Medical Device Registration — Device registration, built around evidence and market readiness.
Ziva DRA supports medical device manufacturers and international companies with regulatory pathway assessment, documentation, registration coordination and ongoing compliance for the Bangladesh market.
Bangladesh contextLocal regulatory and operating perspective.
Connected expertiseRelevant workstreams aligned around one objective.
Decision-ready outputClear priorities, dependencies and next steps.
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Medical device registration in Bangladesh is the approval the Directorate General of Drug Administration (DGDA) gives before a Class B, C or D device is imported. Under DGDA's 2015 guideline, a local authorized agent applies for the manufacturer, unless the manufacturer applies through its own office in Bangladesh.
DGDA medical device registration fees total BDT 63,250 per product for Class B, C and D devices, including 15% VAT. Ziva DRA supports medical device manufacturers and international companies with regulatory pathway assessment, documentation, registration coordination and ongoing compliance for the Bangladesh market.
Drug and Cosmetics Act 2023 (Act No. 29 of 2023). DGDA still publishes its 2015 device guideline and checklist
Who applies
DGDA's 2015 guideline, Annexure-2: a local authorized person or agent, or the manufacturer's own office in Bangladesh; section 4.6: manufacturers and/or importers
Classes that must register
Class B, C and D, before import or manufacture. Class A will be declaration.
Stages (Class B, C and D)
Recipe approval (DGDA's first stage), then registration
DGDA fees per product (Class B, C, D)
BDT 63,250 including 15% VAT
Validity
Five years for drug registrations under the 2023 Act. Devices count as drugs. Class A product does not require any government fees.
DGDA processing time limit
90 working days for recipe approval and 90 for registration of imported devices, from a complete application (Citizen's Charter)
Renewal
BDT 10,000 plus 15% VAT and 60 working days from a complete application, for imported devices (Citizen's Charter)
Support from Ziva DRA
Regulatory assessment, classification support, document gap review, application preparation, regulatory follow-up and lifecycle compliance
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What Is Medical Device Registration in Bangladesh?
Medical device registration in Bangladesh means DGDA's approval of a Class A, B, C or D device before it is imported, sold in the country.
The Drug and Cosmetics Act 2023 treats a medical device as a drug. DGDA's recipe and registration checklist sets two stages for Class B, C and D devices, and Class A devices follow a lighter route under the 2015 guideline.
Which Law and Regulator Apply?
DGDA regulates medical devices in Bangladesh under the Drug and Cosmetics Act 2023 (Act No. 29 of 2023).
Section 22(1) of the Act bars importing, selling or stocking a drug without registration, and a medical device counts as a drug. Under section 22(3), DGDA registers a drug on the recommendation of the Drug Control Committee.
Bangladesh replaced the Drugs Act 1940 and the Drugs (Control) Ordinance 1982 with the 2023 Act. DGDA still publishes its Registration Guidelines for Medical Devices, Bangladesh 2015, and its recipe and registration checklist is issued under that guideline.
DGDA's 2015 guideline was written under the 1940 Act and still cites it on page 5.
Which Products Count as Medical Devices?
The 2023 Act's medical device definition is broad: instruments, apparatus, implants, software and diagnostic reagents used on people or animals to diagnose, prevent, monitor or treat disease.
Examples inside the definition:
Instruments and apparatus, such as surgical retractors and lung ventilators.
Implants, such as bone fixation plates and heart valves.
Software that meets the definition.
In vitro diagnostic reagents (IVD reagents), which Ziva DRA covers on its own page for IVD registration.
Some products are medical devices in some countries and not in others. DGDA's guideline says these follow the rules of their country of origin. Examples are disinfection substances, aids for persons with disabilities, devices with animal or human tissue and in-vitro fertilization devices.
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Which Medical Devices Must Be Registered in Bangladesh?
Class B, C and D medical devices must be registered with DGDA before they are imported or manufactured in Bangladesh, and Class A devices follow a lighter route.
DGDA's rule works by class. Annexure 4 of the 2015 guideline is a medical device list that gives a keyword, a therapeutic code, a class and a description for listed device types. It shows an ophthalmic aberrometer as Class B, for example.
