Labelling Requirements
DGDA · Drug and Cosmetics Act 2023 · Labelling
Mandatory Label Contents
All medical devices registered with the DGDA must carry labelling meeting the following requirements:
| Element | Requirement |
|---|---|
| Device name | Trade name and/or generic name |
| Manufacturer name and address | Full legal name and registered address |
| AR name and address | Bangladesh AR's name and address as the local regulatory contact |
| Lot/batch number | For traceability to manufacturing batch |
| Manufacturing date | Date of manufacture |
| Expiry date | Where applicable (sterile devices, reagents, limited shelf-life items) |
| Intended purpose | Where not obvious from the device name |
| Warnings and precautions | Safety-critical information material to safe use |
| Storage and handling conditions | Temperature, humidity, light, etc. as applicable |
| Single-use symbol | ISO 7000-1051 symbol, where applicable |
| Sterility indication | Where applicable |
Language Requirements
English
All labelling for Class B, C, and D devices must be in English at minimum. English is acceptable for devices used exclusively by trained healthcare professionals.
Bengali (Bangla)
Devices intended for lay users or home use should include labelling and IFU in Bengali. This is strongly recommended and may be required for devices where the intended user population includes non-English-speaking patients.
Practical guidance: For devices sold through hospitals and used by clinicians, English-only labelling is generally acceptable. For devices sold through pharmacies or used directly by patients at home (e.g., blood glucose meters, pregnancy tests, home blood pressure monitors), Bengali labelling significantly improves patient safety and is expected.
Instructions for Use (IFU)
The IFU must:
- Accompany the device where the label alone cannot provide sufficient information for safe use
- Be written in clear, understandable language appropriate to the intended user
- Cover all necessary information for safe and effective use: intended purpose, indications, contraindications, warnings, adverse effects, performance characteristics, maintenance/calibration, disposal
- For home-use devices: be available in Bengali
Electronic IFU (eIFU): Contact the DGDA to confirm whether eIFU is currently accepted for specific device categories. Physical IFU is the standard expectation.
Promotional Claims
All promotional and advertising claims must be:
- Truthful and not misleading
- Consistent with the approved intended purpose in the DGDA registration
- Evidence-based — claims of performance must be supportable by the clinical/performance data in the dossier
Claims that exceed the approved intended purpose — e.g., claiming treatment of a condition not covered in the registration — are prohibited and may trigger enforcement action.
Labelling for Bangladesh Market
When adapting labelling for the Bangladesh market, ensure:
- AR name and address is added as the local regulatory contact
- Import information (import licence number where required) is correctly reflected
- Bengali translation is accurate and reviewed by a qualified medical translator
- The label version used in Bangladesh matches the version submitted to DGDA during registration
- Any post-registration labelling changes are notified to the DGDA before implementation