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 that meet DGDA Bangladesh medical device registration requirements.
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.
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.
Frequently
Asked Questions
What are the medical device quality management system (QMS) requirements in Bangladesh?
Class B, C, and D must submit proof of a certified quality management system in the form of an ISO 13485 certificate.
How long is my medical device registration in Bangladesh valid?
Class A device registrations do not expire. Class B, C, and D devices are valid for five years and must be renewed to continue distribution.
How long does registration approval take in Bangladesh?
The average registration application receives a decision from DGDA in 4-6 months. The review is a two-step process. The first is completeness review, which DGDA performs quarterly. The second is a final and more thorough review of all submitted documentation.
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