Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device

[milandy]

We are exploring entering the Canadian market with professional-use software -- a clinical reporting system -- which is not considered a "medical device" per Canadian regulation (or here in the US for that matter).

Our software is in English, along with all its labeling. The software creates reports in English which become part of the patient's medical record.

I have a couple of questions regarding our French language requirements:

• My understanding is that for professional-use, regulated medical devices, you must provide, at a minimum, French labeling which addresses any safety risks. Would this be true of unregulated medical software such as ours?
• As I mentioned, the reports our software produces are in English and become part of the patient record. Would our software be required to produce reports in French?
• If we are unable to meet these or any French-language requirements, would we be allowed to market the device in Canada, stating it is only available in English?

FWIW, I told my company there was no way we would be allowed to market software in Canada without addressing the French labeling issue, irrespective of where in Canada we intend to sell it. Further, I told my company that French-speaking doctors practice medicine in French and maintain patient records in French, and for this reason, we would be required to generate reports in French, again, irrespective of where in Canada we intend to sell our software.

Any help?

 

[shimonv]

Hi Milandy,
If your product is not a medical device then the Canadian Medical Device Regulation does not apply to it. You will need to do some research into which commercial law (if any) applies to a software only product. Either way, from a commercial prospective - if you don't support both languages, you are likely to loose some clients. Perhaps you can commercialise the English version while translating the GUI and User's manual. Hope this helps.

 

[RA Guy]

We are exploring entering the Canadian market with professional-use software -- a clinical reporting system -- which is not considered a "medical device" per Canadian regulation (or here in the US for that matter).

Our software is in English, along with all its labeling. The software creates reports in English which become part of the patient's medical record.

I have a couple of questions regarding our French language requirements:

• My understanding is that for professional-use, regulated medical devices, you must provide, at a minimum, French labeling which addresses any safety risks. Would this be true of unregulated medical software such as ours?
• As I mentioned, the reports our software produces are in English and become part of the patient record. Would our software be required to produce reports in French?
• If we are unable to meet these or any French-language requirements, would we be allowed to market the device in Canada, stating it is only available in English?

FWIW, I told my company there was no way we would be allowed to market software in Canada without addressing the French labeling issue, irrespective of where in Canada we intend to sell it. Further, I told my company that French-speaking doctors practice medicine in French and maintain patient records in French, and for this reason, we would be required to generate reports in French, again, irrespective of where in Canada we intend to sell our software.

Any help?

You need to familiarize yourself with the Quebec provincial law (C-11) with respect to language requirements in Quebec. Chapter 7 covers issues of commerce (copy link below)
legisquebec.gouv.qc.ca/en/ShowTdm/cs/C-11

I don't think that an English only professional use software would encounter any problems outside of Quebec even though there are some enclaves of French speaking/bilingual communities (e.g., New Brunswick, Eastern Ontario). New Brunswick is the only officially bilingual province, so there may be some research needed there.

From this brochure, it seems that hospitals need to offer patient services in both languages, but internal operations are at the discretion of the institution. (copy link below)
officiallanguages.nb.ca/sites/default/files/imce/pdfs/ola_brochure_english1.pdf

You did not elaborate on what your software does or why it woud not be considered a medical device in either the US or Canada, so I can't comment further on that aspect.

Hope this helps.