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Registration & Listing of Medical Devices in Saudi Arabia, Iran, Kuwait, UAE, Oman, Jordan, Qatar, Morocco, etc.

  • 1.  Registration & Listing of Medical Devices in Saudi Arabia, Iran, Kuwait, UAE, Oman, Jordan, Qatar, Morocco, etc.

    Posted 21-Apr-2023 12:59

    As a consultant, I am helping a medical device (not IVD) company expand its global presence in Saudi Arabia, Iran, Kuwait, UAE, Oman, Bahrain, Jordan, Qatar, Morocco, Tunisia, Algeria, and Iraq. It's a low-risk device. They have 510(K) clearance, a CE mark and are registered in about 40 countries. They have local partners, and distributors, in each of these markets.
    1.  How much translations of documents should I anticipate per registration?

    2.  What should I anticipate as the top three challenges?

    3  In general, should I be thinking about 2-4 months of work per registration?

    David R Rutledge

    David.Rutledge@GlobalStrategicSolutions.com

    (630) 846-0350 cell



    ------------------------------
    David R Rutledge PharmD, FCCP, FAHA
    President & CEO
    Global Strategic Solutions, LLC
    David.Rutledge@GlobalStrategicSolutions.com
    (630) 846-0350 cell
    Mountain View CA
    United States
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  • 2.  RE: Registration & Listing of Medical Devices in Saudi Arabia, Iran, Kuwait, UAE, Oman, Jordan, Qatar, Morocco, etc.

    This message was posted by a user wishing to remain anonymous
    Posted 25-Apr-2023 08:18
    This message was posted by a user wishing to remain anonymous

    I have done global registrations for over 12+ years and Saudi Arabia was THE HARDEST country EVER for me.
    I literally did back flips (and I'm not a gymnast) when we won the 2023 tender we were waiting for.
    This meant my hardwork finally paid off and the registration was accepted....and of course sales got all the credit...smh...
    The biggest challenge was the SFDA's understanding of the device (intended use/purpose) and unfortunately our distributor was not much help.
    Although Saudi Arabia has its own classification system (MDS-G42), I got this feeling they try to align with both the EU MDR and the USA FDA and this was very confusing.
    The SFDA strictly adheres to a specific format (MD Techincal Documentation) specified in the MDS-REQ1, and I found if some of the elements didn't apply to our device, I had to write justification letters. Make sure to follow this format if you want a smooth easy process. 
    Overall It was a long, annoying, tedious process of ping-pong. Fortunately I did not have to do any translations.

    I briefly touched upon registration in Qatar, but that was back in 2015, and from what I remember is was simple documentation. Not sure what the requirements are present day. 
     
    Good Luck.... I'm sure you will be fine..... I learned the hard way as I muddled through the process with the SFDA.... 

    Michele K.


    Original Message


  • 3.  RE: Registration & Listing of Medical Devices in Saudi Arabia, Iran, Kuwait, UAE, Oman, Jordan, Qatar, Morocco, etc.

    Posted 22-Nov-2023 07:00

    Good Morning....

    I'm curious to know if Morocco is a single registrant country.  Can you have more than one AR in Morocco?  If not, can that AR authorize additional importers/distributors?

    Many thanks,



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    D Michelle Williams
    VP - Operations
    United States
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    Original Message


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