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Bangladesh

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Regulatory

Bangladesh DGDA Medical Device Registration Guide: Classification, Import Permits, and Local Representative Requirements

Complete guide to registering medical devices in Bangladesh through the Directorate General of Drug Administration (DGDA) — four-tier risk classification (A–D) aligned with ASEAN MDD, two-step Recipe Approval and Final Registration process, reference country Free Sale Certificate requirements, local authorized representative obligations, import licensing and indent approval workflow, Maximum Retail Price (MRP), Bengali labeling, ISO 13485 QMS expectations, Drug and Cosmetics Act 2023, fees, timelines, and South Asia market strategy.

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