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  • 1.  Saudi Arabia New Regulations - TFA for Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 05-Mar-2021 14:59
    This message was posted by a user wishing to remain anonymous

    Dear colleagues,

    I'm facing some challenges with new registrations requirements in Saudi Arabia for medical devices.
    According to the official information, the transition is July 2021 for new registrations and July 2022 for renewals. Nevertheless, my local distributor is already requesting to submit our renewals according to new regulations (TFA). 
    Also, our class I renewal was requested to provide full technical documentation instead of the listing requirements.

    Has anyone experienced this? Could be the case that my distributor is under a pilot phase?

    Thanks.

    Emilia


  • 2.  RE: Saudi Arabia New Regulations - TFA for Medical Devices

    Posted 08-Mar-2021 03:54
    Dear Emilia,

    Speaking on behalf of a business who has some TFA approvals it appears this is a case of preference of the AR/Distributor operating in Saudi at the moment. For example, for a new registration we opted to use the new TFA system (which was akin to a notified body review) yet for our existing license renewals we remained under the existing process. There is no requirement yet, as you stated, which forces you to opt in for TFA at this time.

    As for the review themselves, as I mentioned our experience suggeests this review was similar to an EU notified body style review, with several rounds of review and a focus on the essential principles. As this path is a 'Technical File Assessment' (TFA) path that is likely why a file is requested if proceeding viat TFA, but our experience has been that technical documentation compliant to MDD 93/42/EEC and/or MDR 2017/745 is suitable for submission and approval.

    Kind Regards,
    Adam Gregory

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    Adam Gregory
    Winsford
    United Kingdom
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    Original Message


  • 3.  RE: Saudi Arabia New Regulations - TFA for Medical Devices

    Posted 12-Mar-2021 03:22
    Hello Emilia,

    If you are applying for a new registration in Saudi Arabia, you might want to provide all TFA route documents because even if it is not fully implemented, SFDA reserves the right to require TFA route documents. Registration renewals on another hand can be done via the GHTF route submitting only the updated/renewed documents.
    If you have a Class I only registration, it is easier to proceed with the Low risk class route (formerly known as MDNR route) which is an abridged route to normal registration process.
    Hope this helps!

    ------------------------------
    Youmna Abboud
    beirut
    Lebanon
    ------------------------------

    Original Message


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