IVD reagents are classified as Class A, B, C and D in the medical device guideline of Bangladesh. DGDA is the regulatory authority for the IVD reagents and rapid test kits. Directorate General of Drug Administration (DGDA) is the licensing authority for Medical device, Pharmaceuticals, IVD reagents, rapid test kits, medical equipment and medicated cosmetics manufactured or sold in Bangladesh. Pharma DRA provides the regulatory intelligence service, gap analysis service, documents review and registration service for IVD reagents importation. Rapid test kits are also regulated by DGDA, hence registration of rapid test kits is mandatory. All these products regulation and control are under the jurisdiction of DGDA Bangladesh.
Timeline to get the registration certificate: 4 – 6 months.
Registration validity: 5 years
Govt. fees:
Class A: Not required.
Class B, C & D: BDT 63,250/product
Required documents for IVD instrument 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.
Class A IVD instrument/reagent 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 IVD 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 of IVD products issued by DGDA.
- NOL (No objection Letter) from the current registration holder/local agent.
- Duplicate certificate issue fee BDT 500 + BDT 75 per registration certificate.
