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Import Licensing & Local Representation

DGDA · Mandatory local entity · BD-Unique licensing framework

The Mandatory Local Entity Requirement — BD-Unique​

All DGDA medical device registrations must be held by a Bangladesh-registered entity. Foreign manufacturers cannot register directly. This local entity — the Authorized Representative (AR) — is not optional; it is a fundamental structural requirement of the Bangladesh regulatory framework.

Who Can Be an AR?​

Any Bangladesh-registered company, provided they have:

  • Valid Bangladesh trade licence and tax registration
  • The technical and administrative capacity to fulfil AR obligations
  • Ability to maintain required records and communications with DGDA

Common AR arrangements:

  • The local distributor appointed as AR (most common)
  • A dedicated regulatory affairs service company acting as AR
  • A locally registered subsidiary of the foreign manufacturer

AR vs Importer — The Distinction​

RoleFunction
ARHolds the DGDA registration licence; corresponds with DGDA; responsible for regulatory compliance
ImporterPhysically imports the goods and holds the DGDA import licence; handles customs clearance

These can be the same entity or different entities. A manufacturer may appoint one AR (who holds the registration) and multiple importers/distributors (who handle logistics and distribution). The AR retains regulatory accountability regardless of the physical distribution arrangements.

AR Obligations Summary​

  • Submit and hold DGDA registration certificates
  • Correspond with DGDA on all regulatory matters
  • Manage post-market vigilance (adverse event reporting, FSCAs)
  • Comply with DGDA pricing requirements
  • Maintain distribution records for traceability
  • Cooperate with DGDA inspections and requests

DGDA Import Licence — BD-Unique​

To commercially import registered Class B/C/D medical devices into Bangladesh, the relevant entity must hold a DGDA import licence.

Import Licence Application​

Submit to the DGDA:

  • Company details and trade licence
  • Details of the registered device(s) to be imported
  • AR appointment documentation (confirming the registration exists)
  • Proof of DGDA registration of the device

Customs Clearance​

Once a valid import licence is held:

  • Import shipments are cleared through Bangladesh customs using the import licence number
  • Bangladesh Customs may inspect shipments; ensure labelling and documentation are accurate
  • All imported devices must match the registration (model, specifications, labelling)

Import Restrictions​

The DGDA maintains oversight of what may be imported. Devices not registered (Class B/C/D) or not meeting labelling requirements may be seized at customs. Ensure registration is valid before scheduling import shipments.

Manufacturing Licence — For Local Manufacturers​

Bangladesh-based manufacturers of Class B/C/D medical devices must obtain a DGDA manufacturing licence covering their production facility.

Manufacturing Licence Process​

  1. GMP inspection — DGDA inspectors assess the facility against GMP requirements
  2. Documentation review — quality manual, SOPs, batch records systems
  3. Licence issuance — once GMP compliance is confirmed, the manufacturing licence is issued
  4. Periodic renewal — licences are subject to renewal and may require re-inspection

GMP Standards​

Bangladesh's GMP requirements for medical device manufacturing are broadly aligned with ISO 13485. Manufacturers should maintain an ISO 13485-certified QMS covering all manufacturing activities.

DGDA Certificates Issued — BD-Unique​

The DGDA issues several official certificates relevant to medical device manufacturers and the export of Bangladesh-manufactured devices:

Free Sale Certificate (FSC)​

Confirms that a specific medical device is legally marketed in Bangladesh. This certificate is commonly required by importing countries when Bangladesh-manufactured devices are exported. Apply to the DGDA with the DGDA registration documentation and relevant device details.

GMP Certificate​

Confirms that a manufacturing facility in Bangladesh meets GMP standards. Required by many importing countries as part of their own registration requirements. Issued following DGDA factory inspection.

Certificate of Pharmaceutical Products (CPP)​

A WHO-format certificate for pharmaceutical products (and sometimes devices) confirming regulatory status. May be required by certain importing countries.

Export Licence​

For certain device categories, an export licence from the DGDA may be required before the device can be shipped out of Bangladesh.

Enforcement and Market Surveillance — BD-Unique​

The DGDA conducts market surveillance to ensure devices on the Bangladesh market are properly registered and meet labelling and quality requirements.

Enforcement Actions​

ActionDGDA Authority
InspectionsDGDA may inspect establishments, warehouses, and facilities
SeizureNon-compliant, unregistered, or substandard devices may be seized
CondemnationSeized devices may be condemned and destroyed
Licence suspension/cancellationDGDA may suspend or cancel import/manufacturing licences
Drug Court prosecutionSerious violations prosecuted in Drug Courts — fines and imprisonment

Priority Enforcement Areas​

  • Devices being distributed without DGDA registration (Class B/C/D)
  • Devices with misleading or non-compliant labelling
  • Importation without a valid import licence
  • Counterfeit or substandard devices entering the supply chain