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.
------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------
Original Message:
Sent: 13-Aug-2021 12:41
From: Anonymous Member
Subject: User Interface translation requirement for Canada
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