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Registration Pathway Overview

DGDA · Drug and Cosmetics Act 2023 · BD-unique features highlighted

Registration Requirements by Class​

ClassRegistrationValidityAR RequiredISO 13485
A❌ Not required——Not required
B✅ Mandatory5 years✅ Yes✅ Required
C✅ Mandatory5 years✅ Yes✅ Required
D✅ Mandatory5 years✅ Yes✅ Required

BD-unique: Class A devices require no registration and have no expiry. They may be freely imported and distributed. Class B/C/D registrations expire after 5 years and must be renewed.

Mandatory Local Entity — Authorized Representative​

All DGDA registrations for foreign-manufactured devices must be held by a Bangladesh-registered Authorized Representative (AR). A foreign manufacturer cannot register directly with DGDA.

Who can be an AR?

  • Any Bangladesh-registered company with the technical and administrative capacity to fulfil AR obligations
  • Commonly the local distributor, a dedicated regulatory affairs company, or a locally registered subsidiary
  • The AR and the physical importer may be different entities

What does the AR do?

  • Submits the DGDA registration application
  • Holds the registration licence in their name
  • Corresponds with DGDA on all regulatory matters
  • Manages post-market obligations (vigilance, recalls, pricing compliance)

Registration Application Process​

Step 1: Appoint AR and Obtain Authorisation​

The manufacturer issues a Letter of Authorization to the AR, formally appointing them as the legal representative in Bangladesh.

Step 2: Compile the Registration Dossier​

The AR works with the manufacturer to prepare the dossier. For Class B/C/D this includes:

  • Completed DGDA application form
  • Letter of Authorization from manufacturer
  • ISO 13485 certificate (scope-appropriate)
  • Free Sale Certificate (FSC) from the country of manufacture
  • Device description and specifications
  • Risk management documentation (ISO 14971 summary)
  • Clinical/performance evaluation evidence
  • Labelling and IFU in English (and Bengali where applicable)
  • Manufacturing site information and GMP evidence

Full requirements per class: see Dossier Requirements.

Step 3: Submit to DGDA​

The AR submits the complete dossier to the DGDA central office.

Step 4: Quarterly Completeness Review — BD-Unique​

The DGDA reviews submitted applications for completeness on a quarterly basis, not continuously. This means:

  • Applications received in Q1 are reviewed at the Q1 completeness window
  • Applications received after a quarterly window must wait for the next quarter
  • Incomplete applications are returned with a deficiency list; the clock restarts

Strategic tip: Find out the DGDA's current quarterly review schedule before submitting. Submitting just before a quarterly review window maximises your chance of a prompt completeness check.

Step 5: Technical Review​

Applications that pass completeness review proceed to DGDA technical review, where evaluators assess the substantive technical content of the dossier.

Step 6: Registration Decision​

DGDA issues the registration certificate to the AR or rejects the application with reasons. The AR has an opportunity to respond to queries during technical review.

Timeline​

Average total timeline: 4–6 months from submission to registration decision — though this can vary depending on:

  • Whether the quarterly review window is close when you submit
  • Completeness of the dossier on first submission (incomplete dossiers reset the clock)
  • Complexity of the device (Class D takes longer than Class B)
  • DGDA workload at the time of submission

See Registration Timeline for detailed planning guidance.

Class A Devices — What to Do​

Class A devices do not require registration, but this does not mean unregulated supply:

  • The device must still meet essential principles of safety and performance
  • The manufacturer/AR should maintain technical documentation demonstrating compliance
  • Import licence may still be required for commercial importation
  • If a Class A device is later reclassified (e.g., through a change in intended purpose), registration becomes mandatory