Authority & regime
- Competent authority
- Directorate General of Drug Administration (DGDA, ঔষধ প্রশাসন অধিদপ্তর) under the Ministry of Health and Family Welfare is the regulator for drugs including medical devices; the existing de…

Research DGDA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Bangladesh medical device resource.
Search official DGDA device registration records.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official DGDA regulations and guidance documents.
Estimate the likely DGDA pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent DGDA policy, guidance, and compliance updates.
Describe your device and get a preliminary DGDA risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Bangladesh requirements.
Describe a device and find comparable products in the DGDA registration database.
The working-day service clocks DGDA's Citizen Charter publishes for device import registration, renewal and release.
The BDT amounts DGDA's Citizen Charter attaches to device import registration and renewal, and the treasury codes they are paid under.
Common questions about changing a registered medical device in Bangladesh. Each question separates published rules from details still awaiting verification.
23 of 25 research dimensions currently covered · 7 official sources · latest verification 2026-09-15
DGDA registration fees in BDT · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| Preliminary registration ("recipe") approval for import of a drug, medical device or IVD reagent | BDT 5,000 (BDT 5,750 with VAT) | Verified |
| Grant of import registration (registration and analysis fee) | BDT 50,000 (BDT 57,500 with VAT) | Verified |
| Renewal of import registration | BDT 10,000 (BDT 11,500 with VAT) | Verified |
Directorate General of Drug Administration (DGDA) review clocks and planning ranges · 4-class (A, B, C, D) classification
| Class / pathway | Review clock | Planning total | 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 DGDA publishes this clock per service, not per device class, so Class A through Class D all sit on the same 90-working-day stage | 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 Stages 1 and 2 run in sequence, so the charter-implied end-to-end clock for a first import registration is about 180 working days once the preliminary approval is in hand | 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 Item 30 adds a 5-working-day clock for the customs release certificate once the consignment has arrived | 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 |
Newest official DGDA headlines from the daily-refreshed feed — every row links directly to the authority publication.
Official DGDA rules and guidance · 8 of 8 documents linked to official sources
Computed from 4,422 official DGDA registration records · data as of 2026-08-22
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting Bangladesh work.
Connect the DGDA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against DGDA administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to DGDA evidence, notification, timing, and implementation questions.
Assess a current DGDA update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Bangladesh (DGDA).

