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Bangladesh medical device registration resources

Research DGDA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Bangladesh medical device resource.

4,422 registration records10 free resources23/25 topics with records8 regulations trackedAug 2026 fees reviewed

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Structured regulatory requirements

Explore all 44 source-linked facts

23 of 25 research dimensions currently covered · 7 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
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…
1 source-linked fact
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Current device guidance
DGDA's Medical Device files page (last updated 4 March 2026 when checked) lists the 'Registration Guidelines for Medical Devices, Bangladesh 2015' and an imported device checklist.
Primary legislation
Primary legislation: ঔষধ ও কসমেটিকস্ আইন, ২০২৩ (Drugs and Cosmetics Act 2023, Act No. 29 of 2023), dated 18 September 2023 and effective immediately; in case of conflict between the Bangla…
3 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Devices regulated as drugs
The statutory definition of drug (ঔষধ) expressly includes medical device as clause (খ) of ধারা ২(৫), so medical devices are regulated under the drug regime of the Drugs and Cosmetics Act 20…
Medical device definition
Medical device (মেডিক্যাল ডিভাইস) means any instrument, apparatus, implement, machine, appliance, implant, diagnostic reagent (in vitro, in vivo and in silico reagent), software or similar…
2 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
Risk classes A through D.
Class A, Class B, Class C, Class D
1 maintained scheme
Checked 2026-08-25
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D05

Registration pathways

Verified
Class B/C/D registration scope
All medical devices of Class B, C and D must be registered with DGDA before they are imported or manufactured into Bangladesh; application must be made before first import/manufacture (and…
Registration and MAC requirement
No person or entity may manufacture, import, export, sell, distribute, stock or display any drug (including medical devices) without registration from the Licensing Authority (DGDA); before…
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
Import conditional on registration in listed countries
For import purposes the Licensing Authority will not grant registration or a licence for a drug (including a device) for human or animal use unless the product is registered under the same…
China NMPA approval: not reference
statement: For Class C and D devices the DGDA registration dossier must contain a free sale certificate from any one of the EU, USA, Canada, Australia and Japan in addition to the country o…
7 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Foreign manufacture under licence agreement
A foreign manufacturer that has concluded a licence agreement with a Bangladeshi drug manufacturing establishment may be permitted, subject to conditions imposed in the public interest, to…
Local authorized person/agent as applicant
The registration application must be made by a local authorized person of the manufacturer, or the foreign supplier, or an authorized agent, to DGDA; an authorisation letter in original fro…
2 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Establishment licence requirement
No person or entity may manufacture, sell, stock, distribute or display for sale any drug (including devices) without a licence from the Licensing Authority or beyond licence conditions; ma…
Import licence and prior approval
Import of any drug (including devices) is prohibited without a licence or beyond licence conditions, and no registered drug may be imported without prior approval of the Licensing Authority…
2 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Maximum 5 products per application
Similar device types manufactured at the same premises may be included in one application (e.g. all stents, all intra ocular lenses, all catheters), but an application may not cover more th…
Device Master File only without CE/FDA approval
A Device Master File (construction materials and quantitative analysis) is required only where CE or US FDA approvals are not available; where such approvals exist they serve as the primary…
3 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Prescribed application form and fee
Application for device registration is made in the prescribed form to the office of the DGDA by the authorized person or local authorized agent, with the prescribed fee paid along with the…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Labeling per ISO/GHTF standards
Device packaging must be labeled per relevant International/ISO standards and GHTF guidance GHTF/SG1/N70:2011, with internationally accepted symbols (e.g. sterilization, single use) per ISO…
1 source-linked fact
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Foreign manufacturer GMP inspection
When registering importable drugs (including devices), DGDA may, if needed, inspect the manufacturing premises of the foreign manufacturer for GMP verification; all inspection costs are pai…
Notified-body QMS certification for B/C/D
For Classes B, C and D (medium to high risk), certification by a notified body with regard to the QMS is required, and for Class D also certification for the design of the device; manufactu…
3 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
Medical electrical evidence
Electrical safety
BTRC radio equipment approval/enlistment
Wireless / radio
2 maintained overlays
Open details →
Preliminary registration ("recipe") approval for import of a drug, medical device or IVD reagent
BDT 5,000 (BDT 5,750 with VAT)
Grant of import registration (registration and analysis fee)
BDT 50,000 (BDT 57,500 with VAT)
3 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Unresolved
All classes — stage 1, preliminary registration ("recipe") for import · DGDA preliminary registration approval
90 working days
All classes — stage 2, grant of import registration · DGDA import registration
90 working days
All classes — block import approval for a registered device · DGDA block import permission
40 working days
4 maintained pathways
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Establishment licence validity
Establishment licences are valid for 2 years from the date of grant and are renewable; the renewal application must be submitted not more than 90 days before expiry.
Registration validity and renewal window
Drug (including device) registration remains valid for 5 years and is renewable; the renewal application must be submitted not more than 90 days before expiry; the Marketing Authorization C…
2 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Prior approval for new/expanded manufacturing
Without prior approval of the Licensing Authority, no new manufacturing project may be undertaken nor an ongoing project expanded.
Unauthorized premises change sanction
Changing the physical infrastructure of the licensed premises without prior approval of the Licensing Authority in a way that adversely affects or could affect product quality is a ground f…
2 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Public register of registered products
The Department (DGDA) must publish on its website the list of registered drugs with prescribed information and update it from time to time.
1 source-linked fact
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Approval for device trials
Pre clinical, clinical, field or performance trials and biocompatibility or bioequivalence studies on drugs, vaccines and medical devices are conducted by Contract Research Organizations; t…
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
Custom-made devices and exhibition samples
Custom made devices may be placed on the market if accompanied by a statement available to the particular identified patient or user; non conforming devices may be shown at trade fairs, exh…
Emergency registration
In sudden disaster, epidemic outbreak or national emergency need, a registration certificate may be granted without the prior recommendation of the Drug Control Committee, subject to prescr…
3 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
PMS for Class B/C/D
Once a Class B, C or D device is placed on the market in Bangladesh, the manufacturer or importer must adhere to post marketing surveillance requirements to systematically monitor the perfo…
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Vigilance reporting deadline
Serious adverse events must be analyzed and reported as vigilance reports to the designated authority in DGDA within 10 working days from the date the incident becomes known to the manufact…
Mandatory pharmacovigilance duty
Manufacturers, importers and marketing companies, hospitals, clinics, public health programme institutions and other stakeholders must mandatorily conduct pharmacovigilance activities for m…
2 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Immediate stop-sale on harmful reaction or death
If a harmful reaction appears in humans or animals from use of a registered drug (including devices), or a human or animal dies as part of such a reaction, the Licensing Authority may immed…
Withdrawal and destruction orders
Where a drug is substandard or its registration is cancelled or suspended, the Licensing Authority may order the product to be withdrawn from the market and destroyed; after confirmation of…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Prior approval of claim advertisements
No person may publish, disseminate or participate in any advertisement containing a claim regarding the use of a drug, or its curative or treatment effect, without prior approval of the Lic…
1 source-linked fact
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Reconsideration or appeal within 30 working days
Where registration is suspended and production/marketing halted, the person or establishment may, within 30 working days, apply to the Licensing Authority for reconsideration of the order o…
1 source-linked fact
Checked 2026-08-25
Open details →

