Explore the medical device requirements currently available for Bangladesh, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
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 Licensing Authority.
What expires, what is retained periodically, and when must renewal start?
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.
90-day pre-expiry renewal window for licences: ধারা ১৫(২).
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 Certificate remains valid as long as the registration is valid.
ধারা ২৩(২): নিবন্ধন নবায়নযোগ্য হইবে এবং মেয়াদ উত্তীর্ণ হইবার অনধিক ৯০ (নব্বই) দিন ধারা ২৩(৪): ঔষধের নিবন্ধন বহাল ও কার্যকর থাকাকালীন সময় পর্যন্ত মার্কেটিং অথরাইজেশন সনদ একইরূপে বহাল ও কার্যকর থাকিবে।
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Without prior approval of the Licensing Authority, no new manufacturing project may be undertaken nor an ongoing project expanded.
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 for cancellation or temporary suspension of the licence.
Suspension/cancellation requires prior notice with reasons and time limit and an opportunity to submit a written reply (ধারা ১৮(২)).
Which clinical or IVD performance evidence or study is required and accepted?
Pre-clinical, clinical, field or performance trials and biocompatibility or bioequivalence studies on drugs, vaccines and medical devices are conducted by Contract Research Organizations; they require the Licensing Authority's approval plus separate protocol approval, without which no such study may be conducted on any medical product used in the treatment of humans or animals.
Other sub-sections of ধারা ৬৫ cover government-approved GCP guidelines, ethics committee oversight, investigational-product import and sample-export approvals, and fast-track approval for emergency/pandemic products; guideline s.13 addresses clinical investigations for Class B/C/D devices.
Is the product a device, IVD, accessory, software, or borderline product locally?
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 2023.
The drug definition also covers vaccines/biologicals, pharmacopoeia substances and traditional/herbal medicines in other clauses of ধারা ২(৫).
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 or related article used, alone or in combination, for medical purposes in humans or animals; the Government may declare further devices and diagnostic reagents by gazette notification.
Non-pharmacological-action clause of ধারা ২(৩৩): যাহার কাঙ্খিত কার্যক্রম ফার্মাকোলজিক্যাল, ইমিউনোলজিক্যাল বা মেটাবলিক ক্রিয়ার দ্বারা সংঘটিত হয় না। Gazette-extension power: ধারা ২(৩৩)(খ).
Which evidence, local deltas, formats, and signatures are required?
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 than 5 products; separate applications (and fees) are required beyond that and for separate premises.
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 evidence.
Product details also cover class per GHTF, description, sizes, principal use, manufacturing process with flow diagram, labelling/packaging details, accessories, predicates, and applicable ISO/ASTM/IEC/AAMI standards.
Applicants for registration and Marketing Authorization Certificates must present, on demand of the Licensing Authority, satisfactory information on the quality, safety and efficacy of the drug (including the device); clinical trial or bioequivalence study data may be required for specific products.
Clinical trial / bio-equivalence study data on demand: ধারা ২২(১০).
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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 manufacture drugs (including devices) within Bangladesh.
Proviso of ধারা ২০(১) adds the precondition that the manufacturer's research-based product is registered in a country listed under ধারা ৪১(৩). Loan-licence/contract-manufacturing arrangements continue under ধারা ২১.
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 from the manufacturer authorising the local agent to be the applicant must be submitted.
Annexure-2 detail: Authorisation letter, in original, from the manufacturer authorising the local agent to be the applicant.
Which establishment licences, importer permissions, and distribution controls apply?
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; manufacturing a new project or expanding an ongoing project requires prior approval of the Licensing Authority.
Proviso: লাইসেন্সিং কর্তৃপক্ষের পূর্বানুমোদন ব্যতীত, ঔষধ উৎপাদনের জন্য কোনো নূতন প্রকল্প গ্রহণ কিংবা চলমান প্রকল্পের সম্প্রসারণ করা যাইবে না। Internet/web-based sale also requires a licence (ধারা ১৪(২): কোনো ব্যক্তি বা প্রতিষ্ঠান লাইসেন্সিং কর্তৃপক্ষ কর্তৃক প্রদত্ত লাইসেন্স ব্যতীত অথবা লাইসেন্সে আরোপিত শর্ত বহির্ভূতভাবে ক…); premises must pass inspection before grant/renewal (ধারা ১৬).
