Ministry of Health

Ministry of Health (Myanmar)

Regulatory Authority

Food and Drug Administration, Myanmar

Medical Device Regulation

ASEAN Medical Device Directive (AMDD)

Official Language

Burmese

Classification

Class A, B, C, D

Registration Process

• Determine the device classification
• Appoint an Authorized Representative.
• Prepare the technical documentation and submit to FDA
• Once approved, the medical device can be marketed in Myanmar

Documents Required

• Letter of authorization from a foreign manufacturer
• Free sale or export certificate from country of origin
• Manufacturing license or GMP certificate
• ISO certificate
• Manufacturing flow chart
• Certificate of analysis for product sample
• Business license/certificate of incorporation of local representative
• Technical Documents

Applicable QMS

ISO 13485

Authorized Representative

Yes

License Validity

5 years