Ministry of Health and Sports, Union of Myanmar

Food and Drug Administration, Myanmar

Quality, Safety and Protection

  
FDA Myanmar Website is officially launched at 10:26 AM September 18, 2015.

Class B,C နှင့် D ဆေးပစ္စည်းများအတွက် ပူးတွဲတင်ပြရမည့် စာရွက်စာတမ်းများ

 

(၁)   Letter of Authorization from owner on manufacturer

(၂)    Manufacturing License or GMP Certificate copy

(၃)   ISO Certificate copy

(၄)   Certificate of Analysis for reference sample/ Declaration of conformity  

(၅)   Manufacturing flow chart

(၆)   Sterilization method for sterile products

(၇)   Free Sale or Export Certificate/ EC Certificate copy

(၈)   Copy of business license of the local company or certificate of   incorporation

 

 

 vNational Health Laboratory Recommendation is required for Rapid Diagnostic Test Kit.

 vClinical Evaluation Report is required for Class D Medical Devices.