The Four DGDA Risk Classes
DGDA's medical device classification groups devices into four classes, A to D, by risk level and intended use.
Class
Risk level
DGDA's example devices
Route
A
Low risk
Examination gloves, Cannula fixator
Declaration of Conformity and a DGDA certificate
B
Low-moderate risk
Hypodermic needles, suction equipment, IV Cannula
Registration in two stages
C
Moderate-high risk
Lung ventilator, bone fixation plate, Surgical Sutures
The examples come from Figure 1 of DGDA's 2015 guideline, which presents them as illustrations. The manufacturer applies the classification rules to its own device by intended purpose.
As a general rule, Class A medical device registration follows a lighter route: the manufacturer assesses conformity under its own responsibility and informs DGDA through a Declaration of Conformity.
Section 4.5 of DGDA's 2015 guideline describes this route. DGDA's checklist lists four items for a Class A certificate application:
A copy of the Agency Agreement.
A copy of the Free Sale Certificate.
The product dossier or brochure.
A sample of the device.
DGDA publishes lists of registered Class A devices.
What Happens When a Device Fits Two Classes
DGDA's 2015 guideline applies the highest class when a device has features that place it in more than one class.
The class depends on the manufacturer's claims and intended use. Check your intended-use statement before you file.
Not sure which DGDA class your device falls into?
Share your device information and current regulatory status with Ziva DRA so the appropriate registration and documentation pathway can be assessed.
Do Foreign Manufacturers Need a Local Authorized Agent in Bangladesh?
Yes: DGDA requires a local authorized agent for Class A, B, C and D medical devices in Bangladesh, unless the manufacturer applies through its own office there.
Section 4.6 of DGDA's guideline says manufacturers and/or importers apply for registration. Annexure-2 says a manufacturer with its own office in Bangladesh can apply through that office, and a manufacturer without one needs a local authorized agent. For Class A, DGDA's checklist lists a copy of the Agency Agreement with the certificate application.
What DGDA Requires From the Applicant
Annexure-2 of DGDA's 2015 guideline says a local authorized person or agent of the manufacturer or foreign supplier makes the application.
DGDA's guideline defines an authorized representative as a person or legal entity established in the country. The representative holds a written mandate from the manufacturer to act on its behalf for specified tasks.
The application carries:
The local agent's name, address, phone number and email.
The manufacturer's original authorization letter, which is not needed when the manufacturer applies through its own office in Bangladesh.
The company that places the product on the market, if it is not the manufacturer.
Details of the local manufacturer, if part processing is planned in Bangladesh.
The product details, the countries where the device is marketed and any regulator-led withdrawal or recall in the last two years.
How Ziva DRA Helps With the Local Authorized Representative
International manufacturers may require a Bangladesh-based regulatory interface, depending on the product and the market-entry model. Ziva DRA assesses the right structure and connects it with the wider registration program.
Our regulatory affairs page describes the local authorized representative under Bangladesh local support.
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How Does Medical Device Registration Work in Bangladesh?
The medical device registration process in Bangladesh has two DGDA stages for Class B, C and D devices: recipe approval first, then registration. In recipe approval, DGDA approves the commercial name, legal manufacturer and manufacturing site as stated.
Step
What you submit
DGDA fee
Source
Before you apply
Class decision; local agent with the manufacturer's original authorization letter, or the manufacturer's own office
Before you file, confirm the device class, appoint a local authorized agent unless you apply through your own office, and assemble the file.
Confirm the class from the device's intended use.
Appoint your local authorized agent and give it your original authorization letter, unless you apply through your own office in Bangladesh.
Assemble the documents for your class from DGDA's checklist.
Ziva DRA's DGDA registration checklist report combines a structured registration checklist with sample document references to support the preparation and review of submissions to DGDA.
Stage 1: Recipe Approval
DGDA recipe approval is the first stage for Class B, C and D devices: you file the documents for your class with the recipe fee.
The filing has these parts:
The documents for your class.
The recipe fee of BDT 5,000 plus 15% VAT per product, paid by TR challan, the Treasury challan that proves payment. Additionally, BDT 500 per product pay order has to be submitted with application.
An application on letterhead, with the original fee challans attached.
