Mandatory Problem Reporting Form
Please download the “Mandatory Problem Reporting Form” on below link. Mandatory Problem Reporting Form.pdf
Read moreCosmetic & Medical Device
Declaration of Product Safety Format ပုံစံ
Please download the “Declaration of Product Safety Format” on below link. Declaration-of-Product-Safety-Format
Read moreClass C and Class D Medical Device များ တင်သွင်းခွင့် ထောက်ခံချက် လျှောက်ထားရာတွင် လိုအပ်သော စာရွက်စာတမ်းများ
Cover Letter Letter of authorization from owner or manufacturer Product description Manufacturing license or GMP certificate copy/ EC certificate ISO
Read moreClass B ( Low-Medium Risk ) Medical Device များ တင်သွင်းခွင့် ထောက်ခံချက် လျှောက်ထားရာတွင် လိုအပ်သော စာရွက်စာတမ်းများ
Cover Letter Letter of Authorization from owner or manufacturer Product Description (If necessary) Manufacturing License/ GMP Certificate/ EC certificate ISO
Read moreClass A ( Low Risk ) Medical Device များ တင်သွင်းခွင့် ထောက်ခံချက် လျှောက်ထားရာတွင်လိုအပ်သော စာရွက်စာတမ်းများ
Cover Letter Letter of Authorization from owner or manufacturer Product Description (If necessary) Manufacturing License or GMP Certificate Copy ISO
Read moreLOA Format
Download “LOA format”
Read moreTEMPLATE FOR DECLARATION OF CONFORMITY
Download “TEMPLATE FOR DECLARATION OF CONFORMITY”
Read moreASEAN Medical Device Directive(AMDD)
Link of ASEAN Medical Device Directive(AMDD) https://asean.org/storage/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
Read moreNotification of Cosmetic Product Application
A Guideline on Notification of Cosmetic Product Application, issued in February 2009. Download
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