Import Registration in Bangladesh
✅ Authorized Representative Requirement: it is a must.
Government Fees
- General Medical Device (Class B, C & D): BDT 63,250 per product.
- Class A Medical Device: BDT 0 (No fee).
Required Documents for Import registration (Medical device/IVDS)
- Legal Agreement between manufacturer & local agent/distributor + Letter of Authorization.
- EU MDR Certificate / CE Marking / EC Design Examination Certificate (PDF).
- Free Sale Certificate (FSC) from manufacturing country – Bangladesh Embassy attested (Original).
- FSC from one of the following countries (for Class C & D devices) – EU, USA, Germany, Switzerland, Japan, Australia, UK – Bangladesh Embassy attested (Original).
- Recall History of past 2 years – signed on manufacturer’s letterhead.
- List of Marketing Countries – signed on manufacturer’s letterhead.
- Packaging Materials (empty): Box, Label, IFU – must show brand, manufacturer, origin, Mfg. & Expiry dates, Lot no.
- Color Catalogue.
Class A Medical Device Declaration letter
- Agency agreement + Letter of Authorization.
- FSC from manufacturing country – Bangladesh Embassy attested.
- EU Declaration of Conformity (PDF).
- Product catalogue.
- Product sample (1 pc) – only for new category product.
Registration Transfer /Local agent change
- Letter of Authorization (signed by manufacturer).
- Legal agreement on BDT 300 stamp paper between current & new registration holder.
- Original registration certificates.
- No Objection Letter (NOL) from current registration holder/local agent.
- Duplicate certificate issue fee: BDT 500 + BDT 75 per certificate.
Registration Renewal-every 5 years:
- Letter of Authorization & Valid business agreement copy
- FSC – Country of Origin – Attested by Bangladesh embassy
- FSC – any EU country/Australia/Germany/USA/Japan/UK – Attested by Bangladesh embassy
- EC Certificate/EU MDR full quality management system – pdf
- Recall history – past 2 years – pdf
- List of exporting countries – pdf
- Empty box/Label – Original