Medical Device Registration in
Ministry of Health:
Ministry of Health and Family Welfare
Directorate General of Drug Administration (DGDA)
Medical Device Regulation:
National Drug Policy 2016
Class A, B, C and D
- 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.
- 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
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
Class A – 30 days
Other – Based on DGDA