DGDA · structured requirements

🇧🇩 Bangladesh IVD regulatory data

Explore the IVD requirements currently available for Bangladesh, organized by topic and linked to official sources.

2 facts1 dimensions1 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in Bangladesh. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

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.

Bangladesh approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Bangladesh (4 records)

BangladeshUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: 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.
Timeline Savings: None published

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

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

BangladeshNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: bangladesh
China Classes In Scope: Bangladesh Class B (NMPA Class I/II equivalents); also the origin-FSC component for Class C/D
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Class B: FSC from country of origin
Regulatory status in the country of manufacture and other developed economies must be declared; list of countries where marketed; recall history in last two years
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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,

BangladeshNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

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-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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: bangladesh
China Classes In Scope: Bangladesh Class C and D (NMPA Class II/III equivalents)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Class C/D: FSC from one of EU, USA, Canada, Australia, Japan AND FSC from country of origin
Conformity assessment certificate or equivalent must also be submitted
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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.

BangladeshEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: Usable as supporting technical evidence on the same terms, with no recognition route and no published reduction.
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Related structured datasets

Classification systems · 1 record

Open Risk classes A through D. →

bangladesh:medical-device

Jurisdiction Id

bangladesh

Domains

medical-device
ivd

Name

Risk classes A through D.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

DGDA

Official Domains

dgda.gov.bd

Source Status

official-source-verified

Source Title

DGDA medical-device registration guidance, Section 4.4-4.6 and Annexure 1 (GHTF-based classification rules)

Source Url

https://objectstorage.ap-dcc-gazipur-1.oraclecloud15.com/n/axvjbnqprylg/b/V2Ministry/o/office-dgda/2026/2/7a5e0614-3420-492b-8923-d85ce44e5a15.pdf

Verified On

2026-08-25

Source Supports

class-axis
classification-rules
ivd-class-axis
ivd-classification-rules

Notes

GHTF-based Annexure 1 rules cover general devices and IVDs; where a product does not follow those rules, internationally accepted classification may be accepted by DGDA.
Route split: Class A under sole manufacturer responsibility with Declaration of Conformity informing DGDA (no manufacturing licence); Classes B/C/D require notified-body QMS certification (Class D also design certification) and DGDA registration.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Bangladesh registration →

Country

Bangladesh

Jurisdiction Id

bangladesh

Country Code

Flag

🇧🇩

Regulator

Directorate General of Drug Administration

Regulator Abbrev

DGDA

Region

asia-pacific

Tier

Risk Classification

4-class (A, B, C, D)

Classes

Id
preliminary-registration-recipe
Class Name
All classes — stage 1, preliminary registration ("recipe") for import
Pathway
DGDA preliminary registration approval
Official Timeline
Min
90
Max
90
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Effective Date
2023-06-25
Accessed Date
2026-08-30
Realistic Timeline
Min
5
Max
9
Unit
months
Notes
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
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
import-registration
Class Name
All classes — stage 2, grant of import registration
Pathway
DGDA import registration
Official Timeline
Min
90
Max
90
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Effective Date
2023-06-25
Accessed Date
2026-08-30
Realistic Timeline
Min
12
Max
20
Unit
months
Notes
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
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
block-import-approval
Class Name
All classes — block import approval for a registered device
Pathway
DGDA block import permission
Official Timeline
Min
40
Max
40
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Effective Date
2023-06-25
Accessed Date
2026-08-30
Realistic Timeline
Min
2
Max
4
Unit
months
Notes
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
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
registration-renewal
Class Name
All classes — renewal of import registration
Pathway
DGDA registration renewal
Official Timeline
Min
60
Max
60
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Effective Date
2023-06-25
Accessed Date
2026-08-30
Realistic Timeline
Min
3
Max
6
Unit
months
Notes
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
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes

