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In-Vitro Diagnostic (IVD) Reagent Registration in Bangladesh

The healthcare landscape of Bangladesh is evolving rapidly, driven by advancements in medical diagnostics and an increasing demand for quality healthcare solutions. Among the key components of modern diagnostics are In Vitro Diagnostic (IVD) reagents — critical tools that enable accurate detection, monitoring, and treatment of diseases. However, before these diagnostic reagents can enter the market, they must undergo a stringent and regulated registration process. Understanding this process is essential for manufacturers, distributors, and healthcare stakeholders seeking compliance and market access in Bangladesh.

In Bangladesh, the registration and regulation of IVD reagents fall under the jurisdiction of the Directorate General of Drug Administration (DGDA), the national regulatory authority responsible for ensuring the safety, quality, and efficacy of pharmaceuticals, medical devices, and diagnostic products.

The regulatory pathway for IVD reagents is designed to align with international best practices while catering to local public health needs. It ensures that only safe and effective products are made available to healthcare providers and patients across the country.

Required documents to register IVD reagents in Bangladesh:

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 required documents in Bangladesh:

  • 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.
 
Validity: For A declaration, there is no validity or no need to renewal. For other classes products, registration validity will be 5 years from the issue date and have to renewal after or before expired.