Medical Device Regulatory Requirements in Myanmar

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
Language Requirement Labels must be in Burmese and English Language
Contact Phone 067-403609
Contact Email fdanpt1@gmail.com
Contact Address Ministry of Health Pyigyi Zayyar Road,(in front of Sabel Housing) Zaya Theidi Ward, Zabuthiri Township, Nay Pyi Taw, Myanmar.
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 09/Jul/2025

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