Prior Approvals

Authority
FDA 510(k)
Accepted
Yes
Benefit
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.
Timeline Savings
None published
Authority
EU CE Mark
Accepted
Yes
Benefit
Usable as supporting technical evidence on the same terms, with no recognition route and no published reduction.
Timeline Savings
None published

Key Requirements

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

Local Rep Required

Yes

Local Rep Name

Bangladesh Local Agent

Mdsap Accepted

Mdsap Benefit

Not accepted

Registration Validity

5 years

Last Updated

2026-08-30

Verification Status

partially-verified

Official Sources

Title
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
Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Effective Date
2023-06-25
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by DGDA. Appoint a Bangladesh Local Agent.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to DGDA including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
DGDA reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. DGDA may issue questions.
Duration
90 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, DGDA issues Bangladesh market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Bangladesh fees →

Jurisdiction Id

bangladesh

Country

Bangladesh

Country Code

Authority

DGDA

Low Risk Local

Min: 63250
Max: 63250
Currency: BDT
Per Product: Yes

High Risk Local

Min: 63250
Max: 63250
Currency: BDT
Per Product: Yes

Details

Id
preliminary-registration-recipe
Item
Preliminary registration ("recipe") approval for import of a drug, medical device or IVD reagent
Currency
BDT
Amount Local
5000
Amount Local Formatted
BDT 5,000 (BDT 5,750 with VAT)
Frequency
Per application
Notes
Citizen Charter item 24; paid by treasury challan under code 1-2715-0000-1863 with 15% VAT under code 1-1-1133-0015-0311.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Source Title
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
Source Effective Date
2023-06-25
Verified On
2026-08-25
Id
import-registration
Item
Grant of import registration (registration and analysis fee)
Currency
BDT
Amount Local
50000
Amount Local Formatted
BDT 50,000 (BDT 57,500 with VAT)
Frequency
Per registration
Notes
Citizen Charter item 25; the same fee applies whatever the device class, because DGDA prices the service and not the risk class.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Source Title
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
Source Effective Date
2023-06-25
Verified On
2026-08-25
Id
registration-renewal
Item
Renewal of import registration
Currency
BDT
Amount Local
10000
Amount Local Formatted
BDT 10,000 (BDT 11,500 with VAT)
Frequency
Every 5 years
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Source Title
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
Source Effective Date
2023-06-25
Verified On
2026-08-25

Notes

A first import registration costs both charter line items — BDT 5,000 for the preliminary "recipe" approval and BDT 50,000 for the registration itself — so the all-in statutory cost is BDT 55,000 plus 15% VAT, which is BDT 63,250 per product.
DGDA does not price by risk class: the charter treats drugs, medical devices and IVD reagents as one service, so Class A carries the same fee as Class D and the widely quoted "Class A is free" position has no official basis.
The gazetted Registration Guidelines for Medical Devices leave the amount blank in Annexure-2 ("Prescribed fees of Taka ______ shall be paid along with the application"), which is why the Citizen Charter rather than the gazette is the fee source of record.
Block import approval (charter item 28) and the customs release certificate (item 30) are free of charge.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
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
Url
https://dgda.gov.bd/pages/office-citizen-charters/6922d8a9933eb65569df99e6
Effective Date
2023-06-25
Accessed Date
2026-08-25
Title
Registration Guidelines for Medical Devices Bangladesh (Bangladesh Gazette No. 42 of 2019), Annexure-2 "Procedure for application"
Url
https://dpp.gov.bd/upload_file/gazettes/33970_33126.pdf
Effective Date
2019-01-01
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Bangladesh certifications →

Slug

bangladesh

Market

Bangladesh

Confidence

low

Schemes

Id
medical-electrical-evidence
Name
Medical electrical evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Source Binding
unresolved
Id
btrc-radio-equipment-approval-enlistment
Name
BTRC radio equipment approval/enlistment
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Source Urls
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
Source Binding
candidate

Official Sources

Authority
BTRC
Topic
radio equipment import, use, market and enlistment guideline
Url
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

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