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; import of registered raw materials, packaging materials and semi-finished drugs likewise requires prior approval.
ধারা ৪১(১): লাইসেন্স ব্যতীত বা লাইসেন্সে আরোপিত শর্ত বহির্ভূতভাবে কোনো ধরনের ঔষধ আমদানি করা যাইবে না। Export licence: ধারা ৪৩.
What regulator fee applies to this class, route, event, and date?
The Licensing Authority will not register (or renew the registration of) any drug, including devices, unless the fee determined under the rules is paid; registration, renewal and, as applicable, late fees are determined by rules and may be revised by the Government from time to time by gazette notification.
ধারা ২৪(১): ঔষধের নিবন্ধন ও নিবন্ধন নবায়ন ফি এবং, ক্ষেত্রমত, বিলম্ব ফি, বিধি দ্বারা নির্ধারিত হইবে :
Which label and IFU elements, languages, symbols, and translation controls apply?
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 15223-1:2007; labels must show date of manufacture or expiry (or both); imported devices may be further labeled by the importer under quarantine before release for sale; IFU/user manual (including e-labeling) is part of the dossier.
Symbols: Additionally relevant internationally accepted symbols denoting sterilization, single use etc. Act misbranding rule (ধারা ৩৭(৩)(খ)): উহা নির্ধারিত পদ্ধতিতে লেবেলযুক্ত না হইয়া থাকে।
Which current law, regulation, guidance, and transition provisions apply?
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.
Second listed document: আমদানিকৃত মেডিকেল ডিভাইস এর চেকলিস্ট ডাউনলোড Files-page last-updated stamp begins: বুধবার, ৪ মার্চ, ২০২৬ এ ০৩:৩৭ PM.
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 and English texts the Bangla text prevails.
Effective from 2023-09-18
ধারা ১(২) (Chapter 1): ইহা অবিলম্বে কার্যকর হইবে। ধারা ৮৩(২) (Chapter 14): এই আইনের বাংলা ও ইংরেজি পাঠের মধ্যে বিরোধের ক্ষেত্রে এই বাংলা পাঠ প্রাধান্য পাইবে।
The Drugs and Cosmetics Act 2023 repeals the Drugs Act 1940 and the Drugs (Control) Ordinance 1982; rules, notifications, orders, directions, forms, circulars and approvals made under them continue in force, as far as consistent with the new Act, until repealed, amended or re-made; licences, registrations and Marketing Authorization Certificates already issued are deemed issued under the new Act.
Effective from 2023-09-18
ধারা ৮২(২)(ক) savings: প্রণীত, জারীকৃত বা প্রদত্ত বিধিমালা প্রজ্ঞাপন, আদেশ, নির্দেশনা, ফরম, পরিপত্র, সার্কুলার, অনুমোদন, ইত্যাদি এই আইনের সহিত সামঞ্জস্যপূর্ণ হওয়া সাপেক্ষে ধারা ৮২(৩)(ক) deeming: লাইসেন্সিং কর্তৃপক্ষ কর্তৃক প্রদত্ত বা ইস্যুকৃত লাইসেন্স, নিবন্ধন বা মার্কেটিং অথরাইজেশন সনদ অথবা কৃত কোনো কাজ, গৃহীত কোনো ব্যবস্থা বা সূচিত কোনো কার্যধারা এই আইনের অধীন প্রদত্ত, ইস্যুকৃত, কৃত গৃহীত ব Preserves continuity of old DGDA rules/forms (e.g. the 2015 device guideline) and of licences/registrations issued under the 1940/1982 regime.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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 performance of the device during use in Bangladesh, with corrective and preventive actions under the QMS to prevent recurrence of adverse events.
Which current form, portal, account, and submission package must be used?
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 application.
Fee line in the form template is blank: Prescribed fees of Taka _______ shall be paid along with the application. No online device-registration portal was verified on the DGDA pages opened; DGDA also publishes a checklist for imported medical devices on its Medical Device files page.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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 paid by the manufacturer at rates set by the Government.
Manufacturer pays inspection costs at prescribed rates (ধারা ৪১(৬)); same rule for raw-material/packaging registration (ধারা ৪২).
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; manufacturers/importers then apply for registration with documents specified by DGDA, and DGDA issues registration based on those documents and any inspection.
Guideline s.4.7 accepts foreign NRA/notified-body QMS or product certification and marketing authorization; assessment/certification expenses are borne by the manufacturer (s.4.8).
