DGDA Registration – Medicines & Medical Devices, Bangladesh

What exporters to Bangladesh need to know about DGDA: who needs it, products covered, the step-by-step process, documents and timelines.

Key facts

Key facts
AuthorityDirectorate General of Drug Administration (DGDA)
CountriesBangladesh
Mark—
RequirementMandatory
Typical timelineVaries – ask us
ValidityVaries – ask us
Local representativeYes – Bangladeshi local agent / importer

What is DGDA?

The Directorate General of Drug Administration (DGDA) regulates medicines and medical devices in Bangladesh. Imported products must be registered through a local agent before import, and the manufacturer's GMP status and product dossier are assessed.

Products covered

  • Medicines & APIs
  • Medical devices
  • Surgical consumables
  • Diagnostic kits

Examples only – coverage is set by the regulator’s current product list and HS codes. We confirm it for your product free of charge.

DGDA process step by step

  1. Appoint a Bangladeshi local agent / importer.
  2. Check whether an equivalent product is already produced locally, as this affects import registration.
  3. Prepare the dossier with GMP evidence, CoPP, specifications and labelling.
  4. Submit to DGDA and respond to evaluation queries.
  5. Obtain registration and import permission, then maintain renewals.

Documents required

  • Manufacturing licence and GMP certificate
  • Certificate of Pharmaceutical Product / free-sale certificate
  • Product dossier or device technical file
  • Labels and package inserts
  • Local agent authorisation

DGDA FAQs

Is DGDA mandatory in Bangladesh?

Yes – Imported medicines and medical devices must be registered with DGDA through a local agent before they can be imported and sold in Bangladesh.

Which products need DGDA?

Typical products include Medicines & APIs, Medical devices, Surgical consumables and Diagnostic kits. The official list changes over time, so we confirm coverage for your exact product and HS code in a free applicability check.

Does a foreign manufacturer need a local representative for DGDA?

Yes – Bangladeshi local agent / importer. PCN coordinates with your importer or arranges a representative where needed.

How long does DGDA take and how long is it valid?

Typical timeline: Varies – ask us. Validity: Varies – ask us. Share your product details and we will give you a realistic plan and cost.

Can every imported medicine be registered in Bangladesh?

Not always. Bangladesh has a large domestic pharma industry and import registration can depend on the product and local availability; we assess this before you invest in a dossier.

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Need DGDA for Bangladesh?

Send us your product details – we will confirm the requirement, documents, cost and timeline within 24 hours.