DGDA's checklist notes that DGDA approves the commercial name, legal manufacturer and manufacturing site as stated, so a later change to them needs a new recipe approval application.
For imported devices, DGDA's Citizen's Charter titles this stage primary registration (recipe) approval and lists 90 working days for it, counted from a complete application.
Stage 2: Registration
The DGDA registration stage comes second, after recipe approval: you submit original certificates, the registration and analysis fee and two sets of packaging.
The filing has these parts:
The original Free Sale Certificate attested by the Bangladesh Embassy.
For Class C and D, a second original Free Sale Certificate from one of these markets: an EU country, the USA, Canada, Australia or Japan.
The original EC certificate, the list of countries where the device is marketed and details of any regulator-led withdrawal or market recall in the last two years.
The registration and analysis fee of BDT 50,000 plus 15% VAT per product.
Two sets of packaging.
DGDA issues registration on the basis of these documents and an inspection, if required (guideline section 4.6). Registration follows the Drug Control Committee's recommendation under section 22(3) of the 2023 Act. For imported devices, DGDA's Citizen's Charter lists 90 working days for this stage, counted from a complete application.
After Registration: Renewal, Changes and Vigilance
A registered device needs three follow-up actions: renewal, change control and vigilance reports.
Renew before expiry: the 2023 Act sets five years for drug registrations, which include devices, and a renewal application is made no more than 90 days before expiry.
Request a new recipe approval for a change of commercial name, legal manufacturer or manufacturing site.
Submit vigilance reports on serious adverse events for Class B, C and D devices to DGDA within 10 working days of learning of the incident, as DGDA's 2015 guideline asks.
For imported devices, the renewal fee in DGDA's Citizen's Charter is BDT 10,000 plus 15% VAT, BDT 11,500 in total. The processing time limit is 60 working days from a complete application.
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What Documents Does DGDA Require for Medical Device Registration?
The documents required for medical device registration in Bangladesh differ by class and by stage in DGDA's checklist.
Documents for Recipe Approval
DGDA's checklist lists 9 documents required for recipe approval for Class B and 10 for Class C and D.
Document
Class B
Class C and D
Agency Agreement copy
Yes
Yes
Free Sale Certificate copy, country of origin
Yes
Yes
Free Sale Certificate copy, one of: an EU country, the USA, Canada, Australia or Japan
No
Yes
EC certificate copy
Yes
Yes
Product dossier or brochure
Yes
Yes
TR challan for the BDT 5,000 recipe fee
Yes
Yes
Copy of the TR challan for 15% VAT
Yes
Yes
Application checklist (Annexure-3), filled in
Yes
Yes
Photocopy of packaging
Yes
Yes
Letterhead application with the original challans
Yes
Yes
DGDA's checklist asks for a product dossier or brochure. It does not list a CSDT.
Documents for Registration
DGDA's checklist lists 7 registration documents for Class B and 8 for Class C and D.
The documents are original certificates, a list of marketing countries, recall details, fee challans and two sets of packaging.
Document
Class B
Class C and D
Original Free Sale Certificate, country of origin, attested by the Bangladesh Embassy
Yes
Yes
Original Free Sale Certificate, one of: an EU country, the USA, Canada, Australia or Japan
No
Yes
Original EC certificate
Yes
Yes
List of countries where the device is marketed
Yes
Yes
Details of any regulator-led withdrawal or market recall in the last two years
Yes
Yes
TR challan for the BDT 50,000 registration and analysis fee
Yes
Yes
Copy of the TR challan for 15% VAT
Yes
Yes
Two sets of packaging
Yes
Yes
Free Sale Certificates and Embassy Attestation
DGDA's guideline and checklist ask for a Free Sale Certificate (FSC) of the country of origin at both stages, and the original must carry Bangladesh Embassy attestation.
Class B needs the FSC of the country of origin: a copy at recipe approval and, at registration, the original with Bangladesh Embassy attestation.
Class C and D need that certificate plus an FSC from one of these markets: an EU country, the USA, Canada, Australia or Japan.
Want your documents checked before you file?
A documentation and gap review can be useful before defining the final registration scope.
How Much Does Medical Device Registration Cost in Bangladesh?
