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Bangladesh Medical Device Registration

Directorate General of Drug Administration (DGDA) approval timelines and requirements

2-5 months

Typical Timeline

Device Classes

MDSAP Accepted

Required

Bangladesh Local Agent

Bangladesh Medical Device Registration Overview

Bangladesh medical device registration through DGDA typically takes 2-5 months for Class A devices. The official DGDA target is 1-3 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Bangladesh uses a 4-class (A, B, C, D) risk-based classification system. Foreign manufacturers must appoint a Bangladesh Local Agent to register devices in Bangladesh. Registration is valid for 5 years.

Registration Timeline by Device Class

Bangladesh uses a 4-class (A, B, C, D) risk-based classification system.

Class A

Notification

Low Risk

Official

1-3 months

Realistic

2-5 months

• Simplified notification

Class B

Registration

Medium Risk

Official

3-6 months

Realistic

4-9 months

With Prior Approval

3-6 months

Accelerated with: FDA, EU CE Mark

• Technical documentation required

GMP/QMS Required

Class C

Registration

High Risk

Official

4-8 months

Realistic

6-12 months

With Prior Approval

4-8 months

Accelerated with: FDA, EU CE Mark

• Clinical data may be required

GMP/QMS Required

Class D

Full Registration

Highest Risk

Official

6-12 months

Realistic

9-18 months

With Prior Approval

6-12 months

Accelerated with: FDA PMA, EU CE Mark Class III

• Clinical evidence required

Clinical Trial RequiredGMP/QMS Required

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Bangladesh registration.

FDA 510(k)

Documentation support

2-3 months

EU CE Mark

Documentation support

2-3 months

Key Requirements

Bangladesh Local Agent
English/Bengali labeling
ISO 13485 certification
Free Sale Certificate
Technical documentation

Registration Validity:

5 years

Registration Process Flowchart

Bangladesh Medical Device Registration Process

Step-by-step DGDA registration process. Total estimated timeline: 2-5 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by DGDA. Appoint a Bangladesh Local Agent.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to DGDA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

DGDA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-3 months

In-depth technical assessment of device safety and performance. DGDA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, DGDA issues Bangladesh market authorization certificate.

Summary: The Bangladesh medical device registration process through Directorate General of Drug Administration (DGDA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

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Related Resources

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.