DGDA DOCUMENT CHECKLIST

Documents Required for Medical Device Registration in Bangladesh

The key documents foreign manufacturers commonly need when preparing a Bangladesh medical device registration application.

Core registration documents

Letter of Authorization and agreement with the local agent or registration holder.
Applicable CE/EU regulatory certificate or conformity evidence.
Free Sale Certificate from the manufacturing country with required attestation.
Additional reference-country FSC where applicable for Class C and D products.
Recent recall-history declaration and list of countries where the product is marketed.
Product packaging, label/IFU and colour catalogue.
Declaration of Conformity where applicable.

Practical tip: Review document validity, manufacturer names and product model details across every certificate before submission.

Requirements vary by product

The exact dossier can differ according to device class and product type. A pre-submission document review helps identify missing certificates, labeling issues and attestation requirements early.

Need support with your Bangladesh registration?

MedTech supports manufacturers with regulatory documentation, registration and Bangladesh market access. Requirements may change, so confirm the current DGDA requirements for your specific product before submission.