DGDA Inspections
DGDA · Manufacturing licence · Market surveillance · GMP compliance
Overview
The DGDA inspects establishments involved in medical device manufacturing, importing, and distribution in Bangladesh. Inspections are conducted to verify GMP compliance (manufacturers), storage and distribution practices (importers/ARs), and overall regulatory compliance.
Types of Inspections
| Type | Who | Trigger |
|---|---|---|
| Pre-licence GMP inspection | Domestic manufacturers | Part of manufacturing licence application |
| Periodic GMP reinspection | Domestic manufacturers | Licence renewal or scheduled programme |
| Market surveillance inspection | ARs, importers, distributors | Routine monitoring |
| Complaint/event-triggered inspection | Any establishment | Following adverse event, complaint, or safety concern |
| Import spot checks | Importers | At border / port of entry |
Manufacturing Licence Inspections — For Local Manufacturers
Before a manufacturing licence is granted, DGDA inspectors conduct an on-site inspection assessing:
- Facility design and environmental controls
- Equipment qualification and maintenance records
- Production and process controls
- Document control and batch records
- Personnel training and qualification records
- QMS implementation (ISO 13485 or equivalent)
- Complaint handling and CAPA systems
A manufacturing licence is only issued once the facility demonstrates satisfactory GMP compliance. Critical deficiencies must be remediated before re-inspection.
Market Surveillance — Importers and ARs
DGDA conducts market surveillance of imported devices across the supply chain. Inspectors may:
- Inspect AR and importer premises for storage condition compliance
- Review distribution records and traceability documentation
- Verify DGDA registration of products being distributed
- Check labelling compliance of products in the distribution chain
- Request complaint handling records and adverse event report documentation
Responding to Inspection Findings
When DGDA inspectors identify deficiencies:
- A Notice of Non-Compliance or similar formal finding is issued
- The establishment must prepare a CAPA response within the specified timeframe
- DGDA may conduct a follow-up inspection to verify implementation
- Unresolved critical findings may lead to:
- Suspension of manufacturing or import licence
- Revocation of DGDA registration
- Seizure of non-compliant products
- Drug Court prosecution for serious violations
Preparing for Inspection
Key preparation steps:
- Maintain complete, organised records of all DGDA registrations and certificates
- Keep distribution records current and readily accessible
- Ensure all products being distributed are covered by valid DGDA registrations
- Train staff on inspection cooperation procedures — inspectors should be welcomed and directed to the QMS documentation owner
- Conduct regular internal audits to identify and address gaps before a DGDA inspection
Border Inspections — BD-Unique
Bangladesh Customs, coordinated with DGDA, may inspect imported medical device shipments at ports of entry. Importers should ensure:
- Import licence number is clearly stated in customs documentation
- Labelling of imported shipments matches the DGDA registration
- Certificates (ISO 13485, FSC) are available on request
- Lot/batch numbers of imported shipments are recorded for traceability
Devices found to be unregistered, mislabelled, or non-compliant at the border may be seized and/or returned to the shipper.