Bangladesh Medical Device Registration
Important Notes
- DGDA Registration: All medical devices must be registered with the Directorate General of Drug Administration to obtain a Registration Certificate for import, manufacture, or sale.
- Local Authorized Agent or Importer: Foreign manufacturers must appoint a locally registered Bangladeshi company as the authorized agent or importer to submit the registration application and assume legal responsibility.
- Technical Documentation & Reference Approvals: English technical documentation is required. DGDA heavily references approvals from WHO prequalification, India, UK, and other specified reference countries during review.
- Price Control & Maximum Retail Price (MRP): Registered medical devices may be subject to government price monitoring, requiring MRP registration with DGDA, and selling price cannot exceed it.
- Labeling & Language Requirements: Medical device labels and instructions must be in Bengali (Bangla). Additional English information is allowed, but core information (name, warnings) must be in Bengali.
- Quality Control & Sample Testing: Registration typically requires sample submission to DGDA-designated labs for testing or providing a Certificate of Analysis meeting applicable standards.
Bangladesh Specific Requirements
- Large Market with Affordability Focus: As a Least Developed Country, the medical device market is extremely price-sensitive, dominated by essential and cost-effective medical devices.
- Dual Public-Private & Rapidly Growing Healthcare: The public system provides basic care but is resource-constrained; private hospitals, clinics, and diagnostic centers are growing rapidly with urbanization, serving as the main channel for mid-to-high-end medical devices.
- Dependence on International Aid & Procurement Projects: Health aid programs from international organizations (e.g., Global Fund, UNICEF, World Bank) are key purchasers for specific medical devices, requiring eligibility for their procurement.
- Local Distributors as Strong Partners: Local medical device distributors are not only major suppliers but also increasingly becoming service and maintenance partners for international companies.
- Regulatory Capacity Building & Gradual Stringency: DGDA is working to strengthen regulatory capacity for medical devices, with processes gradually standardizing, but reliance on international reference approvals remains a key short-term feature.
Medical Devices Registration
Regulatory Requirements
- Medical Device Import Registration Certificate
- Classification Management by Risk Level (Class A, B, C, D)
- Complete Technical Documentation and Test Reports
- Quality Management System Certificate (ISO 13485)
- English/Bengali Bilingual Labeling
- Free Sale Certificate
- Certificate of Origin
- GMP Certificate
- Stability Study Data
- Bangladesh Local Agent Agreement
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Agent Appointment
- DGDA Application Submission
- Sample Testing Completion
- Registration Certificate Acquisition
Registration Timeline
12-24 months
Official Fees
BDT 200,000 - 5,000,000
Service Fees
$18,000 - $55,000
Regulatory System Overview
DGDA
Directorate General of Drug Administration Bangladesh
Responsible for medical device registration approval, import licensing, quality supervision, and market regulation. Operates as the primary medical device regulatory authority under the Bangladesh Ministry of Health and Family Welfare.
BSTI
Bangladesh Standards and Testing Institution
Responsible for developing mandatory medical device standards, conducting product certification and testing, ensuring specific device categories comply with Bangladesh national standards.
M/o Health
Ministry of Health and Family Welfare Bangladesh
Responsible for developing national health policies, medical device regulatory frameworks, and public health standards, overseeing DGDA operations and enforcement.
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to Bangladesh medical device regulations (Class A-D)
Technical Documentation Preparation
Prepare complete technical documentation including product specifications, test reports, quality system certificates
Local Agent Appointment
Appoint authorized agent in Bangladesh responsible for registration and regulatory affairs
DGDA Application Submission
Submit medical device import registration application and all technical documents to DGDA
Sample Testing
Complete mandatory product testing in Bangladesh accredited laboratories