Regulatory Open Forum

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  • 1.  Saudi Arabia Registration

    Posted 04-Oct-2018 13:58
    Anyone have experience with Saudi Arabia registration?  Specifically, I am trying to verify if one has a Saudi Arabia registration that expired, can it still be renewed in some way or does one have to essentially do a new registration?

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    Steven Murray RAC
    Regulatory Affairs Specialist
    Tucson AZ
    United States
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  • 2.  RE: Saudi Arabia Registration

    Posted 05-Oct-2018 09:54
    Saudi Arabia has one month grace period for certificates that are expired to apply for renewal. If a certificate has expired more than a month, you will have to apply a new registration.

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    Qianqian Zhu RAC
    Atlanta GA
    United States
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    Original Message


  • 3.  RE: Saudi Arabia Registration

    Posted 05-Oct-2018 14:10
    we have over 5 years experiance in product registartion in Saudi. If its already expired you have to redo it but if your have the info ready you might be able to expedite the process. do you know if company and product listing and registartion with the KFDA is still valid?

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    Benjamin Arazy
    President and C.E.O
    Vancouver BC
    Canada
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    Original Message


  • 4.  RE: Saudi Arabia Registration

    Posted 05-Oct-2018 15:27
    Hi Steven,

    I've done some registration work in Saudi and my initial reaction is that you will need to re-register as a new unfortunately. I'm not 100% sure, so one idea is that you check with your distributor if you work with one. Not exactly the answer your looking for, but hopefully somewhat helpful. 


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    Denise Kelly RAC
    Senior Regulatory Affairs Specialist
    [Guilford] CT
    United States
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    Original Message


  • 5.  RE: Saudi Arabia Registration

    Posted 10-Oct-2018 22:53
    Dear Steven , 

    I'm afraid you need to resubmit the dossier as a new file , as company needs to submit the renewal dossier 6 months before expiry . 
    I would recommend that your Saudi agent to contact SFDA for advise with justification why renewal dossier was not submitted on time .

    Regards 
    Hakima

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    Hakima Hoseh
    Regulatory Affairs compliance S manager
    Amman
    Jordan
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    Original Message


  • 6.  RE: Saudi Arabia Registration

    Posted 11-Oct-2018 00:02
    Dear Steven , 

    I have return back to guidelines , please ask for an appointment with SFDA portal and submit the dossier for renewal ,

    Regards 

    Hakima

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    Hakima Hoseh
    Regulatory Affairs compliance S manager
    Amman
    Jordan
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    Original Message


  • 7.  RE: Saudi Arabia Registration

    Posted 12-Oct-2018 03:13

    Hi Steven,

    there are 2 steps for medical device registration and/or renewal in Saudi Arabia -

    • Step 1/ SFDA Authorized License Representative for Legal Manufacturer, where licensed entity can be your local distributor, local regulatory consultant, or local, scientific office (https://mdel.sfda.gov.sa/
    • Step 2/ Medical Device Marketing Authorization (MDMA) for a medical device or bundle of medical devices (https://mdma.sfda.gov.sa/

    Both can be re-new online at aforementioned links after payment of implicated fees.

    In case your medical device is a Class I non-sterile and non-measuring, an online enlistment procedure (Medical Device National Registry) through your local distributor/ importer is now feasible at https://mdnr.sfda.gov.sa. It usually takes around 10 business days for completion.

    Hope this helps!



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    Best Regards,
    Dr. Fatima Z Abu Zanat
    Regional Regulatory Affairs & Scientific Office Manager
    Mundipharma
    Dubai, United Arab Emirates
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    Original Message


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