This message was posted by a user wishing to remain anonymous
Bill 96 seems to apply to employers more than to manufacturers, but if a hospital needs to supply French-language materials for its employees I guess they'll have to buy products with French-language labeling.
Service manuals, too, for devices serviced by customers.
Original Message:
Sent: 30-Apr-2024 17:18
From: Leslie Hallock
Subject: Bill 96 and Quebec's language law
I have a follow up question beyond Class 1 devices. Does Bill 96 require French language even if CMDR does not? Devices not sold to the general public in Canada may be labelled in either English or French, and the IFU must be available in French if requested by purchaser. Under many scenarios, English language only is acceptable per CMDR. Does Bill 96 still apply in those cases and mandate French language labeling? Can someone direct me to section of Bill 96 where scope is defined to include all medical devices and other health products? I haven't yet found that clarification. Thank you.
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Leslie Hallock
Cerus
Walnut Creek CA
United States
Original Message:
Sent: 26-Apr-2024 14:37
From: Anonymous Member
Subject: Bill 96 and Quebec's language law
This message was posted by a user wishing to remain anonymous
Short answer - labels and instructions for use.
See medical device labeling guidance:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-labelling-medical-devices-including-vitro-diagnostic-devices-appendices.html
Original Message:
Sent: 26-Apr-2024 05:49
From: Lucy Robertshaw
Subject: Bill 96 and Quebec's language law
Hi,
We have been made aware of the Bill 96 and Quebec's language law, we sell class 1 medical devices in North America and we are just wondering if anyone can give me some advice on what documents need to be in French?
Many thanks
Lucy
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Lucy Robertshaw
CEO
Holo
Sweden
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