Legislation Overview
DGDA · Drug and Cosmetics Act 2023 · GHTF · BD-Unique features
Primary Legislation — Drug and Cosmetics Act, 2023
Overview
The Drug and Cosmetics Act, 2023 (Act No. [X] of 2023, effective 18 September 2023) is the cornerstone of Bangladesh's regulatory framework for medical devices. It is the most significant legislative reform to Bangladesh's pharmaceutical and device regulation in more than 80 years.
Key Provisions
| Provision | Detail |
|---|---|
| Device definition | Instruments, apparatus, software, materials with a medical purpose — software explicitly included |
| Software classification | Software is categorised as a "Drug" under the Act — BD-Unique |
| Class-based registration | Class A (no registration) · Class B/C/D (mandatory, 5-year validity) |
| Local entity requirement | All registrations must be held by a Bangladesh entity (the AR) |
| Enforcement | Drug Court prosecution for serious violations |
| Pricing | DGDA retains price-fixing authority |
| Post-market obligations | Vigilance, recall, complaint handling obligations explicitly recognised |
Software Included as "Drug" — BD-Unique Implication
The classification of software as a "Drug" under the 2023 Act means that software developers must engage with the DGDA's drug/device registration processes. This is a legally significant categorisation — Bangladesh is one of a small number of markets that explicitly places software in the pharmaceutical regulatory category rather than creating a separate SaMD pathway.
Transition from Drugs Act, 1940
The Drugs Act, 1940 was the predecessor legislation. Under the transition framework:
- Devices registered under the 1940 Act framework may continue to circulate during a transition period while new registrations under the 2023 Act are pursued
- Manufacturers operating under the old framework should file new registration applications under the 2023 Act as a priority to ensure continued market access
Subordinate Legislation and Guidelines
DGDA Registration Guidelines for Medical Devices
The operational heart of device registration in Bangladesh. This document provides:
- Annexure 1 — Classification Rules: The GHTF-based Class A/B/C/D classification framework with detailed rules for each class
- Documentation requirements: Exact list of documents required per class
- Application procedures: How to submit, what forms to use, where to send
- Transitional provisions: How legacy registrations are handled
Drug Rules, 1946
Certain provisions of the Drug Rules, 1946 (issued under the Drugs Act, 1940) remain in effect pending the issuance of comprehensive new Rules under the 2023 Act. Manufacturers should confirm with the DGDA which specific provisions of the 1946 Rules continue to apply.
GHTF Guidance Documents Adopted by DGDA
The DGDA has adopted the following key GHTF documents as the basis for its registration requirements:
| GHTF Document | Relevance |
|---|---|
| GHTF/SG1/N055 — Role of Standards | How standards are used to demonstrate conformity |
| GHTF/SG1/N78 — Essential Principles | The safety and performance principles devices must meet |
| GHTF/SG2/N54 — Quality Management System | Framework basis for ISO 13485 recognition |
| GHTF/SG3 — Post-Market Surveillance | Vigilance and adverse event reporting framework |
| GHTF/SG4 — Auditing | Quality system audit principles |
| GHTF/SG5 — Clinical Evidence | Framework for clinical evaluation of medical devices |
International Standards Recognised by DGDA
| Standard | Use in DGDA Submissions |
|---|---|
| ISO 13485:2016 | QMS — mandatory for Class B/C/D; must cover relevant product category |
| ISO 14971:2019 | Risk management — required for all registered devices |
| ISO 10993 series | Biological evaluation of materials in contact with the body |
| IEC 62304 | Software lifecycle (for medical device software/SaMD) |
| IEC 62366-1 | Usability engineering |
| ISO 11135 / 11137 / 17665 | Sterilisation standards where applicable |
| IEC 60601-1 | Medical electrical equipment — general safety |
How to Navigate Bangladesh Legislation
- The Drug and Cosmetics Act 2023 is available from the Bangladesh National Parliament website and the Ministry of Health
- DGDA Registration Guidelines are available from the DGDA official website: www.dgda.gov.bd
- Gazette notifications containing new regulations are published by the Ministry of Health & Family Welfare
- Monitor the DGDA website for new circulars and updated guidelines
The 2023 Act is new legislation — implementing rules, notifications, and interpretive guidance are still being developed. Check the DGDA website and consult your AR regularly for the latest developments.