Regulatory Open Forum

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  • 1.  Lebanon Medical device regulations

    Posted 14 days ago

    Hi RAPS Members,

    Am struggling with lebanon main regulation which i have to look for for medical devices, please help.

    i am getting info. little bit from 3rd party sources only.

    only 1 official document found i.e

    Resolution No. 1/455

    Regulating the introduction and use of various medical materials

    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/listofRegisteredimplentableMedicalDevices/Karar455-2013.pdf



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    Sushma Polisetty
    Lead Consultant
    Bengaluru
    India
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  • 2.  RE: Lebanon Medical device regulations

    Posted 10 days ago

    Dear Sushma,

    According to my research only implantable devices are required to be registered in Lebanon.  This information was correct as of January 2024.

    REGULATORY AUTHORITY: The two bodies regulating medical device registration in Lebanon are The Drug Import and Export Department and The Sanitary Engineering Service, which both act under the Ministry of Public Health.

    LICENSE VALIDITY: The registration process is an import permit and must be performed with every shipment. 

    AUTHORIZED REPRESENTATIVE: The local importer will be considered the authorized representative for the foreign manufacturer.

    ADDITIONAL INFORMATION: Currently, only implantable devices are required to be registered.

    Regards,



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    D Michelle Williams
    VP - Operations
    United States
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