Guidance & Resources
DGDA · ISO standards · QMS · Grouping · Price controls
Official DGDA Documents
| Document | Content | Where to Find |
|---|---|---|
| DGDA Registration Guidelines for Medical Devices | Full registration procedure, Annexure 1 (classification rules), documentation checklists | www.dgda.gov.bd |
| Application forms | DGDA prescribed forms for registration, import licence, manufacturing licence | DGDA website / DGDA office |
| DGDA fee schedule | Official fees payable for registration, licensing, and certificates | DGDA website |
| GHTF guidance documents | Adopted by DGDA as basis for classification and registration requirements | DGDA website / GHTF archive |
Quality Management System (QMS) Requirements
ISO 13485 — Mandatory for Class B, C, D — BD-Unique
ISO 13485 certification is a mandatory prerequisite for DGDA registration of Class B, C, and D devices. There are no equivalent alternative quality system certifications accepted.
Requirements:
- Certificate issued by an internationally accredited certification body
- Scope must cover the specific product category being registered
- Must be current at the time of submission (not expired)
- Must cover the manufacturing site where the device is produced
Class A devices: ISO 13485 is not mandatory but demonstrates quality commitment. Class A manufacturers should still maintain appropriate quality documentation.
DGDA Recognition of QMS Certificates
DGDA recognises ISO 13485 certificates from internationally accredited CBs. There is no separate DGDA-specific QMS approval process — a valid ISO 13485 certificate from any accredited CB is accepted.
If a QMS certificate expires during the 5-year registration validity period, the AR must obtain an updated certificate and notify the DGDA.
Essential Principles of Safety and Performance
All registered devices must meet Bangladesh's essential principles, aligned with GHTF's framework:
General Requirements
- The device must be designed and manufactured to be safe when used as intended
- The device must achieve its claimed performance under its intended conditions of use
- Known and foreseeable risks must be minimised while benefits to patients outweigh residual risks
Design and Construction Requirements
- Chemical, physical, and biological properties — materials compatible with intended use; biocompatibility per ISO 10993
- Infection and microbial contamination — design minimises contamination risk; sterile devices meet appropriate standards
- Construction and environmental properties — performance maintained in expected use conditions
- Devices with measuring functions — accuracy and precision requirements
- Protection against radiation — radiation-emitting devices comply with applicable standards
- Active devices — electrical safety (IEC 60601 series), software reliability (IEC 62304)
Risk Management — ISO 14971
All Class B/C/D devices must have a documented risk management process following ISO 14971. The dossier includes a risk management summary demonstrating:
- Hazards identified and risks estimated
- Risk control measures implemented
- Residual risks evaluated and acceptable
- Benefit-risk analysis confirms benefits outweigh risks
Biocompatibility — ISO 10993
For devices in contact with the human body, biological evaluation per the ISO 10993 series is expected:
- ISO 10993-1 — Biological evaluation: Evaluation and testing within a risk management process
- Testing requirements depend on nature, duration, and degree of patient contact
Grouping of Devices — BD-Unique
Multiple devices may be covered under a single DGDA application if they meet grouping criteria:
When Devices Can Share a Single Application
| Condition | Requirement |
|---|---|
| Same manufacturer | All devices in the group must have the same legal manufacturer |
| Same intended purpose | All devices serve the same clinical function |
| Same design principles | Shared design family — not fundamentally different designs |
| Same materials of construction | Core materials consistent across the group |
Examples of valid groups:
- A range of catheters in different sizes (same design, different dimensions)
- Surgical scissors in different lengths/configurations
- A system consisting of a device plus its dedicated accessories
Systems and Procedure Packs
A system (multiple devices working together as an integrated unit) or a procedure pack (multiple devices packaged together for a specific clinical procedure) may qualify for a single application. Document the functional relationship between components.
Confirm eligibility with the DGDA before preparing a grouped application — not all multi-product submissions qualify.
Price Controls — DGDA Price-Fixing Role — BD-Unique
The DGDA has statutory authority to fix the prices of registered drugs and medical devices. This means:
- A registered device's selling price in Bangladesh is subject to DGDA approval
- Price changes during the 5-year registration period may require DGDA notification or prior approval
- ARs must ensure they do not sell above the DGDA-approved price
- Violations of price-fixing orders can result in enforcement action
Practical guidance: Discuss pricing requirements with your AR and the DGDA when preparing your registration. Budget for the possibility that the DGDA may set a price lower than desired commercial pricing.
DGDA Fee Schedule
DGDA charges fees for:
- Registration applications (by class)
- Import licence applications and renewals
- Manufacturing licence applications and renewals
- Certificate issuance (FSC, GMP certificate, CPP, export licence)
Confirm current fees directly with the DGDA — fees may change. The current schedule is available from the DGDA website or office.
Official Source
All documents: DGDA Official Website — www.dgda.gov.bd
DGDA reviewers check documents carefully. Ensure all certificates are current, signatures and stamps are present, translations are certified, and information is consistent across all dossier documents.
Examples:
- A manufacturer produces three models of non-invasive blood pressure monitors using the same transducer design and materials. All three can be grouped under one application if they share the same intended clinical purpose (non-invasive monitoring) and differ only in display size or wireless connectivity—peripheral differences that do not affect safety or performance.
- A manufacturer cannot group a Class B diagnostic device with a Class D implantable device under one application, even if manufactured by the same company, because they have fundamentally different risk profiles and clinical purposes.
After the table row with 'Same materials of construction | Core materials consistent across the group', add a row: 'Examples | Blood pressure monitors with identical cuff designs and sensing electronics manufactured together; diagnostic test kits using the same reagent format but for different analytes (e.g., glucose, cholesterol if using identical strips)'