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    IMD Registration Guideline

    Uploaded by

    marco giu
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    IMD Registration Guideline

    Uploaded by

    marco giu
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    IMD Registration Guideline qatar

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    © © All Rights Reserved

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    IMD Registration Guideline qatar

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    8 views2 pages

    IMD Registration Guideline

    Uploaded by

    marco giu
    IMD Registration Guideline qatar

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    Implantable Medical Devices

    Registration Guideline
    Health Facilities Licensing and Accreditation Department

    Definition
    Medical devices that are either partly or totally introduced, surgically or medically, into the human body
    and are intended to remain there after the procedure for more than 4 weeks for diagnostic or therapeutic
    purposes are classified as implantable medical devices. IMDs include devices that are fixators, hydraulic,
    battery-powered, or biodegradable; some examples are but not limited to pacemakers, implantable
    insulin pumps, implantable cardiac defibrillators (ICDs), coronary stents, intraocular lenses, screws and
    plates of orthopedics, and breast implants.

    Application Procedure
    • All facilities (medical facilities/local agents/distributors) in the State of Qatar are to register
    implantable medical devices with the Implanted Medical Devices Committee and obtain a Certificate
    of Registration Approval before importing an IMD into Qatar.

    • To apply for registration, send an email to the IMD Committee address


    (implantedmdcommittee@moph.gov.qa) with filled Implantable Medical Device Registration
    Application Form and all the required supporting documents.

    Notes
    • Any additional technical or clinical documentation must be provided at the request of the
    Committee.
    • Original documents must be presented upon request.
    • Documents presented must be in Arabic or English (documents in other languages must be
    translated and presented along with a copy of the original documents).
    • The IMD Committee does not issue approvals directly to international manufacturers. IMDs are
    required to be registered by local facilities (suppliers or medical facilities) in the State of Qatar.
    Implantable Medical Devices Registration
    Required Documents
    Manufacturer/Local Facility Related Documents:
    1. Filled IMD Registration Application Form.
    2. Registration certificate of the manufacturer(s).
    3. Valid registration certificate of the applicant facility.
    4. A valid Free Sale Certificate issued by the competent authorities in the country of origin attested
    by Qatari MoFA.
    5. Authorization letter/Contract from the manufacturer for the local facility with clear details of
    service validity and responsibilities.
    6. Declaration from the manufacturer stating that IMD proposed for registration is not facing any
    legal proceedings, bans, or suspended use in any country and undertaking that in the event of any
    of the above-mentioned proceedings against registered IMDs, the manufacturer shall inform the
    IMD Committee within 2 weeks.
    7. Declaration from the manufacturer, stating in case of termination of the local facility or local
    facility unable to serve then the manufacturer will provide direct support.
    IMD Related Documents:
    8. Notarized CE or FDA certificates for the product from the country of origin.
    9. Free Sale Certificate (FSC) for the product from the country of origin.
    10. Post-marketing surveillance Plan.
    11. Product information (Finished Product Specifications), including description, design, sizes, models,
    accessories, uses, side-effects, warnings, precautions, brochures, and manuals.
    12. Laboratory analysis report.
    13. Safety datasheet.
    Additional Documents:
    14. Description and technical details of any accessories/kits needed to implant/manage the IMDs (if
    applicable).
    15. Any specialized training/certification needed by clinical professionals to administer the IMD and
    certification for the representative who will provide clinical and technical assistance locally (if
    applicable).

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