Bangladesh medical device regulations
Official sources linkedDGDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Quality Assurance Guideline 2025 | DGDA Quality Assurance Guideline for Medical Products (PDF) DGDA guideline for quality assurance of locally sourced medical products. Defines marketing authorization requirements and quality standards. | GMP/QMS | 2025 | Official |
| Policy Document 2024 | DGDA Medical Devices Policy Document 2024 (PDF) Official DGDA policy document for medical devices published January 2024. Contains classification requirements based on ASEAN guidelines (Class A-D). | General | 2024 | Official |
| DGDA | Directorate General of Drug Administration - Medical Devices DGDA under Ministry of Health and Family Welfare regulates medical devices in Bangladesh. Responsible for device registration, import licensing, and market surveillance. | General | 2019 | Official |
| Application Forms | Medical Device Registration and Import Forms Official application forms for medical device registration and import licensing. Includes registration forms, import permit applications, and supporting documents. | Registration | 2019 | Official |
| Import License | Medical Device Import License Requirements Import license requirements for foreign medical devices. Importers must hold valid import license and provide manufacturer authorization. | Registration | 2019 | Official |
| Medical Device Rules 2019 | Medical Device (Registration and Import) Rules 2019 Primary rules governing medical device registration and import in Bangladesh. Establishes classification, registration procedures, and import licensing requirements. | General | 2019 | Official |
| Device Registration | Medical Device Registration Requirements Registration requirements for medical devices in Bangladesh. All devices require DGDA registration before import or manufacture. | Registration | 2019 | Official |
| Drug (Control) Ordinance 1982 | Drug (Control) Ordinance 1982 - Foundation Legislation Foundation legislation establishing drug control framework in Bangladesh. Provides basis for medical device regulation under DGDA authority. | General | 1982 | Official |
Exports carry source + retrieval dateChanges after registration in Bangladesh
Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.
Does changing a device brand name or logo require an update?
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
How do I update a manufacturer's name without changing the legal entity?
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
What changes when the manufacturer's office address changes?
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Does a catalogue or reference code change affect registration or UDI?
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
Can a registration transfer to a different legal entity?
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Can several changes be filed together?
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Continue from regulations into practical research
Keep Bangladesh as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Classify a device for Bangladesh
Check a preliminary DGDA risk class.
Search registered products
Inspect public DGDA records.
Compare products across markets
Search the same product in multiple country registries.
Build a registration plan
Estimate pathway, government fees, preparation, and review time.
Build a reusable product master
Structure company, product, model, approval, and evidence facts once.
Map dossier reuse and deltas
Compare existing evidence against Bangladesh needs.
Build a market-launch workpaper
Connect route, evidence, labels, representatives, and launch dependencies.
Assess a regulatory change
Test a current DGDA update against one product and its evidence.