Recent Regulatory Changes
DGDA · 2023–2026 developments
2023 — Major Legislative Reform
Drug and Cosmetics Act, 2023 — Effective 18 September 2023
Bangladesh's most significant regulatory reform in over 80 years came into force on 18 September 2023. The key changes affecting medical device manufacturers:
1. Software explicitly included as a medical device Software with a medical intended purpose is now explicitly regulated as a medical device, categorised as a "Drug" under the Act. Software developers must assess whether their products require DGDA registration.
2. Formalised Class A–D registration framework The 2023 Act codifies the class-based registration system — Class A (no registration required), Class B/C/D (mandatory, 5-year validity) — providing a clearer statutory basis for the existing GHTF-aligned framework.
3. Strengthened enforcement provisions The Drug Court mechanism is strengthened, with enhanced penalties for serious violations including supply of unregistered Class B/C/D devices, falsification of documents, and non-compliance with recall orders.
4. Price-fixing authority retained The DGDA retains its authority to fix prices for registered medical devices. This provision remains in force under the 2023 Act.
5. Local entity requirement codified The requirement for a Bangladesh-registered AR to hold all device registrations is now explicitly legislated, removing ambiguity about the previous administrative requirement.
Drug and Cosmetics Act 2023 — Implementation Tracker
| Implementation Element | Status | Notes |
|---|---|---|
| Act in force | ✅ Effective 18 Sep 2023 | |
| New registration application forms | ✅ Available from DGDA | |
| Classification guidelines (Annexure 1) | ✅ Available | |
| New Rules under 2023 Act (replacing Drug Rules 1946) | ⏳ Pending | Draft expected; monitor DGDA website |
| Price-fixing regulations update | ⏳ Pending | Confirm current status with DGDA |
| Software-specific guidelines | ⏳ Pending | Await DGDA guidance on SaMD specifics |
DGDA Quarterly Review Schedule
The DGDA conducts completeness reviews of submitted registration applications quarterly. The schedule for 2026 quarterly review windows:
| Quarter | Approximate Review Window |
|---|---|
| Q1 2026 | January–March 2026 |
| Q2 2026 | April–June 2026 |
| Q3 2026 | July–September 2026 |
| Q4 2026 | October–December 2026 |
Confirm exact review dates directly with the DGDA — the specific dates within each quarter are set by the DGDA. Submit your dossier 2–4 weeks before the review window for best results.
Upcoming Changes & Reform Outlook
| Expected Development | Status | Watch |
|---|---|---|
| New Drug Rules under 2023 Act | Draft in preparation | Ministry of Health gazette |
| SaMD-specific guidelines | Under development | DGDA website |
| Potential UDI system introduction | Under consideration | IMDRF Bangladesh engagement |
| ASEAN harmonisation deepening | Ongoing discussions | Ministry of Health |
Monitoring DGDA Updates
Stay current with Bangladesh regulatory developments through:
- DGDA website: www.dgda.gov.bd — check for circulars, guideline updates, and new forms
- Ministry of Health & Family Welfare: mohfw.gov.bd — gazette notifications
- Bangladesh Government Gazette: For official legislative changes
- Your AR: Your Bangladesh AR should be monitoring DGDA announcements as part of their service
If you have devices registered under the legacy Drugs Act 1940 framework, confirm with your AR whether a re-registration under the 2023 Act framework is required and plan accordingly.