DGDA registration for imported medical devices: a short guide
· Site Administrator
Medical devices brought into Bangladesh fall under the Directorate General of Drug Administration. Registration is not optional for most clinical equipment, and hospitals increasingly ask for the registration number at tender stage.
What is usually required
- Manufacturer free-sale certificate or certificate of origin
- ISO 13485 certification for the manufacturing site
- CE, FDA or equivalent regulatory clearance
- Authorised-distributor agreement
- Technical file and instructions for use
Why it matters at purchase
Equipment supplied without valid registration can be held at customs, and government-tender participation generally requires the registration number on the offer. Ask any supplier for the DGDA number in writing before placing an order.
Every registered product in our catalogue lists its DGDA registration number on the product page.