DGDA registration fees in BDT · reviewed 2026-08-25

Fee lineAmountProvenance
Preliminary registration ("recipe") approval for import of a drug, medical device or IVD reagentBDT 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 registrationBDT 10,000 (BDT 11,500 with VAT)Verified

Registration timeline

Full registration timeline

Directorate General of Drug Administration (DGDA) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathwayReview clockPlanning totalProvenance
All classes — stage 1, preliminary registration ("recipe") for import(DGDA preliminary registration approval)90 working days5-9 monthsVerified
All classes — stage 2, grant of import registration(DGDA import registration)90 working days1-1.7 yearsVerified
All classes — block import approval for a registered device(DGDA block import permission)40 working days2-4 monthsVerified
All classes — renewal of import registration(DGDA registration renewal)60 working days3-6 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(90 working days)
  5. 5Registration Approval(1-2 weeks)

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

Policy Document 2024DGDA Medical Devices Policy Document 2024 (PDF)
GeneralVerified
DGDADirectorate General of Drug Administration - Medical Devices
GeneralVerified
Drug (Control) Ordinance 1982Drug (Control) Ordinance 1982 - Foundation Legislation
GeneralVerified
Application FormsMedical Device Registration and Import Forms
RegistrationVerified

Computed from 4,422 official DGDA registration records · data as of 2026-08-22

New registrations by year
2020202120222023202420252026
VerifiedDGDA registry · as of 2026-08-22
4,422
Registrations
1,693
Manufacturers
1,211
Authorized Representatives
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