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.
Bangladesh’s medical devices market will reach $820M by 2025 (13% CAGR), and the IVD market$68.5M by 2029 (6.27% CAGR). Growth is driven by rising healthcare spending, high import dependence (85%), and an aging population (5.2% 65+ in 2021).
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.
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.
For market entry, foreign manufacturers are required to:
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.
Class B, C, and D must submit proof of a certified quality management system in the form of an ISO 13485 certificate.
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.
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.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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