Drug (including device) manufacturers and sellers must follow WHO Good Practices (GxP) guidelines in manufacture, quality control, distribution, supply and storage.
Which recall, FSCA, notice, and authority-coordination duties apply?
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 immediately order sale stopped and marketing suspended until further instructions.
Substandard/counterfeit/misbranded manufacture, sale, stock, distribution and import prohibited (ধারা ৩৬-ধারা ৩৮); cancellation/suspension of registration follows notice and written reply (ধারা ২৫(৩)).
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 a harmful reaction, the establishment must destroy the product and inform the Licensing Authority.
Guideline s.9 safeguard clause: DGDA may take interim measures to withdraw devices, or prohibit/restrict placing on the market, and must immediately inform the manufacturer/importer of the reasons.
Which registration, notification, listing, reliance, or conformity route applies?
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 immediately for products already on the market when the guideline issued).
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 distributing, marketing or selling a registered product a Marketing Authorization Certificate (মার্কেটিং অথরাইজেশন সনদ) must be obtained; registration is not granted without the recommendation of the Drug Control Committee.
ধারা ২২(২): নিবন্ধনকৃত ঔষধ বিতরণ, বাজারজাত এবং বিক্রয়ের পূর্বে লাইসেন্সিং কর্তৃপক্ষের নিকট হইতে মার্কেটিং অথরাইজেশন সনদ গ্রহণ করিতে হইবে। ধারা ২২(৩): লাইসেন্সিং কর্তৃপক্ষ, ঔষধ নিয়ন্ত্রণ কমিটির সুপারিশ ব্যতীত, কোনো প্রকারের ঔষধ নিবন্ধন করিবে না। Baseline source PDF was dead (404); corrected to the Act as gazetted (official Bangladesh Gazette PDF hosted by DGDA).
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
FDA 510(k)
Yes
Usable as supporting technical evidence alongside the free sale certificate. The Citizen Charter sets one period per service and it does not vary with the origin of the device.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
The Department (DGDA) may, where necessary for a decision it is to adopt, follow the decision of an authority listed by the World Health Organization.
Statutory basis underlying DGDA reliance on WHO-listed authorities (e.g. the WHO Collaborative Registration Procedure edge above).
Prior approval / evidence record
For Class B devices the dossier requires the free sale certificate from the country of origin, and for Class C/D the country-of-origin FSC is required alongside a reference-country FSC. A China NMPA registration certificate or NMPA-based FSC satisfies the country-of-origin requirement for China-made devices; no abridged review follows.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
bangladesh
Bangladesh Class B (NMPA Class I/II equivalents); also the origin-FSC component for Class C/D
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2015-01-01
Source passage: 1. Regulatory status in the country of manufacture and in other developed economies : (a) For class B Devices, FSC from country of origin,
Regulatory reference
The Department (DGDA) may accept clinical-trial information or approved data obtained from foreign drug regulatory authorities.
Prior approval / evidence record
geo:bgd
WHO Prequalification of IVDs
Collaborative Abridged Registration
facilitated
Product Marketing
Yes
Yes
90
Working Days After Access To All Relevant Information
WHO page also states participation is voluntary and that the ultimate decision lies with the NRA, ensuring sovereignty of the country is maintained. Statutory backing: ধারা ৭৩ of the Drugs and Cosmetics Act 2023 (verified in the gazetted text) entitles the Department to follow decisions of WHO-listed authorities.
Regulatory reference
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-of-origin FSC. China/NMPA is not among the accepted reference countries, so a China-made Class C/D device cannot rely on its NMPA certificate alone.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
bangladesh
Bangladesh Class C and D (NMPA Class II/III equivalents)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2015-01-01
Source passage: (b) For class C and D Medical Devices , FSC from any one of the countries - EU, USA, Canada,Australia and Japan and FSC from country of origin. (c) Conformityassessment certificate or equivalent certificate has to be submitted.
Regulatory reference
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 brand name in the countries listed for this purpose; the Government publishes and updates that list of countries from time to time.
Prior approval / evidence record
EU CE Mark
Yes
Usable as supporting technical evidence on the same terms, with no recognition route and no published reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Dossier must include regulatory status evidence: for Class C and D devices a Free Sale Certificate from any one of EU, USA, Canada, Australia and Japan plus an FSC from the country of origin; a conformity-assessment certificate or equivalent must also be submitted. (Class B: FSC from country of origin.)
