Medical device registration in Bangladesh involves a strict and detailed procedure that must be followed. This process ensures that medical devices meet the necessary safety and quality standards before they can be sold and distributed in the country.
List of required documents for medical device registration in Bangladesh:
- Legal agreement (copy) between the manufacturer & the local agent/distributor (and, Letter of authorization).
- EC Certificate/CE marking/EC Design examination Certificate.
- FSC (Free Sale Certificate) of Manufacturing country-Bangladesh Embassy attested. Original
- FSC of any EU country/USA/Germany/Switzerland/Japan/Australia/UK-Bangladesh Embassy attested (This is required for Class-C & Class-D Med. device).
- Details regarding recall history of past 2 years (duly signed on letter head pad of the manufacturer).
- List of Countries where the product is being marketed. (duly signed on letter head pad of the manufacturer).
- Packaging Materials (empty): Box, Label, IFU, Labeling must reflect the Brand & Manufacturer name, Country of Origin, Mfg. date, Expiry date, Lot no.
- Two (2) pc sample/Colour Catalogue.
- Annexure-3 (will be prepared by Ziva DRA, a prescribed form by DGDA).
Frequently Asked Questions For Medical Device Registration Procedure In Bangladesh
What Is The Procedure For Medical Device Registration In Bangladesh?
The procedure for medical device registration in Bangladesh involves submitting an application to the Directorate General of Drug Administration (DGDA), providing necessary documents such as manufacturing license, product testing reports, and clinical trial data. After evaluation, if all requirements are met, the device is registered and a registration certificate is issued.
How Long Does It Take To Get Medical Device Registration In Bangladesh?
The time required for medical device registration in Bangladesh can vary depending on factors such as the complexity of the device, completeness of the documentation, and the workload of DGDA. Typically, the registration process can take anywhere from 6 to 12 months.
What Are The Documents Required For Medical Device Registration In Bangladesh?
To register a medical device in Bangladesh, you will need to provide various documents such as a manufacturing license, product labeling and insert details, product testing reports, clinical trial data (if applicable), and a power of attorney from the manufacturer.
Detailed information can be obtained from the DGDA guidelines.
Are Clinical Trials Required For Medical Device Registration In Bangladesh?
Yes, clinical trials may be required for certain types of medical devices before they can be registered in Bangladesh. The need for clinical trials will depend on the risk category and intended use of the device. The results of the clinical trials must be included in the registration application.
Conclusion
Navigating the medical device registration procedure in Bangladesh requires careful attention to detail and compliance with the regulatory authorities. From the initial application submission to the assessment and approval process, every step must be meticulously followed. By understanding the guidelines and requirements set forth by the Bangladeshi government, manufacturers and importers can ensure smooth and successful registration of their medical devices.
It is crucial to stay updated with the latest regulations and seek expert assistance when needed to streamline the registration process and ensure compliance with the country’s regulations.