Myanmar Product Registration & Certification
Important Notes
- FDA Mandatory Product Registration: All pharmaceuticals, medical devices, foods, cosmetics, and health products require registration and an import permit from the Food and Drug Administration.
- Nascent Regulatory Framework for Health Supplements: There is currently no highly refined independent regulation for modern dietary supplements. Such products are often managed under Food or related categories based on ingredients and claims.
- Local Authorized Agent/Importer System: A foreign manufacturer must appoint a locally registered Myanmar company as the agent/importer, responsible for submitting the registration and handling customs and regulatory matters.
- Myanmar Language Labeling & Document Translation: Key product label information must be in Myanmar language. Registration documents need to be in Myanmar or English, possibly requiring legalization.
- Price Control & Public Procurement Dominance: Prices of essential drugs are controlled. The market is primarily driven by MoH procurement, INGO projects, and military medical purchases.
- Emphasis on WHO Prequalification & Neighboring Country Approvals: The FDA, especially for essential medicines, places significant weight on WHO PQ and registration status in neighboring countries like Thailand and India.
Myanmar Specific Requirements
- Frontier Market in Transition with Intertwined Potential & Uncertainty: Political and economic reforms create opportunities amid huge healthcare needs, but weak infrastructure, forex controls, and a complex business environment pose challenges.
- Public System & International Aid Form Market Backbone: Procurement by the state health system and international aid constitutes the primary market for drugs and basic devices, with the private commercial segment still developing.
- Long-Term Coexistence of Traditional & Modern Medicine: Traditional medicine is widely used, and its regulatory relationship with modern healthcare is still evolving.
- Ongoing Regulatory Capacity Building: The FDA is working to strengthen its framework and enforcement, but process standardization, transparency, and predictability require further development, demanding patience and adaptability.
- ASEAN Member Engaging in Regional Harmonization: Myanmar is gradually aligning with ASEAN regulatory harmonization initiatives, though domestic implementation is relatively slow.
Medical Devices Registration
Regulatory Requirements
- Medical Device Import License
- Technical Documentation and Compliance Certificates
- Quality Management System Certification
- Burmese Language Labeling and Instructions
- Free Sale Certificate
- Certificate of Origin
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- FDA Review Submission
- Local Agent Appointment
- Import License Acquisition
Registration Timeline
8-20 months
Official Fees
MMK 1,000,000 - 50,000,000
Service Fees
$14,000 - $45,000
Regulatory System Overview
Myanmar FDA
Food and Drug Administration, Myanmar
Responsible for registration approval, quality supervision, and market regulation of medical devices, cosmetics, and traditional medicines. Serves as the primary health product regulatory authority in Myanmar.
MOH
Ministry of Health and Sports, Myanmar
Responsible for developing national health policies and regulatory frameworks, overseeing FDA operations
Customs
Myanmar Customs Department
Responsible for customs clearance and regulation of imported products
Medical Devices Registration Process
Product Classification Determination
Determine product category according to Myanmar medical device requirements
Technical Documentation Preparation
Prepare Burmese technical documentation, compliance certificates, etc.
Local Agent Appointment
Appoint authorized agent within Myanmar
FDA Application
Submit medical device import license application to Myanmar FDA
Product Review
Pass FDA technical review and approval
Cosmetics Registration
Regulatory Requirements
- Cosmetic Import License
- Ingredient Safety Assessment
- Burmese Language Labeling Requirements
- Good Manufacturing Practice
- Product Safety Certification
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Import License Application
- Labeling Review Preparation
- Market Access Completion
Registration Timeline
6-14 months
Official Fees
MMK 500,000 - 20,000,000
Service Fees
$9,000 - $25,000
Regulatory System Overview
Myanmar FDA
Food and Drug Administration, Myanmar
Responsible for registration approval, quality supervision, and market regulation of medical devices, cosmetics, and traditional medicines. Serves as the primary health product regulatory authority in Myanmar.
MOH
Ministry of Health and Sports, Myanmar
Responsible for developing national health policies and regulatory frameworks, overseeing FDA operations
Customs
Myanmar Customs Department
Responsible for customs clearance and regulation of imported products
Cosmetics Registration Process
Ingredient Compliance Assessment
Confirm ingredients comply with Myanmar cosmetic regulations
Safety Assessment Report
Prepare product safety assessment report
Import License Application
Submit cosmetic import license application to Myanmar FDA
Labeling Compliance
Ensure labeling meets Burmese language requirements
Local Agent Appointment
Appoint authorized agent within Myanmar
Traditional Medicines Registration
Regulatory Requirements
- Traditional Medicine Registration
- Ingredient Safety and Quality Evidence
- Burmese Language Labeling Requirements
- Good Manufacturing Practice
- Traditional Use Evidence
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- FDA Registration Submission
- Labeling Review Preparation
- Registration Certificate Acquisition
Registration Timeline
7-16 months
Official Fees
MMK 800,000 - 30,000,000
Service Fees
$11,000 - $30,000
Regulatory System Overview
Myanmar FDA
Food and Drug Administration, Myanmar
Responsible for registration approval, quality supervision, and market regulation of medical devices, cosmetics, and traditional medicines. Serves as the primary health product regulatory authority in Myanmar.
MOH
Ministry of Health and Sports, Myanmar
Responsible for developing national health policies and regulatory frameworks, overseeing FDA operations
Customs
Myanmar Customs Department
Responsible for customs clearance and regulation of imported products
Traditional Medicines Registration Process
Product Classification Determination
Determine if product falls under traditional medicine category
Technical Documentation Preparation
Prepare ingredient analysis, traditional use evidence in Burmese
FDA Registration
Submit traditional medicine registration application to Myanmar FDA
Labeling Review
Ensure labeling complies with traditional medicine labeling requirements
Traditional Evidence
Provide evidence of traditional product usage