Guideline s.4.7 accepts QMS/product certification or marketing authorization issued by a National Regulatory Authority/notified body outside Bangladesh; a Device Master File is required only where CE/US FDA approvals are not available.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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, exhibitions and demonstrations with a visible sign that they cannot be marketed until compliant, and such imports can be re-exported after the purpose is served.
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 prescribed conditions.
Proviso: তবে শর্ত থাকে যে, উক্তরূপ নিবন্ধনের পর, অনধিক ৯০ (নব্বই) দিনের মধ্যে, উহা ঔষধ নিয়ন্ত্রণ কমিটির সুপারিশের জন্য পেশ করিতে হইবে।
The import prohibitions do not apply, under prescribed conditions, to small quantities imported for testing, analysis, research or personal use, nor to imports of any drug to meet a national crisis.
Parallel small-quantity exemption for manufacture in ধারা ১৪(১) proviso and for export in ধারা ৪৩(৩).
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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 or file an appeal with the Government; parties must be given a hearing, and the decision of the Licensing Authority or the Government is final.
Hearing and finality: ধারা ২৭(২)-ধারা ২৭(৩). Identical 30-working-day reconsideration/appeal right for licence suspension (ধারা ১৯(১)); notice-and-written-reply safeguards before suspension/cancellation (ধারা ২৫(৩), ধারা ১৮(২)).
Which UDI, device listing, database, and traceability duties apply?
The Department (DGDA) must publish on its website the list of registered drugs with prescribed information and update it from time to time.
What is reportable, by whom, where, in what format, and by what 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 manufacturer/importer.
Manufacturers, importers and marketing companies, hospitals, clinics, public-health-programme institutions and other stakeholders must mandatorily conduct pharmacovigilance activities for monitoring adverse drug reactions in humans or animals and send related reports and data to the Licensing Authority.
National Pharmacovigilance Guideline / GVP apply (ধারা ৬৬(২)).
bangladesh:medical-device
bangladesh
Risk classes A through D.
a
Class A
low
b
Class B
medium
c
Class C
high
d
Class D
highest
DGDA
official-source-verified
DGDA medical-device registration guidance, Section 4.4-4.6 and Annexure 1 (GHTF-based classification rules)
https://objectstorage.ap-dcc-gazipur-1.oraclecloud15.com/n/axvjbnqprylg/b/V2Ministry/o/office-dgda/2026/2/7a5e0614-3420-492b-8923-d85ce44e5a15.pdf
2026-08-25
Bangladesh
bangladesh
BD
🇧🇩
Directorate General of Drug Administration
DGDA
asia-pacific
3
4-class (A, B, C, D)
preliminary-registration-recipe
All classes — stage 1, preliminary registration ("recipe") for import
DGDA preliminary registration approval
90
90
working-days
official-verified
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 and 28-30 set the working-day clocks for drug/medical device/IVD reagent import registration, renewal and customs release
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
2023-06-25
2026-08-30
5
9
months
No
No
No
import-registration
All classes — stage 2, grant of import registration
DGDA import registration
90
90
working-days
official-verified
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 and 28-30 set the working-day clocks for drug/medical device/IVD reagent import registration, renewal and customs release
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
2023-06-25
2026-08-30
12
20
months
No
No
Yes
block-import-approval
All classes — block import approval for a registered device
DGDA block import permission
40
40
working-days
official-verified
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 and 28-30 set the working-day clocks for drug/medical device/IVD reagent import registration, renewal and customs release
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
2023-06-25
2026-08-30
2
4
months
No
No
No
registration-renewal
All classes — renewal of import registration
DGDA registration renewal
60
60
working-days
official-verified
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 and 28-30 set the working-day clocks for drug/medical device/IVD reagent import registration, renewal and customs release
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
2023-06-25
2026-08-30
3
6
months
No
No
Yes
FDA 510(k)
Yes
Usable as supporting technical evidence alongside the free sale certificate. The Citizen Charter sets one period per service and it does not vary with the origin of the device.
None published
EU CE Mark
Yes
Usable as supporting technical evidence on the same terms, with no recognition route and no published reduction.
None published
Yes
Bangladesh Local Agent
No
Not accepted
5 years
2026-08-30
partially-verified
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 and 28-30 set the working-day clocks for drug/medical device/IVD reagent import registration, renewal and customs release
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
2023-06-25
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by DGDA. Appoint a Bangladesh Local Agent.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to DGDA including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
DGDA reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. DGDA may issue questions.
