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Bangladesh

Medical Device Registration in 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.

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

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