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Classification of Medical vs Wellness Devices

Hello there,

Thank you for all of the guidance you folks have provided on the forums so far. It has been very informative.

I have been trying to get a handle on classification of digital health devices in Canada.

I have not been able to locate a formal guidance document on the difference between a wellness device vs. a digital health medical device beyond "intended use is a medical purpose" under the F&DA. The line between diagnostic vs monitoring health/wellness is much better demonstrated in UK/FDA/EU guidelines and I am wondering if I can rely on some of that guidance for classifications.

Also I have been searching for examples and guidance on the classification of Class I vs Class II medical device software. I located this notice from Health Canada: Notice - Software Regulated as a Class I or Class II Medical Device (File #: 10-125797-779 - sorry, I can't include links)
however I am unsure if it can still be relied upon for guidance.

Thank you for your time.
In my experience, the classification heavily leans upon the intended use and labelling of the device in question. I would also refer to the IMDRF SaMD guidance document and the US FDA MDDS guidance as Health Canada supports their classification decisions. If all else fails, the Device Licensing Services Division/Device Classification division can provide classification assistance with the provision of detailed labelling of the device in question for review.

RA Guy

Involved In Discussions
Hi LChristos

Be aware that Health Canada is only starting to develop formal guidance and policy on some of these issues. See the slides they presented in May (attached).

Health Canada appears to be aligned with the SAMD work done with the IMDRF.

I agree with liquidimpulse. You need a well defined intended use and follow up with a dialog with Health Canada for their input to your regulatory approach.


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