Food and Drug Administration, Myanmar

Food and Drug Administration, Myanmar

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Cosmetic & Medical Device

Cosmetic & Medical Device Database Guideline Medical Device 

Mandatory Problem Reporting Form

August 8, 2019August 9, 2019 admin 854 Comments

Please download the “Mandatory Problem Reporting Form” on below link. Mandatory Problem Reporting Form.pdf

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Cosmetic & Medical Device 

Declaration of Product Safety Format ပုံစံ

March 20, 2019 admin

Please download the “Declaration of Product Safety Format” on below link. Declaration-of-Product-Safety-Format

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Cosmetic & Medical Device 

Class C and Class D Medical Device များ တင်သွင်းခွင့် ထောက်ခံချက် လျှောက်ထားရာတွင် လိုအပ်သော စာရွက်စာတမ်းများ

March 20, 2019 admin

Cover Letter Letter of authorization from owner or manufacturer Product description Manufacturing license or GMP certificate copy/ EC certificate ISO

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Cosmetic & Medical Device 

Class B ( Low-Medium Risk ) Medical Device များ တင်သွင်းခွင့် ထောက်ခံချက် လျှောက်ထားရာတွင် လိုအပ်သော စာရွက်စာတမ်းများ

March 20, 2019 admin

Cover Letter Letter of Authorization from owner or manufacturer Product Description (If necessary) Manufacturing License/ GMP Certificate/ EC certificate ISO

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Cosmetic & Medical Device 

Class A ( Low Risk ) Medical Device များ တင်သွင်းခွင့် ထောက်ခံချက် လျှောက်ထားရာတွင်လိုအပ်သော စာရွက်စာတမ်းများ

March 20, 2019 admin

Cover Letter Letter of Authorization from owner or manufacturer Product Description (If necessary) Manufacturing License or GMP Certificate Copy ISO

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Cosmetic & Medical Device 

Parallel Import Template

December 18, 2018January 11, 2019 admin
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Cosmetic & Medical Device 

LOA Format

December 18, 2018January 11, 2019 admin

Download “LOA format”

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Cosmetic & Medical Device 

TEMPLATE FOR DECLARATION OF CONFORMITY

December 18, 2018January 11, 2019 admin

Download “TEMPLATE FOR DECLARATION OF CONFORMITY”

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Cosmetic & Medical Device 

ASEAN Medical Device Directive(AMDD)

December 18, 2018January 11, 2019 admin

Link of ASEAN Medical Device Directive(AMDD) https://asean.org/storage/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf

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Cosmetic & Medical Device Guideline 

Notification of Cosmetic Product Application

March 9, 2018 admin 14,638 Comments

A Guideline on Notification of Cosmetic Product Application, issued in February 2009. Download

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Contact Us

Department of Food and Drug Administration

Ministry of Health and Sports
Pyigyi Zayyar Road,(in front of Sabel Housing)
Zayyar Thiri Ward, Zabu Thiri Township,
Nay Pyi Taw, Myanmar.
Email : [email protected] , [email protected]
Phone : 067-403609

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