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Special Device Types

DGDA · Drug and Cosmetics Act 2023 · GHTF principles

Software as a Medical Device (SaMD)​

Software is explicitly included in Bangladesh's medical device definition under the Drug and Cosmetics Act 2023 and is categorised as a "Drug" in Bangladesh's regulatory taxonomy. See Software & IVD Classification for the complete classification framework and documentation requirements.

Key points:

  • Class B/C/D software requires DGDA registration
  • ISO 13485 covering software development is mandatory
  • IEC 62304 software lifecycle documentation is expected
  • An AR must hold the registration

Combination Products — Drug-Device Combinations​

Products combining a device with a pharmaceutical or biological component are classified based on the principal mode of action (PMOA):

Principal ActionRegulated As
Device mechanism (physical, mechanical)Medical device — DGDA registration as device
Pharmacological / biological mechanismPharmaceutical drug — separate DGDA drug registration process

Where the PMOA is genuinely ambiguous (e.g., drug-eluting stents, medicated wound dressings), seek a formal DGDA determination before proceeding. Combination products in the EU MDR or FDA combination product categories should not be assumed to follow the same classification in Bangladesh — seek local determination.

Custom-Made Devices​

Custom-made devices (manufactured specifically for an individual named patient on a clinician's prescription) are generally subject to reduced regulatory requirements:

  • Not required to hold a standard DGDA Class B/C/D registration
  • The manufacturer must maintain technical documentation demonstrating the device meets safety and performance requirements
  • The device cannot be commercially sold under the custom-made exemption — it is manufactured for a specific patient only
  • Mass-produced devices adapted for individual patients do not qualify — standard registration applies

Sterile Devices​

Devices placed on the market in a sterile condition must include sterilisation validation evidence in the registration dossier:

  • Sterilisation process validation in accordance with applicable international standards (ISO 11135 for EO, ISO 11137 for radiation, ISO 17665 for steam)
  • Sterile packaging validation (seal integrity, packaging system performance)
  • Batch release criteria including sterility assurance level (SAL) of 10⁻⁶

Sterile devices are typically classified Class C or D depending on their intended use.

Implantable Devices​

Long-term and permanently implantable devices carry additional requirements:

  • Typically Class C or D — high clinical evidence threshold
  • Biocompatibility testing per ISO 10993 series required (covering all body-contacting materials)
  • Long-term clinical follow-up data typically required
  • Detailed post-market surveillance plan with clear performance monitoring metrics
  • Distribution records to component/lot level for full traceability

Single-Use Devices​

Devices labelled as single-use (not to be reprocessed or reused) must carry:

  • Clear single-use labelling — the international single-use symbol (ISO 7000-1051) is recommended
  • Instructions prohibiting reprocessing
  • Disposal guidance where the device is hazardous or requires special disposal

Bangladesh does not have a specific reprocessing framework for single-use devices. DGDA may take enforcement action where reprocessing creates documented safety risks.

IVD Medical Devices​

IVDs are classified separately under Class A–D IVD rules — see Software & IVD Classification. Key considerations:

  • Class A IVDs: no registration required
  • Class B, C, D IVDs: full DGDA registration required, including performance evaluation data
  • Self-test (lay-user) IVDs are classified higher than equivalent professional-use tests

Export-Only Devices​

Devices manufactured in Bangladesh exclusively for export (not intended for the Bangladesh market) may operate under a different regulatory framework — a manufacturing licence may be required, but DGDA registration of the device for the Bangladesh market is not typically needed. DGDA issues:

  • GMP Certificate confirming manufacturing site compliance — required by most importing countries
  • Free Sale Certificate (FSC) — confirming the device is legally manufactured and marketed; required by importing countries

Contact DGDA for current requirements for export-only manufacturers.

Radiation-Emitting Devices​

Radiation-emitting medical devices (X-ray, CT, nuclear medicine, high-energy lasers) may be subject to additional clearance requirements beyond standard DGDA registration. Contact DGDA and the Bangladesh Atomic Energy Commission (BAEC) to confirm applicable requirements for your device type.