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  • 1.  User Interface translation requirement for Canada

    This message was posted by a user wishing to remain anonymous
    Posted 13-Aug-2021 13:45
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,

    We have a class II SaMD product as per Health Canada classification with user interface available only in English. The IFU and eIFU is available in both English as well as French. 

    For selling in Canada is it required to have the UI also available in French?

    Thanks


  • 2.  RE: User Interface translation requirement for Canada

    Posted 14-Aug-2021 04:23
    Good day,

    In most regulated countries, "labelling" includes the IFU, labels on the device, labels on the product, and any other information being provided to the user needs to be considered for translation - including user interface on software.  You could probably be proactive to ensure the UI is available in French or you can wait until Health Canada tells you otherwise seeing your product in the field.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: User Interface translation requirement for Canada

    Posted 14-Aug-2021 10:57
    Thanks Richard for your guidance. We are under the impression that for Canada English is acceptable provided all warnings and cautions are given in the translated version in IFU's.  In Quebec there is a specific requirement to have the user interface in French or we should be able to provide it when asked by the customer.


    Thanks.

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    Anuradha Iyer
    Regulatory Approbation Officer
    Indore
    India
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    Original Message


  • 4.  RE: User Interface translation requirement for Canada

    This message was posted by a user wishing to remain anonymous
    Posted 16-Aug-2021 11:31
    This message was posted by a user wishing to remain anonymous

    Hi Anuradha,

    I believe that the French translation needed for Quebec is different from the French translation needed for France as the language has evolved locally. You may want to check this before proceeding.

    Best regards.
    Original Message


  • 5.  RE: User Interface translation requirement for Canada

    Posted 16-Aug-2021 13:30
    Edited by Kevin Randall 16-Aug-2021 13:32
    Instructions for use (like on-screen prompts and instructions) and other labeling are generally understood to be crucial elements of the user interface and vice versa (e.g., see IEC 62366, AAMI HE 74 & 75, and the like).  Accordingly, the language requirements for such aspects of the user interface are primarily governed by applicable regulatory requirements for labeling.  In those terms, Section 23 of Health Canada's MDR allow the instructions for use to be in either French or English, except for when the medical device will be sold to the general public, in which case both English and French are required.  Aside from the pure regulatory perspective, also be sure that the particular needs/preferences of the targeted intended users are also sufficiently considered by way of corresponding design inputs, risk analysis, usability study(s), etc.

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    Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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