as Myanmar?
Yes. Burma and Myanmar are two names for the same country, and the same legalization route applies. Myanmar is not a member of the Apostille Convention.
Which FDA certificate does Myanmar need?
Myanmar files typically use 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.
FDA Certificates We Legalize for Myanmar
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Legalized for Myanmar
Upload your FDA certificate today and receive it legalized by FedEx in 15 business days, for $155per document with State Department and embassy fees included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
15 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 Myanmar fee
Total:
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