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Market Information

Myanmar’s healthcare expenditure per capita for 2020 was $72, a 17.92% increase from 2019.

Market Trend: Myanmar government officially announced that the nation-wide health insurance policies would go on sale for the first time under a one-year trial as of July 1, 2015.

Myanmar’s medical equipment market is expected to display an annual growth rate (CAGR 2023-2028) of 12.20%, resulting in a market volume of US$381.20m by 2028.


Myanmar has not enacted a Medical Device Act, which is required to be in accordance with the ASEAN Medical Device Directive (AMDD). Nonetheless, medical devices are currently regulated by the FDA of Myanmar, which falls under the purview of the Ministry of Health and Sports. The FDA began accepting applications for registration of medical devices since 2000, by issuing import notifications and import recommendations. Today, the FDA applies the AMDD standards when examining applications. Applications for registration of medical devices have to be filed at the FDA in the name of a local representative, usually the authorized distributor of a foreign manufacturer.

Market Info

Medical Device Regulation

Food & Drug Administration, under the MOH.

Classification, Fees, Timeline
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Product Registration Routes

Class A, B, C, D 

Useful Information

Validity of License: 5 years


License transfer: Change of Registration application needed.


Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.


နောက်ထပ်အသေးစိတ်အချက်အလက်များ လိုအပ်ပါသလား။

ကြှနျုပျတို့ကိုဆကျသှယျရနျ။ ကူညီရန် ကျွန်ုပ်တို့ ဤနေရာတွင် ရှိနေပါသည်။  ATTOPOLIS ပလပ်ဖောင်းတွင် ကျွန်ုပ်တို့ကို ဆက်သွယ်ပါ။

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