Unlocking the Potential of Bangladesh's Growing Healthcare Market

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.

Device Classification and Regulatory Pathways

Understanding Device Classifications and Regulatory Requirements in Bangladesh

Regulatory Authority

The Directorate General of Drug Administration (DGDA), under the Ministry of Health and Family Welfare, is the regulatory authority overseeing the registration, importation, and approval of medical devices and IVDs in Bangladesh. The DGDA enforces a classification system for medical devices into four categories (A, B, C, and D) based on risk, as outlined in the Bangladesh Gazette for Medical Devices.

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.
How We Can Help

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.

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