Regulatory Open Forum

 View Only

  • 1.  Language requirements Israel

    Posted 29-Oct-2014 03:24
    Dear all,

    What are the language requirements for active medical devices in Israel? I could not find anything on the MOH homepage.
    The devices will be used in a professionel setting as well as in home use setting.
    If someone would have a reference this would be great.

    Thanks a lot for your help.

    -------------------------------------------
    Dirk Steinhoff PHD
    Regulatory Affairs Manager
    Hocoma AG
    Volketswil
    Switzerland
    -------------------------------------------


  • 2.  RE: Language requirements Israel

    Posted 31-Oct-2014 08:21
    We've recently obtained approval for some devices for professionals to use (not home use) in Israel.

    English only is OK.

    I recall from work related to consumer products that if Hebrew is included, it shall be no less prominent than any other included language.  I also recall at the time that for many Arabic countries, Hebrew was not allowed to be shown on the labeling.

    Hope that helps.

    -------------------------------------------
    Thomas Heckmann
    Regulatory Manager
    Reichert Inc
    Depew NY
    United States
    -------------------------------------------


    Original Message


  • 3.  RE: Language requirements Israel

    Posted 03-Nov-2014 01:28
    Dear Thomas,

    thanks a lot for this information.
    It helps a lot.

    Dirk

    -------------------------------------------
    Dirk Steinhoff PHD
    Regulatory Affairs Manager
    Volketswil
    Switzerland
    -------------------------------------------


    Original Message


  • 4.  RE:Language requirements Israel

    Posted 04-Nov-2014 04:07
    English is OK for professional use.
    For OTC / home use Hebrew and Arabic is obligatory. There are new regulations that came just recently in effect.
    and yes, Hebrew on product that goes into Muslim countries is not accepted by those recipient countries.

    -------------------------------------------
    Eytan Meisels
    Regional Director QA/RA LAmARCIS Alere
    Orgenics-Alere
    Rehovot
    Israel
    -------------------------------------------



    Original Message