Overview
Myanmar’s Food and Drug Administration (“FDA“) operates an Inspection and Certification System aligned with Codex Alimentarius Commission (“Codex“) and Association of Southeast Asian Nations (“ASEAN“) standards, in line with the National Food Safety Policy. The FDA has now published updated Standard Operating Procedures (“SOP“) for obtaining Domestic Food Manufacturing Approval in January 2026. Since June 2022, domestic food businesses have been able to submit applications for Domestic Food Manufacturing Approval — both new applications and renewals — through the FDA’s E-Submission System at www.fda.gov.mm.
Who Must Apply?
| Category | Obligation | Legal Basis |
|---|---|---|
| Branded bottled drinking water producers | Mandatory — designated as “controlled food” | Order No. 524/2021 |
| Branded edible oil producers | Mandatory — designated as “controlled food” | Order No. 524/2021 |
| Other food enterprises | Voluntary — may apply where required by business needs | FDA SOP |
Key takeaway: If you produce branded bottled water or branded edible oil, approval is not optional. Other food businesses may still benefit from obtaining approval to satisfy commercial or contractual requirements.
How to Apply: The E-Submission Process
Applications must be submitted online via esubmission.fda.gov.mm, in accordance with the Applicant User Guide for Food Manufacturing Recommendation. Applicants must apply through the Regional or State FDA office that covers the location of their manufacturing factory.
Mandatory documents to submit:
- Artwork (product label or design)
- Step-by-step production process description (with a flow diagram where necessary; for renewals, photographic records of each production step are required)
- Quality control procedures
- Layout of factory land/premises, factory room layout, and factory location map
- Detailed product specifications
Optional supporting documents (submit if available):
- Trademark registration from the Intellectual Property (“IP“) Department
- International Organisation for Standardisation (“ISO“), Hazard Analysis and Critical Control Point (“HACCP“), Good Manufacturing Practices (“GMP“), or other food safety certificates
Assessment Process: What Happens After You Apply?
The assessment follows a risk-based approach. The core principles include risk-based and data-based assessment, prioritizing the development of domestic food businesses, and promoting responsibility and accountability.
Step 1 — Initial Screening
Once the application is submitted and the Document Assessment Fee is paid, it undergoes initial screening by the relevant Regional or State FDA office. If additional information is required, the FDA will notify the business by email and through the system. The business then has one month to resubmit; failure to do so will result in automatic cancellation (“Auto-Cancelled“) of the application.
Step 2 — Factory On-Site Inspection
A factory inspection is conducted only after the Pre-Inspection Fee is paid. If this fee is not paid within two weeks, the application is automatically cancelled.
During the inspection, businesses are assessed against the “Minimum Compliance Points for Food Businesses” and assigned a grade.
| Grade | Outcome |
|---|---|
| A or B | Proceed to risk profiling (High / Medium / Low). Full corrective actions must be submitted within the timeframe set by the Food Inspector. |
| C | Re-inspection required after submission of full corrective actions. |
| D | Food Inspector may propose refusal of the application. |
Step 3 — Approval and Certificate
Businesses graded A or B are categorized into High, Medium, or Low risk levels and, upon completion of assessment, are issued their Domestic Food Manufacturing Approval. The approval is valid for three years from the date of issuance. The approval certificate can be downloaded through the E-Submission System after paying the applicable Myanmar Kyat (“MMK”) product registration fees.
Ongoing Compliance: Post-Approval Sampling
After approval is granted, your business will be subject to ongoing product sampling based on your assigned risk level. Advance notice of sample submission requirements is sent by email and through the E-Submission System — once one month before the due date and again 15 days before.
Samples are selected per food sub-category using the General Standard for Food Additives (“GSFA“) Online Food Category grouping system.
| Risk Level | Sampling Schedule |
|---|---|
| High Risk | 4 times: at months 4, 12, 21, and 30 |
| Medium Risk | 3 times: at months 4, 17, and 30 |
| Low Risk | 2 times: at months 4 and 24 |
Sample quantities: For solid or powdered products — 1,000 grams; for liquid products — 3 litres per production batch.
Key Fees at a Glance
| Fee | Amount (MMK) |
|---|---|
| Document Assessment Fee | 50,000 |
| Factory On-Site Inspection Fee | 200,000 |
| Additional fee (GMP-compliant businesses) | 500,000 |
| Food Product Registration Fee | 20,000 per item |
| Laboratory Testing — First Test | 200,000 per item |
| Laboratory Testing — Second Test (microbiological / chemical) | 50,000 each |
Suspension and Revocation: What to Avoid
Non-compliance carries serious consequences. If samples are not submitted by the system-prescribed deadline, approval will be temporarily suspended, and the business will be publicly listed on the FDA website as a non-compliant entity. The suspended status will also appear publicly on the FDA’s E-Submission portal, shown as “Suspend” under the Certificate Status Validation Check.
Businesses whose approval is revoked must reapply as new applicants. Where products are classified as controlled foods, the FDA will conduct market surveillance inspections to check whether manufacturing, distribution, or sale is continuing.
What Your Business Should Do Now
- Check whether you are in scope — Branded bottled water and branded edible oil producers must apply. Other food businesses should assess whether voluntary registration would benefit their operations.
- Register on the E-Submission portal at esubmission.fda.gov.mm and familiarise yourself with the Applicant User Guide.
- Prepare your documentation — in particular, your product specifications, production process records, factory layouts, and quality control procedures.
- Budget for fees across the full approval lifecycle, including product registration and laboratory testing.
- Set calendar reminders for ongoing sample submission deadlines once approval is granted, to avoid suspension.
The information provided here is for information purposes only and is not intended to constitute legal advice. Legal advice should be obtained from qualified legal counsel for all specific situations.
DFDL maintains a premier Corporate and M&A practice across the ASEAN region. View our Myanmar location profile for details.
