DGDA Bangladesh Medical Device Registration
With a burgeoning population of over 170 million and a rapidly expanding healthcare industry, Bangladesh presents a promising opportunity for medical device companies. The increasing demand for healthcare services, coupled with a heavy reliance on imported medical devices, positions Bangladesh as an attractive market for international manufacturers.
Understanding Device Classifications and Regulatory Requirements in Bangladesh
Regulatory Authority
Pure Global can assist with Bangladesh medical device registration, 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.
Tailored Support for Market Entry
Our expertise and services are designed to facilitate your successful market entry into Bangladesh:
Assistance with the classification and grouping of your products to outline the regulatory pathway.
Preparation and compilation of the technical dossier required for DGDA registration.
Representation as your Authorized Representative, managing the registration process with the DGDA and ensuring adherence to post-market regulatory obligations.
We Provide Access To 28+ Markets Worldwide
Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.