Medical Device Registration in
Myanmar
Ministry of Health
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