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  • 1.  Registration of IVD in Saudi Arabia

    This message was posted by a user wishing to remain anonymous
    Posted 15-Apr-2019 11:57
    This message was posted by a user wishing to remain anonymous

    Hello everybody,
    Has anyone experience in the registration process of IVDs/MDs in Saudi Arabia?As a legal manufacturer from Europe and working with an authorized representative I was wondering if the need to provide a predefined agreement for authorized representative services to the Saudi Health authorities is really given. The template is coming from the Saudi Health Authorities. Or is it also possible to register the product without signing this agreement template?
    In general, I would appreciate any overview or guidance on the registration process in this country. What are the requirements in particular?
    Thank you for any help.
    M.


  • 2.  RE: Registration of IVD in Saudi Arabia

    Posted 16-Apr-2019 08:31
    Hi,

    For registering Medical Devices in Saudi Arabia, following are the key points for consideration:

    1.Yes, Authorized Representative legalized agreement by Saudi Arabia consulate is mandatory for registration purpose without which you cannot apply via online portal.
    2.The distributor or LTR representing your company has to be based in Saudi Arabia who would apply for MD filing via online portal i.e. MDMA.
    3.The guidelines provides flexibility of filing the product either as per EU regulations or US regulations.
    4.If CE certificate is available then they prefer to have labeling with address exactly as mentioned on CE certificate i.e. both office as well as factory address.

    Regards

    Purvi 


    ------------------------------
    PURVI GORADIA
    Manager Regulatory Affairs
    Mumbai
    India
    ------------------------------

    Original Message


  • 3.  RE: Registration of IVD in Saudi Arabia

    This message was posted by a user wishing to remain anonymous
    Posted 16-Apr-2019 12:35
    This message was posted by a user wishing to remain anonymous

    Hello Purvi,
    Thank you for the information. Our authorized representative provided us with a template of the agreement. This template seems to be provided from the Saudi Consulate itself. Do you kow if adjustments to the template are allowed or will it be invalid as soon as adjustments are made?

    Best regards.
    Original Message


  • 4.  RE: Registration of IVD in Saudi Arabia

    Posted 19-Apr-2019 07:45
    Hi,

    In our case the filled A.R. Agreement was forwarded to us by our distributor in Saudi Arabia. We just had to get it signed and legalized.
    Hence, please get further clarity from your LTR based in Saudi Arabia who should have the correct information.

    Good Luck !!

    ------------------------------
    PURVI GORADIA
    Manager Regulatory Affairs
    Mumbai
    India
    ------------------------------

    Original Message


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