Medical Device Registration in

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

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

 

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