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Guidance & Resources

DGDA · ISO standards · QMS · Grouping · Price controls

Official DGDA Documents​

DocumentContentWhere to Find
DGDA Registration Guidelines for Medical DevicesFull registration procedure, Annexure 1 (classification rules), documentation checklistswww.dgda.gov.bd
Application formsDGDA prescribed forms for registration, import licence, manufacturing licenceDGDA website / DGDA office
DGDA fee scheduleOfficial fees payable for registration, licensing, and certificatesDGDA website
GHTF guidance documentsAdopted by DGDA as basis for classification and registration requirementsDGDA 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​

ConditionRequirement
Same manufacturerAll devices in the group must have the same legal manufacturer
Same intended purposeAll devices serve the same clinical function
Same design principlesShared design family — not fundamentally different designs
Same materials of constructionCore 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:

  1. A registered device's selling price in Bangladesh is subject to DGDA approval
  2. Price changes during the 5-year registration period may require DGDA notification or prior approval
  3. ARs must ensure they do not sell above the DGDA-approved price
  4. 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

Documentation quality matters

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.