Registering a medical device in Bangladesh costs BDT 63,250 per product in DGDA fees for a Class B, C or D device, including 15% VAT.
The total is BDT 5,000 for recipe approval plus BDT 50,000 for registration and analysis, with 15% VAT on both.
DGDA Government Fees
DGDA charges two medical device registration fees per product for Class B, C and D devices, and 15% VAT applies to both.
Fee
Amount
VAT at 15%
Total
Recipe approval fee
BDT 5,000
BDT 750
BDT 5,750
Registration and analysis fee
BDT 50,000
BDT 7,500
BDT 57,500
Total per product
BDT 55,000
BDT 8,250
BDT 63,250
DGDA's checklist shows no government fee line for Class A.
One application can cover up to five similar devices from the same premises, and DGDA's fee is charged per product.
For imported devices, the renewal fee in DGDA's Citizen's Charter is BDT 10,000 plus 15% VAT, BDT 11,500 in total.
Convert the BDT amounts at the exchange rate on the day you pay.
Source: DGDA recipe and registration checklist, pages 1 and 2, Annexure-2 of the 2015 guideline and DGDA's Citizen's Charter, read on November 2, 2026.
Agent Fees
Agent fees are separate from DGDA's fees and the VAT, which are paid by TR challan, the Treasury challan that proves payment. Ask any agent what it charges before you sign.
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How Long Does Medical Device Registration Take in Bangladesh?
For medical device registration in Bangladesh, DGDA's Citizen's Charter lists time limits of 90 working days for recipe approval and 90 for registration.
The limits are counted from a complete application and cover imported devices.
What DGDA Publishes About Timing
DGDA's Citizen's Charter lists a processing time limit for each stage of registering an imported device, and for renewal.
DGDA service
Processing time limit
DGDA fee
Recipe approval
90 working days
BDT 5,000 plus 15% VAT
Registration
90 working days
BDT 50,000 plus 15% VAT
Registration renewal
60 working days
BDT 10,000 plus 15% VAT
The charter covers imported medicines, medical devices and IVD reagents, and it names the drug importer as the service recipient. Annexure-2 of DGDA's 2015 guideline names a local authorized person or agent as the applicant.
What to Ask Your Agent About Timing
Ask any agent for the elapsed times of its recent files, by class and stage, with dates. Compare them with the 90 working days that DGDA's Citizen's Charter lists for each stage of an imported device.
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What Does Ziva DRA's Medical Device Registration Service Include?
Ziva DRA's medical device registration service covers six support lines, from regulatory assessment, classification support and document gap review to lifecycle compliance.
The exact scope of a project depends on the device and the regulatory requirements.
Support line
What it covers
Regulatory Assessment
Reviews device information, intended use, current approvals and the market-entry objective before the registration pathway is defined
Classification Support
Supports the assessment of the device category and the regulatory route relevant to registration
Document Gap Review
Compares available technical and regulatory documents against the anticipated registration requirements
Application Preparation
Organizes the required application information and supporting documentation for submission
Regulatory Follow-up
Coordinates relevant communication, clarification and follow-up during the registration process
Lifecycle Compliance
Supports applicable post-registration, renewal or continuing compliance activities
Our regulatory dossier preparation page covers gap assessment, dossier structuring, market adaptation and a pre-submission readiness review.
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How Do You Choose a Regulatory Agent for Bangladesh?
Choose a regulatory agent for DGDA registration by checking who is named on the application, what the application carries and what its files show.
Five Questions to Ask Any Agent Before You Sign
Ask five questions before you sign with an agent for DGDA registration.
Who is named as the applicant on the DGDA forms? Annexure-2 of DGDA's 2015 guideline names a local authorized person or agent, or the manufacturer's own office, and section 4.6 names manufacturers and/or importers.
Which details will the application carry? Annexure-2 names the agent's contact details, the company that places the product on the market and the local manufacturer, if part processing is planned in Bangladesh.
Which documents does the agent check before filing? DGDA's checklist differs for Class B and for Class C and D.
Which files like yours has the agent handled, and how long did the stages take? Ask for counts and dates.
Which fees are the agent's and which are DGDA's? DGDA's fees for Class B, C and D devices total BDT 63,250 per product.
