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  • 1.  UAE Authorized Representative

    Posted 24-Sep-2020 08:30

    I'm looking for an authorized representative for medical devices in UAE.  I've reached out to Freyr Solutions and Titans Medical for info about their services.  Does anyone have experience with either of these companies?   Thanks!

     

    Elizabeth Schultz

    Regulatory Manager

    Buffalo, New York

     

     



  • 2.  RE: UAE Authorized Representative

    Posted 25-Sep-2020 20:25
    Hi Elizabeth,

    I was in the same situation earlier this year and wanted to use a local AR, but have found for some of the Middle Eastern countries that those type of consultants don't exist. Because the cost of using a "super-consultant" (e.g. such as one of the companies you reference below) was so much more expensive than the actual registration fees, I ended up deviating from my normal policy and decided to work directly with the distributor on the registration.  

    It's actually worked quite well, as they provided me with access to their account on the MoH online portal, so I can create the applications myself.  They pay the fees and do all of the face-to-face activities.  The best thing is that my company is listed as the MAH in the licenses, so I still have full ownership. 

    Not sure of your specific situation, but it might be worth considering that pathway...

    Tina

    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
    ------------------------------

    Original Message


  • 3.  RE: UAE Authorized Representative

    Posted 28-Sep-2020 08:50

    Many thanks for the advice!

     

    Reichert, Inc.

    Elizabeth Schultz | Regulatory Manager

    Tel: 716-686-4568 | Fax: 716-686-4545 | elizabeth.schultz@ametek.com

    3362 Walden Avenue | Depew, New York 14043 USA | www.reichert.com

    AMETEK ULTRA PRECISION TECHNOLOGIES

     




    Original Message


  • 4.  RE: UAE Authorized Representative

    Posted 26-Sep-2020 10:51
    Dear Elizabeth,

    In UAE the AR can be your distributor only, unlike in KSA where the AR and distributor are separate.

    Better to have a contract with distributor as they have the right to import, distribute and register the product.

    for UAE AR is called local distributor.

    ------------------------------
    Shreya Jain
    Dubai
    United Arab Emirates
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    Original Message


  • 5.  RE: UAE Authorized Representative

    Posted 28-Sep-2020 08:01
    We have been distributing to the UAE and the KSA for many years.  Our sole-distributor in each country is also our AR in that country.  They can be the same entity in the KSA.  We have had no issues with this arrangement in either country.

    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
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    Original Message


  • 6.  RE: UAE Authorized Representative

    Posted 28-Sep-2020 08:46

    Thanks for the responses! 

     

    We have several dealers in UAE.  Will we have to authorize each of them to sell certain products or must we limit ourselves to a single dealer who will act as Authorized Representative?

     

    Elizabeth

     




    Original Message


  • 7.  RE: UAE Authorized Representative

    Posted 28-Sep-2020 08:50
    Dear Elizabeth,

    Yes you need to authorize each distributor for every product they sell or you have contract with.

    This Letter of authorization is required during registration and importation.

    You can a make a single letter for each distributor listing the products they are authorised for.

    ------------------------------
    Shreya Jain
    Regulatory Affairs Manager
    Dubai UAE
    ------------------------------

    Original Message


  • 8.  RE: UAE Authorized Representative

    Posted 28-Sep-2020 09:45

    Many thanks!

     




    Original Message


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