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:
1. Legal agreement (copy) between the manufacturer & the local agent/distributor (and, Letter of authorization).
2. EU MDR Certificate/CE marking/EC Design examination Certificate-pdf copy.
3. FSC (Free Sale Certificate) of Manufacturing country-Bangladesh Embassy attested. Original
4. 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
5. Details regarding recall history of past 2 years (duly signed on letter head pad of the manufacturer).
6. List of Countries where the product is being marketed. (duly signed on letter head pad of the manufacturer).
7. Packaging Materials (empty): Box, Label, IFU, Labeling must reflect the Brand & Manufacturer name, Country of Origin, Mfg. date, Expiry date, Lot no.
8. Colour Catalogue.
9. Annexure-3 (will be prepared by Pharma DRA, a prescribed form by DGDA).
