| Regulatory Authority | Food and Drug Administration |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | A,B,C,D |
| Medical Device Regulations | Guide for Medical Device | Click Here |
| Device Classification Guidelines |
According to ASEAN Medical Device Directive | Click Here |
| Registration Process | Medical Device Registration | Click Here |
| Requirement of Authorized Representative | YES |
| Language Requirement | Labels must be in Burmese and English Language |