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.

Documents Required:   

• Authorized Representative Agreement.
• Manufacturer Information.
• Product Dossier
• Notarised CoPP/FSC from Bangladesh Embassy
• Test protocol & Analytical certificate
• Packaging material information
• Registration Forms
• EC Certificate
• Declaration of Conformity/Conformity Assessment
• QMS certificates

Post-market Requirements:      

Adverse Events to be reported within 10 working days from the date of incident known to the to the manufacturer/importer

Legalized/Notarised Documents (if any)

FSC for Class C & Class D devices 

Applicable QMS:     

ISO 13485

Registration Timeline:     

Class A – 30 days

Other – Based on DGDA

Authorized Representative:     

Yes