Free Sale Certificate for Medical Device Registration in Bangladesh

A Free Sale Certificate (FSC) is an important regulatory document for many imported medical device submissions in Bangladesh. It helps demonstrate the product’s marketing status in the issuing jurisdiction, but simply having an FSC does not automatically mean it is suitable for a DGDA application.

What should manufacturers verify?

Before using an FSC in a Bangladesh submission, check that the manufacturer identity and product information are consistent with the rest of the dossier. The certificate should appropriately cover the device, models or product family being submitted. If the FSC uses a different manufacturer name, site address, brand or model description, the relationship may need to be clarified.

Country and authentication requirements

The exact FSC requirement can depend on the device class and current DGDA checklist. MedTech’s practical registration work has included FSC documentation from the manufacturing country and, for certain higher-risk submissions, regulatory evidence from recognized reference markets. Authentication or Bangladesh mission attestation may also apply to specific documents or submission routes.

Because document requirements can change, manufacturers should confirm the current requirement for their device before arranging legalization or attestation. This can prevent unnecessary cost and avoid preparing a certificate that does not meet the applicable submission requirement.

FSC is only one part of the dossier

DGDA’s medical device framework uses risk-based classification and requires appropriate conformity and registration evidence. An FSC should therefore be reviewed together with the Declaration of Conformity, quality or notified-body certificates where applicable, authorization documents, labeling and technical documentation.

Check validity and document scope early. Waiting until the final submission stage to identify an expired certificate or missing model can delay the registration process significantly.

MedTech assists overseas manufacturers in reviewing FSC suitability and identifying the supporting documents needed for medical device registration in Bangladesh before the dossier is submitted to DGDA.