Bangladesh Product Registration & Certification
Important Notes
- DGDA Registration: All pharmaceuticals, medical devices, and cosmetics 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): All registered drugs are under government price control, requiring MRP registration with DGDA, and selling price cannot exceed it. Price control for devices is looser but tightening.
- Labeling & Language Requirements: Product labels and instructions must be in Bengali (Bangla). Additional English information is allowed, but core information (name, dosage, 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 pharmacopoeial standards.
Bangladesh Specific Requirements
- Generic-Dominated Large Market with Affordability Focus: As a Least Developed Country with TRIPS waiver, it has a strong local generic industry. The market is extremely price-sensitive, dominated by branded generics and essential medicines.
- Dual Public-Private & Rapidly Growing Healthcare: The public system provides basic care but is resource-constrained; private hospitals, clinics, and pharmacies are growing rapidly with urbanization, serving as the main channel for mid-to-high-end products.
- Dependence on International Aid & Procurement Projects: Health aid programs from international organizations (e.g., Global Fund, UNICEF, World Bank) are key purchasers for high-end drugs and specific devices, requiring eligibility for their procurement.
- Local Pharma as Strong Partner & Competitor: Local pharmaceutical firms are not only major suppliers of low-cost generics but also increasingly becoming contract manufacturers or licensing partners for international companies.
- Regulatory Capacity Building & Gradual Stringency: DGDA is working to strengthen regulatory capacity, 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 registration approval, import licensing, quality supervision, and market regulation of medical devices, pharmaceuticals, and health products. Operates as the primary health product regulatory authority under the Bangladesh Ministry of Health and Family Welfare.
BSTI
Bangladesh Standards and Testing Institution
Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Bangladesh national standards
M/o Health
Ministry of Health and Family Welfare Bangladesh
Responsible for developing national health policies, pharmaceutical 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
Cosmetics Registration
Regulatory Requirements
- Cosmetic Registration Certificate
- Ingredient Safety Assessment Report
- English/Bengali Bilingual Labeling
- Good Manufacturing Practice Certification
- Product Information File
- Microbiological Test Reports
- Stability Study Data
- BSTI Mandatory Certification (for specific products)
- Prohibited Ingredients Compliance Proof
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Local Agent Appointment
- Registration Application Submission
- BSTI Certification Acquisition
Registration Timeline
8-15 months
Official Fees
BDT 100,000 - 800,000
Service Fees
$10,000 - $25,000
Regulatory System Overview
DGDA
Directorate General of Drug Administration Bangladesh
Responsible for registration approval, import licensing, quality supervision, and market regulation of medical devices, pharmaceuticals, and health products. Operates as the primary health product regulatory authority under the Bangladesh Ministry of Health and Family Welfare.
BSTI
Bangladesh Standards and Testing Institution
Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Bangladesh national standards
M/o Health
Ministry of Health and Family Welfare Bangladesh
Responsible for developing national health policies, pharmaceutical regulatory frameworks, and public health standards, overseeing DGDA operations and enforcement
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Bangladesh cosmetic regulations
Safety Assessment Report
Prepare product safety assessment report and technical documentation
Local Agent Appointment
Appoint authorized agent in Bangladesh responsible for registration affairs
Registration Application Submission
Submit cosmetic registration application to relevant regulatory authorities
BSTI Certification
Obtain mandatory certification from Bangladesh Standards and Testing Institution for specific product categories
Health Products Registration
Regulatory Requirements
- Health Product Registration Certificate
- Ingredient Safety and Quality Proof
- English/Bengali Bilingual Labeling
- Good Manufacturing Practice Certification
- Scientific Basis for Efficacy Claims
- Stability Study Data
- Heavy Metals and Contaminants Testing
- Microbiological Test Reports
- Traditional Use Evidence (if applicable)
Main Process
- Product Classification Confirmation
- Technical Documentation Preparation
- Local Agent Appointment
- Registration Application Submission
- Sample Testing Completion
Registration Timeline
10-18 months
Official Fees
BDT 150,000 - 1,200,000
Service Fees
$12,000 - $32,000
Regulatory System Overview
DGDA
Directorate General of Drug Administration Bangladesh
Responsible for registration approval, import licensing, quality supervision, and market regulation of medical devices, pharmaceuticals, and health products. Operates as the primary health product regulatory authority under the Bangladesh Ministry of Health and Family Welfare.
BSTI
Bangladesh Standards and Testing Institution
Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Bangladesh national standards
M/o Health
Ministry of Health and Family Welfare Bangladesh
Responsible for developing national health policies, pharmaceutical regulatory frameworks, and public health standards, overseeing DGDA operations and enforcement
Health Products Registration Process
Product Classification Confirmation
Confirm product falls under health products category, determine applicable registration classification
Technical Documentation Preparation
Prepare complete technical documentation including ingredient analysis, safety evidence, efficacy proof
Local Agent Appointment
Appoint authorized agent in Bangladesh with appropriate qualifications
Registration Application Submission
Submit health product registration application to DGDA
Local Testing
Complete mandatory product quality testing in Bangladesh accredited laboratories