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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​

AR vs Importer — The Distinction

RoleFunction
ARHolds the DGDA registration licence; submits the registration application; corresponds with DGDA on all regulatory matters; responsible for regulatory compliance and post-market vigilance
ImporterHolds a separate DGDA import licence; physically imports goods; handles customs clearance; must be authorised by the AR

These can be the same entity or different entities:

  • Single entity model: The AR is also the importer (most common, especially for distributors appointed as AR)
  • Separate entity model: The AR holds the registration but delegates importation to one or more licensed importers

In either case, the AR retains regulatory accountability to the DGDA regardless of physical distribution arrangements. Importers must always operate under the authority of a registered AR.

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

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:

  • DGDA registration documentation (proof of valid registration)
  • Device specifications and labelling samples
  • Certificate request form available from DGDA

Processing typically takes 10–15 working days. The FSC is valid for one year from issue and must be renewed if needed for continued exports.