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Medical Device Registration in Bangladesh

Medical device registration in Bangladesh is a mandatory regulatory requirement before importing, manufacturing, or marketing any medical device or IVD in the country. The process is regulated by the Directorate General of Drug Administration (DGDA) under the Ministry of Health and Family Welfare.

If you are a foreign manufacturer or local importer, understanding the regulatory pathway is essential to ensure smooth market entry and compliance.

Device Classification in Bangladesh

DGDA generally classifies medical devices based on risk category:

  • Class A – Low risk (e.g., surgical gloves)

  • Class B – Low to moderate risk

  • Class C – Moderate to high risk

  • Class D – High risk (e.g., implantable devices, life-supporting devices)

The classification determines the level of documentation and evaluation required.

Registration process:

Medical device registration involved in two steps.

Steps 01: Primary approval/Recipe approval. In this step, DGDA meeting is required. DGDA committee will evaluate the application and give decision for further process. It may approve or may reject. In this step, it may take 3-4 months’ time.

Step 02: Final registration. If the product is got primary approval, registration holder has to submit all required documents for getting primary approval. In this step, it may take 2-3 months.

Required Documents to register Medical device 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.
  9. Annexure-3 (will be prepared by MedTech, a prescribed form by DGDA).

Class A medical device declaration required documents in 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.

Medical device registration validity:

Medical device registration validity will be 5 years from the issue date.