90 working days
⚙️
5
Registration Approval
Upon successful review, DGDA issues Bangladesh market authorization certificate.
1-2 weeks
✅
bangladesh
Bangladesh
BD
DGDA
63250
63250
BDT
Yes
63250
63250
BDT
Yes
preliminary-registration-recipe
Preliminary registration ("recipe") approval for import of a drug, medical device or IVD reagent
BDT
5000
BDT 5,000 (BDT 5,750 with VAT)
Per application
Citizen Charter item 24; paid by treasury challan under code 1-2715-0000-1863 with 15% VAT under code 1-1-1133-0015-0311.
exact-current
official-verified
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 price the drug/medical device/IVD reagent import registration, its renewal, and the treasury and VAT codes they are paid under
2023-06-25
2026-08-25
import-registration
Grant of import registration (registration and analysis fee)
BDT
50000
BDT 50,000 (BDT 57,500 with VAT)
Per registration
Citizen Charter item 25; the same fee applies whatever the device class, because DGDA prices the service and not the risk class.
exact-current
official-verified
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 price the drug/medical device/IVD reagent import registration, its renewal, and the treasury and VAT codes they are paid under
2023-06-25
2026-08-25
registration-renewal
Renewal of import registration
BDT
10000
BDT 10,000 (BDT 11,500 with VAT)
Every 5 years
exact-current
official-verified
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 price the drug/medical device/IVD reagent import registration, its renewal, and the treasury and VAT codes they are paid under
2023-06-25
2026-08-25
2026-08-25
official-verified
ঔষধ প্রশাসন অধিদপ্তর সিটিজেন চার্টার (DGDA Citizen Charter) — items 24-26 price the drug/medical device/IVD reagent import registration, its renewal, and the treasury and VAT codes they are paid under
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
2023-06-25
2026-08-25
Registration Guidelines for Medical Devices Bangladesh (Bangladesh Gazette No. 42 of 2019), Annexure-2 "Procedure for application"
https://dpp.gov.bd/upload_file/gazettes/33970_33126.pdf
2019-01-01
2026-08-25
2026-08-25
exact-current
Yes
bangladesh
Bangladesh
low
medical-electrical-evidence
Medical electrical evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
unresolved
btrc-radio-equipment-approval-enlistment
BTRC radio equipment approval/enlistment
Radio Spectrum
Mandatory If Feature
Radio Equipment
candidate
BTRC
radio equipment import, use, market and enlistment guideline
https://btrc.gov.bd/site/notices/63a8992a-97cd-4be8-b696-46d21aced89f/%E0%A6%AC%E0%A7%87%E0%A6%A4%E0%A6%BE%E0%A6%B0-%E0%A6%AF%E0%A6%A8%E0%A7%8D%E0%A6%A4%E0%A7%8D%E0%A6%B0%E0%A6%AA%E0%A6%BE%E0%A6%A4%E0%A6%BF-%E0%A6%86%E0%A6%AE%E0%A6%A6%E0%A6%BE%E0%A6%A8%E0%A7%80-%E0%A6%AC%E0%A7%8D%E0%A6%AF%E0%A6%AC%E0%A6%B9%E0%A6%BE%E0%A6%B0-%E0%A6%AC%E0%A6%BE%E0%A6%9C%E0%A6%BE%E0%A6%B0%E0%A6%9C%E0%A6%BE%E0%A6%A4%E0%A6%AA%E0%A6%95%E0%A6%B0%E0%A6%A3-%E0%A6%8F%E0%A6%AC%E0%A6%82-%E0%A6%A4%E0%A6%BE%E0%A6%B2%E0%A6%BF%E0%A6%95%E0%A6%BE%E0%A6%AD%E0%A7%81%E0%A6%95%E0%A7%8D%E0%A6%A4%E0%A6%BF-%E0%A6%B8%E0%A6%A8%E0%A6%A6-%E0%A6%97%E0%A7%8D%E0%A6%B0%E0%A6%B9%E0%A6%A3%E0%A7%87%E0%A6%B0-%E0%A6%A8%E0%A6%BF%E0%A6%B0%E0%A7%8D%E0%A6%A6%E0%A7%87%E0%A6%B6%E0%A6%BF%E0%A6%95
