Bangladesh medical device registration timeline
Source-linked clocksDirectorate General of Drug Administration (DGDA) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| All classes — stage 1, preliminary registration ("recipe") for import(DGDA preliminary registration approval) Citizen Charter item 24: approval of the preliminary registration ("recipe") for import of a drug, medical device or IVD reagent is 90 working days from receipt of a complete application, against a BDT 5,000 evaluation fee | 90 working days | 5-9 months | — | Verified |
| All classes — stage 2, grant of import registration(DGDA import registration) Citizen Charter item 25: grant of the import registration itself is a further 90 working days from receipt of a complete application, against a BDT 50,000 registration and analysis fee | 90 working days | 1-1.7 years | — | Verified |
| All classes — block import approval for a registered device(DGDA block import permission) Citizen Charter item 28: block approval to import a drug, medical device or IVD reagent from abroad is 40 working days and carries no fee | 40 working days | 2-4 months | — | Verified |
| All classes — renewal of import registration(DGDA registration renewal) Citizen Charter item 26: renewal of the import registration is 60 working days from receipt of a complete application, against a BDT 10,000 renewal fee | 60 working days | 3-6 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Bangladesh Medical Device Registration Process
Step-by-step DGDA registration process. Total estimated timeline: 5-9 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by DGDA. Appoint a Bangladesh Local Agent.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to DGDA including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksDGDA reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
90 working daysIn-depth technical assessment of device safety and performance. DGDA may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, DGDA issues Bangladesh market authorization certificate.
- Bangladesh Local Agent
- English/Bengali labeling
- ISO 13485 certification
- Free Sale Certificate
- Technical documentation
- The clocks come from the DGDA Citizen Charter service standard, not from the Drugs and Cosmetics Act 2023 or the Registration Guidelines 2015, neither of which puts a period on the authority
- The charter covers the import route only; a device manufactured in Bangladesh has no published registration clock
- Charter clocks all run from receipt of a complete application, so screening deficiencies restart the count in practice
- Related clocks: clinical trial protocol and CRO approval 45 working days (item 34); marketing authorisation 15 working days (item 13); vigilance reports within 10 working days; renewal applications up to 90 days before expiry
Reviewed 2026-08-30. End-to-end totals remain planning estimates.