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Medical Devices Registration in Bangladesh

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    Government Authority (DGDA)

    In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards. DGDA’s role is pivotal in ensuring the efficacy and reliability of medical devices through stringent oversight and country registrations.

    Bangladesh Medical Device Regulations

    In Bangladesh, the Bangladesh Drug and Cosmetics Act of 2023, enacted on September 18, serves as the cornerstone of regulatory provisions governing medical devices and pharmaceuticals. This legislation addresses crucial aspects such as manufacturing, importing, distributing, and selling medical devices, primarily focusing on ensuring adherence to quality and safety standards.

    One significant requirement outlined in the Bangladesh Drug and Cosmetics Act is the necessity for medical device registration. Manufacturers and importers must obtain country registrations from the appropriate regulatory authorities. These registrations serve as official endorsements, affirming compliance with the regulatory framework and granting authorization for market entry and distribution.

    Ensuring compliance with medical devices registration requirements is paramount for businesses in Bangladesh’s healthcare sector. By adhering to these regulations, companies demonstrate their commitment to upholding quality and safety standards, thereby fostering trust among consumers and stakeholders alike.

    Medical Device Registration

    Medical Device Status

    As of September 18, 2023, the Government of Bangladesh introduced the Drug and Cosmetics Act, 2023, outlining regulations for medical devices, IVD reagents, and software. This act expands the definition of medical devices, now encompassing software under drug regulations

    According to the Drugs and Cosmetics Act, 2023, a medical device is defined as follows:

    “Medical device” encompasses:

    (a) Various devices such as instruments, apparatus, implements, machines, appliances, implants, diagnostic reagents (in vitro, in vivo, and silico reagents), software, or related materials. These are used either independently or in combination for specific purposes, including:

    (i) Diagnosis, prevention, monitoring, treatment, or alleviation of diseases or disorders;

    (ii) Diagnosis, monitoring, treatment, alleviation, or assistance for injuries or disabilities;

    (iii) Investigation, replacement, modification, or support of anatomy or physiological processes;

    (iv) Supporting or sustaining life;

    (v) Conception control or medical device disinfection;

    (vi) Providing information through examining and analyzing samples collected from human or animal bodies, unaffected by pharmacological, immunological, or metabolic actions.

    (b) Additionally, any device or diagnostic reagent declared by the government, through notification in the Official Gazette, for this Act.

    This comprehensive definition broadens the scope of medical devices under the regulatory purview, ensuring the safety and efficacy of products intended for use in Bangladesh. It underscores the importance of adherence to regulations for manufacturers seeking medical devices registration in Bangladesh.

    Medical Device Classification System

    International Classification Risk Level
    Class A Low Risk
    Class B Low-Moderate Risk
    Class C High-Moderate Risk
    Class D High Risk
    medical-devices-registration
    Documents Required
    • Option-1: If manufacturer had registered their device in any of the reference countries like EU, USA, Australia, Japan. Then below mentioned documents are enough to proceed Certificate of Free Sale (CFS) and ISO 13485
    • Option-2: If manufacturer doesn’t registered their device in any of the above mentioned countries, then DGDA may ask for additional technical documentation

    *Note- ISO certificate is NOT needed for Class A devices.

    Market Authorization Certificate
    • Class B, C & D Validity – 5 Years and can be renewed in about 2–3 months with a fee of approximately USD 120.
    • Class A Marketing Authorization Certificates does not expire
    Fees Government Processing Fee Approximately: $600

    Medical Device Registration Process

    • Submission of Applications: Begin the medical devices registration process in Bangladesh by applying to the Directorate General of Drug Administration (DGDA).
    • Document Preparation: Ensure all required documents, including product information, technical specifications, and manufacturing details, are prepared accurately.
    • Compliance Assessment: The DGDA conducts a thorough assessment of the submitted documents to ensure compliance with regulatory requirements.
    • Inspection: If deemed necessary, the DGDA may conduct inspections of manufacturing facilities to verify compliance with Good Manufacturing Practices (GMP).
    • Review and Approval: Once all requirements are met, the DGDA reviews the application and grants approval for medical devices registration.
    • Registration Certificate Issuance: Upon approval, the DGDA issues a registration certificate, allowing the medical device to be marketed and distributed in Bangladesh.
    • Renewal: Medical device registrations in Bangladesh typically require renewal after a specified period to maintain compliance with regulatory standards.
    • Post-Market Surveillance: Manufacturers must adhere to post-market surveillance requirements to monitor the safety and performance of registered medical devices in Bangladesh.
    Application Preparation DGDA Timeline
    New Registration 10 Days 4-6 Months
    Renewal 10 Days 2-3 Months
    Change Amendment 10 Days 1 Month

    At Maven, our commitment goes beyond offering exceptional services; we prioritize keeping our clients informed about Bangladesh’s evolving regulatory landscape, especially concerning medical devices registration. Our proactive approach ensures clients stay updated on any pertinent updates, be they changes in compliance standards or approaching registration deadlines.

    We recognize that compliance is just one aspect; our ultimate goal is to empower businesses to reach their full potential globally. By skillfully navigating regulatory frameworks and simplifying the registration process, we enable businesses to seize growth opportunities in Bangladesh and beyond. With Maven’s support, businesses can confidently navigate regulatory compliance and focus on achieving success in the medical device sector and beyond.

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