Myanmar Medical Device regulation

T

Tom Sha

Dear all,

Can any one provide the Myanmar Medical Device regulation? our products are PTCA catheters. Will they need registration before import and sales?

Thanks.:)
 
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T

Tom Sha

Dear Ronen,

Thank you very much for the link. It is helpful for me.
 

Murni Ahmad

Involved In Discussions
Dear All,

I am doing some search on the Medical Device Registration and importation of medical device in Myanmar.
So far i have found the following, please correct me if i`m wrong.
I also have some questions, appreciate if anyone can help to clarify or give some ideas. Thank you!

Health Authority of Myanmar website: Cosmetic & Medical Device Archives - Food and Drug Administration, Myanmar
  1. Stated in this website that this authority will control Food, Drug, Cosmetic and Medical Device.
  2. To date, no official regulation release for Medical Device, is this considered that medical device is not regulated?
    However, in the Database section, there is an announcement made in March 2018, on the list of exempted medical device- from Import Recommendation requirement.
  3. Can i assume that non-exempted medical devices must obtain an Import Recommendation (IR) from the Myanmar FDA? What are the requirements and the procedures?

Customs Authority link : Myanmar Customs
Seen some listed procedures, not much i can dig in since most documents are not in English.

Since the AMDD is expected to be harmonized accross ASEAN in 2020, have Myanmar made any announcement on the adoption of AMDD and enforcement date?

Appreciate any thoughts! Thank you.

Murni Ahmad
 
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