Myanmar 

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