Device Classification and Regulatory Pathways
Understanding Device Classifications and Regulatory Requirements in Bangladesh
Regulatory Authority
Medical devices sold in Bangladesh are regulated by the Directorate General of Drug Administration (DGDA). The DGDA operates under the Ministry of Health and Family Welfare and oversees medical devices, pharmaceuticals, and health products. Pure Global can assist with Bangladesh medical device registration and local representation, ensuring DGDA approval to sell in the Bangladeshi market.
Classification
In Bangladesh, medical devices are stratified into categories A through D, reflecting a progression in risk levels. This classification guides the regulatory pathway for each device, influencing the registration and approval process.
Key Requirements
For market entry, foreign manufacturers are required to:
- Appoint an Authorized Representative in Bangladesh.
- Submit a comprehensive registration dossier to the DGDA, detailing the device's classification and demonstrating compliance with the regulatory requirements.
