Bangladesh

Ministry of Health:

Ministry of Health and Family Welfare

Regulatory Authority:   

Directorate General of Drug Administration (DGDA)

Medical Device Regulation:      

National Drug Policy 2016

Official Language:           

Bengali

Classification:                  

Class A, B, C and D

Registration Process:    

• Determine the classification of the medical device.
• Appoint a local Authorized Representative.
• Class A = Declaration of Conformity only
• Class B, C & D
• Local Representative submits DoC or Registration application, along with the fees to DGD
• A technical committee reviews the registration application.
• If approved, the device is registered.
• Product marketing in Bangladesh can then begin.