Medical Device Labeling Requirements in Bangladesh

Medical device labeling is part of the regulatory review for market entry in Bangladesh. Manufacturers should review labels, packaging and instructions for use before submission so that the information presented to DGDA is consistent with the product dossier and supporting certificates.

What should be checked on the label?

The required information depends on the device, but the label should clearly identify the product and manufacturer and provide the information necessary for safe identification and use. Relevant details may include the device or brand name, model or catalogue reference, manufacturer information, country of origin, lot or serial identification, manufacturing and expiry information where applicable, storage conditions, warnings and other product-specific information.

Label, packaging and IFU must agree

A common regulatory issue is inconsistency between the label and other submission documents. Product names, model numbers and manufacturer details should be aligned across the label, outer packaging, instructions for use, catalogue, Free Sale Certificate and other regulatory evidence.

If multiple models are submitted together, the dossier should make it clear which labeling belongs to each model or family. Changes made only for the Bangladesh market should also be controlled so they do not create a conflict with the manufacturer’s approved product information.

Do not treat labeling as a final-stage task

Labeling should be reviewed during dossier preparation, not after registration work has already started. If DGDA identifies unclear manufacturer information, inconsistent models or missing safety information, clarification or revised artwork may be required.

Manufacturers should also consider whether the device needs particular symbols, handling instructions, sterile information, single-use identification or other statements based on its characteristics. The applicable requirement should be confirmed against the current DGDA guideline and product-specific checklist.

MedTech can review draft labels, packaging and IFU together with the registration dossier to identify inconsistencies before submission in Bangladesh.