The two-step Recipe Approval
Primary Review (3–4 months) earns the Recipe Approval letter — then final registration (30–40 days) with embassy-attested originals.
Free field guide · PDF
Bangladesh DGDA Medical Device Registration2026 Field Guide
The two-step Recipe Approval, the reference-country gate, and the one-holder rule — with local labeling duties.
- Two-step timeline
- 4–6 mo
- Government fee
- ~$600
- Certificate validity
- 5 yrs
Sourced from DGDA guidance and verified 2026 publications.
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Every figure in this guide traces to a named source — DGDA guidance and verified 2026 publications.
The reference-country gate
Class C/D needs an EC Certificate from a reference country — and ISO 13485 is required for all Class B, C, and D devices.
The one-holder rule
Only one License Holder per device — with post-customs local labeling carrying the BDT Maximum Retail Price.
Sources & scope
- elendilabs.com, Bangladesh Medical Device Registration: DGDA Approval Process.
- asiaactual.com, Bangladesh Launches New Medical Device Regulations.
- indexbox.io, Bangladesh X-ray apparatus market report 2026.
This guide is market-access intelligence, not regulatory or legal advice. DGDA timelines, fees, and review practice change — professional review is required before business use.
Market Access Strategy Session
Bangladesh on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your DGDA route — holder selection, Recipe Approval sequencing, and embassy-attested document planning.
Professional review is required before business use.
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