Medical Device Registration Myanmar (ASEAN Group?)

[MD_Simy86]

Dear all,
I'm looking for some information regarding medical device registration in Myanmar.

I know that it is a member State of ASEAN but I have some doubts:
_ which is the Competent Authority?
_ despite Myanmar is in the ASEAN Group, is there a specific regulation for medical medical registration?

Thank you in advance for the availability and help,
see you

 

[rangani_rj]

Hi Simy86,

Myanmar is part of ASEAN and so accordingly they need to follow medical device guideline published by ASEAN, known as ASEAN Medical Device Directive (AMDD). Latest version is ?ASEAN Agreement on Medical Device Directive Version 14 Dated 26 Apr 2013?. AMDD will not be a law in itself, but member countries need to include in the national legislation by 2014. This guideline is similar to GHTF/EU directive. Though I am not sure whether they have implemented or not in their law and whether registration is required or not.

I mined the healthcare website but did not find any registration info. I found that Myanmar FDA is regulating MD but not sure about registration. Better you find out the telephone number of FDA or call local agent doing such type of registration.


Have a nice day

 

[MD_Simy86]

Hi rangani_rj,
thank you for the infomation provided here below!
Now it is more clear and I have some additional indications in order to analyze the registration in Myanmar!

See you and have a nice day!