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  • 1.  eIFUs in the Middle East

    Posted 25-Jan-2022 20:19
    Greetings!

    Is there any recent intelligence as to whether these countries accept electronic IFUs for professional use devices?  

    Egypt
    Iraq
    Lebanon
    Qatar
    United Arab Emirates
    Yemen

    I've Googled myself crazy, but can't find any info...

    Thanks in advance for any recent experience and/or references!

    Tina

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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  • 2.  RE: eIFUs in the Middle East

    Posted 26-Jan-2022 03:34
    Good day Tina,

    The only one I am aware of is Saudi Arabia.  I have not seen anything specific for the countries listed in the post.  With that said, many non-main regulated countries do not have regulations for specific compliance like eIFU, but they also may not prohibit this either.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: eIFUs in the Middle East

    Posted 26-Jan-2022 04:22
    Hello Tina, 
    I hope you are doing well & safe!
    This topic is not clearly mentioned within the regulation, however our common practice differentiate whether the device is for professional or patient use, 
    For UAE, Egypt 
    Professional use : will accept eIFU as long as it was included within the registration file , and English only accepted too , 
    Patient use: require physical IFU or at least Local AR needs to print and attach per each product locally, and Arabic is mandatory 
    UAE: Registration of a Medical Equipment | Services | Ministry of Health and Prevention - UAE (mohap.gov.ae)

    Iraq, Yemen : no individual product registration yet, only Manufacturer listing along with product mass listing , no product related documents.

    Lebanon, only Implantable MD listing is required using DOC, |FSC or CFG, the rest of MD is controlled vis import permit from MOH.
    Qatar: recently regulated Implantable MD , no specific requirement for IFU, 

    Best Regards 
    Rehab Soliman 
    MEA-Turkey Regulatory Affairs Manager
    Envista corporation

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    Rehab Soliman
    Brea CA
    United States
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    Original Message


  • 4.  RE: eIFUs in the Middle East

    Posted 26-Jan-2022 11:37
    Hello Tina

    Thank you for the question, the answers are valuable (thanks to Richard and Rehab as well).

    One way to approach the situation is to have paper IFU und eIFU in parallel to start with. Once you enter the market you can approach the regulatory body of the country and ask if the eIFU is sufficient (especially if it is provided in the local language in addition to English, something that is much less complex with eIFU). In fact, the countries on your list might be by far more advanced with the everyday use of mobile internet and might encourage the use of technology.

    Hope this adds value.




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    Hans Strobel
    www.dokspot.io
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    Original Message


  • 5.  RE: eIFUs in the Middle East

    Posted 26-Jan-2022 20:22
    Edited by Tina O'Brien 26-Jan-2022 20:23
    Thanks for the responses - very helpful :)

    Fingers crossed there will be more info available for these countries by the time we're ready to implement eIFUs. 

    Tina

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

    Original Message


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