L
LChristos
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.
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.