Medical device registration-Bangladesh
Medical equipment registration-Bangladesh
Authorized representative is required for holding the medical device and medical equipment registration in Bangladesh.
Govt. fees for medical device import registration in Bangladesh:
Cost for medical device registration in Bangladesh is BDT 63,250 per product.
Cost for Class A medical device registration in Bangladesh is BDT 0 per product.
Required documents for medical device registration in Bangladesh for import:
- Legal agreement (copy) between the manufacturer & the local agent/distributor (and, Letter of authorization).
- EU MDR Certificate/CE marking/EC Design examination Certificate-pdf copy.
- FSC (Free Sale Certificate) of Manufacturing country-Bangladesh Embassy attested. Original
- FSC from any one of the following countries: EU country, USA, Germany, Switzerland, Japan, Australia, UK – Bangladesh Embassy attested (This is required for Class-C & Class-D Med. device) – Original
- Details regarding recall history of past 2 years (duly signed on letter head pad of the manufacturer).
- List of Countries where the product is being marketed. (duly signed on letter head pad of the manufacturer).
- Packaging Materials (empty): Box, Label, IFU, Labeling must reflect the Brand & Manufacturer name, Country of Origin, Mfg. date, Expiry date, Lot no.
- Colour Catalogue.
- Annexure-3 (will be prepared by Pharma DRA, a prescribed form by DGDA).
Class A medical device declaration prior to import into Bangladesh:
- Agency agreement between the manufacturer & the local agent.
- Letter of Authorization.
- FSC (Free Sale Certificate) of Manufacturing country -Bangladesh Embassy attested.
- EU Declaration of Conformity-pdf copy.
- Product catalogue.
- Product sample-1pc (for uncommon products only)
- No Govt. fees required.
Documents required for registration transfer/Local agent change:
- Letter of Authorization-signed by the manufacturer
- Legal agreement on 300 Taka stamp between the current registration holder & the new reg. holder.
- Original registration certificates.
- NOL (No objection Letter) from the current registration holder/local agent.
- Duplicate certificate issue fee BDT 500 + BDT 75 per registration certificate.
Registration renewal-every 5 years:
- LOA & Agency agreement.
- EC Certificate-pdf copy (Online verifiable).
- FSC (Free Sale Certificate) of Manufacturing country-Bangladesh Embassy attested. Original
- FSC of any EU country/USA/Germany/Switzerland/Japan
/Australia/UK-Bangladesh Embassy attested-Original (This is required for Class-C & Class-D Med. device). - Details regarding recall history of past 2 years (duly signed on letter head pad of the manufacturer).
- Original empty Box/Label
- Original Registration certificate
- MRP (Price) certificate is any
- Warehouse license copy
- Govt. fees USD 137/product (Equivalent to BDT 11500/product)
