DGDA REGULATORY GUIDE

Medical Device Classification in Bangladesh: Class A, B, C & D

A quick guide to Bangladesh medical device risk classes and why correct classification matters before registration.

How medical devices are classified

Bangladesh uses a risk-based system with Class A, B, C and D. Class A represents lower-risk devices, while B, C and D represent progressively higher regulatory risk.

Key point: Confirm the product class before preparing the DGDA dossier. Classification affects documents, fees and the registration route.

Simple class examples

Class A: lower-risk products such as certain alcohol pads.
Class B: examples include blood pressure monitors.
Class C: examples include blood glucose monitoring systems.
Class D: highest-risk category; some bioprostheses fall in this class.

What manufacturers should do

Classification depends on intended use, device characteristics and applicable rules. Do not select a class only from a similar product name. Review the product information first, then prepare the registration package for that class.

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.