DGDA Registration
Directorate General of Drug Administration
Medical device registration and approval for Bangladesh market entry
Compliance & Quality
Quality Assurance & Import Compliance
We don't hold manufacturing certifications — our partner factories do. Our compliance focus: factory qualification, product verification, and Bangladesh import regulatory management.
Factory Standards We Require
Every partner factory must hold relevant international certifications. We verify these during on-site audits before sourcing.
| Standard | Title | Factory Application |
|---|---|---|
| ISO 13485:2016 | Medical Devices - Quality Management Systems | Required from all partner factories for medical device manufacturing |
| ISO 9001:2015 | Quality Management Systems | Baseline QMS standard for all manufacturing partners |
| ISO 14971:2019 | Application of Risk Management to Medical Devices | Factory risk management for product design and production |
| ISO 10993-1:2018 | Biological Evaluation of Medical Devices | Biocompatibility assessment for patient-contact devices from factories |
| ISO 11607-1:2019 | Packaging for Terminally Sterilized Medical Devices | Sterile barrier validation for applicable factory products |
| IEC 62304:2006+AMD1:2015 | Medical Device Software Life Cycle Processes | Software validation for factory devices with embedded software |
Bangladesh Import Regulatory Management
We handle the complete Bangladesh import regulatory process for medical equipment — from DGDA registration to port release.
Import Permit
Ministry of Commerce / DGDA
Pre-shipment import permit for each medical equipment consignment
Customs Clearance
National Board of Revenue (NBR)
Duty assessment, HS code classification, VAT payment at port of entry
BSTI Standards
Bangladesh Standards & Testing Institution
Compliance with Bangladesh standards for applicable medical equipment
Port Release & Clearance
Chittagong / Mongla Port Authorities
Physical inspection, document verification, and cargo release coordination
Post-Market Compliance
DGDA
Adverse event reporting, field safety corrective actions, license renewal
Our Quality Assurance Framework
Three-layer verification from factory to Bangladesh port — ensuring every product meets specifications before it reaches your facility.
Factory Qualification
On-site facility audits, QMS review, regulatory history check, and sample testing before factory approval.
Incoming Verification
Documentation review, visual inspection, specification verification, and selective testing per AQL standards.
Import Compliance
Bangladesh import licensing, customs clearance, regulatory paperwork, and port release coordination.
Access Compliance Documents
Factory certificates (ISO 13485, CE, FDA, NMPA), product CoA, export documentation, and Bangladesh import paperwork available to qualified clients upon request.