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.
DGDA at a Glance
| Authority | Directorate General of Drug Administration (DGDA) |
|---|---|
| Countries | Bangladesh |
| Mark | — |
| Requirement | Mandatory |
| Typical timeline | Varies – ask us |
| Validity | Varies – ask us |
| Local representative | Yes – Bangladeshi local agent / importer |
Products We Commonly Support
- Medicines & APIs
- Medical devices
- Surgical consumables
- Diagnostic kits
How Global Approbation Handles DGDA
- Step 1. Appoint a Bangladeshi local agent / importer.
- Step 2. Check whether an equivalent product is already produced locally, as this affects import registration.
- Step 3. Prepare the dossier with GMP evidence, CoPP, specifications and labelling.
- Step 4. Submit to DGDA and respond to evaluation queries.
- Step 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: Frequently Asked Questions
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. Coverage follows the regulator's current list and HS codes, so we confirm it for your exact product.
Does a foreign manufacturer need a local representative for DGDA?
Yes – Bangladeshi local agent / importer. Global Approbation 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 for 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.
Regulations, standards and deadlines change. Scope, testing route and timelines are confirmed product by product after our applicability review. Global Approbation is a consultancy and does not itself issue certificates; approvals are granted by the relevant authority, accredited laboratory or certification body.