About Ziva DRA
Ziva DRA provides regulatory affairs and market access services in Bangladesh and lists addresses in Dhaka, Kunming and Sheridan, Wyoming. See our team and Why Ziva DRA.
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Sources and Last Review
The cited parts of these sources were last checked on November 2, 2026.
Ziva DRA offers medical device registration services, so it has a commercial interest in this topic.
Where a source is in Bengali, the English wording on this page is a reading of the original, not an official translation.
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Start Your Medical Device Registration in Bangladesh
Start a project with Ziva DRA to register a medical device in Bangladesh: send your product name, intended use and class, if you know it. Ziva DRA supports the work from the first regulatory assessment to lifecycle compliance.
Medical Device Registration in Bangladesh: Frequently Asked Questions
Is medical device registration mandatory in Bangladesh?
Registration is mandatory in Bangladesh for Class B, C and D medical devices: DGDA's guideline says they must be registered before they are imported or manufactured. Class A devices follow a lighter route with a Declaration of Conformity. The 2023 Act bars importing or selling a drug, which includes a medical device, without registration.
Do foreign manufacturers need a local agent in Bangladesh?
Foreign manufacturers need a local authorized agent in Bangladesh for Class B, C and D devices, unless they apply through their own office there. Annexure-2 of DGDA's 2015 guideline requires a local authorized person or agent to apply, with the manufacturer's original authorization letter. The application names the agent's address, phone number and email.
How much does DGDA charge to register a medical device?
DGDA's fees total BDT 63,250 per product for Class B, C and D devices, including 15% VAT. That is BDT 5,000 for recipe approval and BDT 50,000 for registration and analysis, plus 15% VAT on both. DGDA's checklist shows no government fee line for Class A.
What processing time does DGDA state for medical device registration?
The processing time limit in DGDA's Citizen's Charter is 90 working days for recipe approval and 90 for registration of imported devices. Renewal has a limit of 60 working days, and each limit is counted from a complete application. Ask your agent for the elapsed times of its recent files, by class and stage, with dates.
How long is a medical device registration valid in Bangladesh?
The 2023 Act sets a five-year validity for drug registrations, and a medical device counts as a drug under the Act. A renewal application is made no more than 90 days before expiry. For imported devices, DGDA's Citizen's Charter lists a renewal fee of BDT 10,000 plus 15% VAT and a 60-working-day limit from a complete application.
Is a CE mark or FDA approval enough to sell a medical device in Bangladesh?
A CE mark or FDA approval is not enough in Bangladesh: Class B, C and D devices still need DGDA registration. DGDA's guideline says manufacturers with overseas quality-system certification or marketing authorization must produce those documents for DGDA's consideration. DGDA's checklist asks for the EC certificate and, for Class C and D, a second Free Sale Certificate.
Can one application cover more than one medical device?
One application can cover up to five similar devices made at the same premises, such as five catheters or five stents. Separate applications and fees apply to separate manufacturing premises, to separate products and to a group of more than five products, according to Annexure-2 of DGDA's 2015 guideline.
What is recipe approval at DGDA?
Recipe approval is the first of two DGDA stages for Class B, C and D devices. You file the agency agreement, free sale certificate copies, EC certificate copy, product dossier or brochure, Annexure-3 checklist and packaging photocopy. The TR challans for the BDT 5,000 fee and 15% VAT go with a letterhead application. Registration follows.
Does DGDA require a CSDT or an ISO 13485 certificate?
DGDA's checklist asks for a product dossier or brochure and does not list a CSDT. DGDA's 2015 guideline requires quality management system certification from a notified body for Class B, C and D, and design certification for Class D. DGDA's guideline names ISO 13485 among the standards it adopts.
Who reports serious adverse events for a registered device?
The manufacturer or importer reports serious adverse events for Class B, C and D devices to DGDA. DGDA's 2015 guideline asks manufacturers to submit vigilance reports within 10 working days from the date the incident becomes known. Post-marketing surveillance applies once a Class B, C or D device is on the market in Bangladesh.
Device registration, built around evidence and market readiness.
Discuss the applicable pathway, requirements and next steps with Ziva DRA.
