DGDA Bangladesh Medical Device Registration

Pure Global facilitates DGDA Bangladesh medical device registration, providing essential services to help international manufacturers navigate the regulatory landscape in Bangladesh. With a population exceeding 170 million and a rapidly growing healthcare sector, Bangladesh represents a significant market opportunity, particularly as it relies heavily on imported medical devices.

The regulatory oversight in Bangladesh is managed by the Directorate General of Drug Administration (DGDA), which categorizes medical devices into four classes—A through D—based on increasing risk levels. This classification is crucial as it determines the specific regulatory requirements and the pathway each device must follow for registration and approval in the Bangladeshi market.

To enter the market, foreign manufacturers must appoint an Authorized Representative in Bangladesh. They are also required to submit a comprehensive registration dossier to the DGDA. This dossier should detail the device's classification and demonstrate compliance with all relevant regulatory standards.

Key steps involved in the registration process include:

Classification and Grouping: Assistance in accurately classifying and grouping medical devices according to the DGDA’s categories to identify the correct regulatory pathway.
Technical Dossier Preparation: Compilation of all necessary documentation required for DGDA registration. This includes detailed descriptions of the device, evidence of safety and efficacy, and compliance with regulatory standards.
Authorized Representation: Acting as the manufacturer's Authorized Representative in Bangladesh, managing the registration process, and ensuring adherence to post-market regulatory obligations.
Pure Global leverages its extensive expertise and a global network of clinical labs and regulatory databases to provide tailored support that accelerates market entry and ensures compliance with Bangladeshi regulations. This comprehensive approach helps international medical device companies successfully introduce their products to the Bangladeshi market, capitalizing on the growing demand for advanced healthcare solutions.

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DGDA Bangladesh Medical
Device Registration

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ha burgeoning population of ver 170 milion and a rap expanding
healthcare industry, Bangladesh presents a promisingopportunty for
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coupled with a heavy relance on imported medical devices postions
Bangladesh as an tracto market or international manufacturers.

2. Understanding Device
Classifications And
Regulatory Requirements In
Bangladesh

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Classification In Bangladesh, medical devices are stratified into categories A through D.
reflecting a progression in risk eves. This cassifcation guides the
regulatory pathway for each device. infuencing the registration and
approval process.

Key Requirements For market entr foreign manufacturers are require to:
+ Appoint an Authorized Representative n Bangladesh,
+ Submit comprehensive registration dossier tothe DGDA,deallngihe
devices cassation and demonstrating compliance wih the regulatory
requirements.

3. Tailored Support For
Market Entry

Our expertise and services are designed to facilitate your
successful market entry into Bangladesh:

Y. Assistance with the classification and grouping of your
products to outin 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

4. We Provide Access To
28+ Markets Worldwide

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