Who Needs to Comply?
DGDA · Drug and Cosmetics Act 2023 · Economic operator obligations
Overview
Bangladesh's regulatory framework places obligations on all entities in the medical device supply chain — manufacturers, importers, distributors, and the mandatory local Authorized Representative.
Foreign Manufacturers
Foreign manufacturers wishing to sell medical devices in Bangladesh cannot register directly with the DGDA. They must:
- Appoint a Bangladesh-registered Authorized Representative (AR) who will submit and hold the registration
- Provide all necessary documentation to the AR for dossier preparation
- Issue a valid Letter of Authorization naming the AR as their legal representative in Bangladesh
- Maintain manufacturing compliance — ISO 13485 certification is mandatory for Class B, C, and D devices
The manufacturer retains responsibility for the safety, quality, and performance of the device, while the AR holds accountability to the DGDA.
Authorized Representative (AR) — BD-Unique
The AR is a Bangladesh-registered company or individual who:
| Obligation | Detail |
|---|---|
| Holds the registration licence | The DGDA issues the registration to the AR, not the manufacturer |
| Submits the registration application | Only the AR can file with DGDA |
| Manages post-market obligations | Vigilance, FSCAs, recall coordination |
| Maintains import documentation | Works with importers on customs clearance |
| Maintains pricing compliance | Ensures product price aligns with DGDA-approved pricing |
| Answers to DGDA | Primary contact for all regulatory matters |
Important distinction: The AR does not need to be the entity physically importing the goods. A separate importer can handle the logistics while the AR holds the regulatory licence.
Local Manufacturers
Bangladesh-based manufacturers must:
- Obtain a DGDA manufacturing licence (separate from product registration)
- Comply with GMP requirements verified through DGDA factory inspection
- Register Class B, C, and D products before placing on the market
- Maintain ISO 13485 certification for Class B, C, and D products
Importers
Importers of registered medical devices must hold a DGDA import licence. This is a separate licence from the product registration and must also be in place for lawful commercial importation.
Distributors
Distributors operate through the registered AR/importer network. While distributors themselves may not require a separate licence for distribution activities, they must ensure they source devices from entities with valid DGDA registrations and import licences.
Lifecycle of a Medical Device in Bangladesh
| Stage | Action | Who |
|---|---|---|
| 1. Classify | Determine Class A/B/C/D | Manufacturer + AR |
| 2. Appoint AR | Bangladesh entity appointed | Manufacturer |
| 3. Obtain QMS cert | ISO 13485 (Class B/C/D) | Manufacturer |
| 4. Compile dossier | FSC, clinical evidence, risk management | AR + Manufacturer |
| 5. Submit to DGDA | Quarterly completeness review | AR |
| 6. Technical review | DGDA assesses the dossier | DGDA |
| 7. Registration issued | Validity: 5 years (B/C/D) | DGDA → AR |
| 8. Import licence | Separate application | AR/Importer |
| 9. Post-market | Vigilance, renewals, changes | AR |
Violations of the Drug and Cosmetics Act 2023 — including supply of unregistered devices, falsification of documents, or non-compliance with licensing requirements — are subject to prosecution in Drug Courts, a Bangladesh-specific enforcement mechanism with powers to impose significant penalties.