The Bangladesh DGDA certification applies to all medical device products that are sold, distributed, or used in Bangladesh. Whether it is a domestically produced medical device or an imported product, it needs to be certified by the DGDA to ensure that the product meets Bangladesh's standards of quality, safety and effectiveness. The following are the scope of application and related conditions for Bangladesh DGDA certification of medical devices:
Scope of application
Medical devices include, but are not limited to, medical electronic equipment, diagnostic equipment, surgical instruments, medical consumables, in vitro diagnostic reagents and other products.
All medical device products sold, distributed, or used in Bangladesh are required to be DGDA certified.
Conditions and requirements
Product quality and safetyMedical device products must meet the relevant quality and safety standards of Bangladesh, including product design, production process, raw material selection, quality control, etc.
Technical documentation and supporting materialsEnterprises need to submit complete technical documents and supporting materials, including product specifications, technical descriptions, quality control documents, test reports, etc.
Register** or Representative: Enterprises need to choose a Bangladesh registered ** or representative to submit an application for certification to the DGDA on behalf of the enterprise and handle related matters on behalf of the enterprise.
Proof of registration: Medical device products should have obtained the corresponding registration certificate or license in the place of origin or production, and the enterprise needs to provide relevant supporting documents.
On-site inspections:d GDA may arrange on-site inspections to verify that the company's production practices and quality management system meet the requirements of the standard.
Legal ComplianceEnterprises need to comply with relevant laws and regulations in Bangladesh, including medical device regulations and standards.
Application Procedure
Application Submission: The enterprise submits an application for certification to the DGDA through registration**, and submits the application** and relevant supporting materials.
Preliminary review:d GDA will conduct a preliminary review of the application materials, and if there are any non-compliance requirements, the enterprise may be required to supplement or modify the application materials.
On-site inspections:d GDA may arrange on-site inspections to verify that the company's manufacturing practices and quality management system meet the requirements of the standard.
Notification of audit results:d GDA will notify the enterprise of the audit result, and the enterprise that passes the audit will obtain the medical device Bangladesh DGDA certification.
Certification UpdatesThe certification certificate usually has a certain validity period, and the enterprise needs to submit an application for renewal before the certification expires.
To sum up, the scope of application of the Bangladesh DGDA certification for medical devices covers all medical device products that are sold, distributed, or used in Bangladesh. Enterprises need to meet a series of conditions and requirements, go through the application process, and obtain the DGDA certification to ensure product quality and safety, in line with relevant regulations and standards in Bangladesh.