When Does Software Stop Being Just Software?

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When is software regulated as a medical device?

Fitness software for phones, watches and other wearable devices is common.  So when does software cross a line and need to comply with medical device legislation? 

Medical devices used for health purposes are regulated and must meet certain standards or approvals depending on a risk profile.  In Canada medical devices are rated from class 1 through 4, class 4 requiring the most scrutiny.

Health Canada recently published draft guidelines on when software has a medical purpose that requires it to follow the medical device standards.

For example:

Software intended for maintaining or encouraging a healthy lifestyle, such as general wellness apps, are not considered to be for medical purposes.

Software is considered for medical purposes if it is intended for the purpose of supporting or providing recommendations to health care professionals, patients or non-healthcare professional caregivers about prevention, diagnosis, treatment, or mitigation of a disease or condition.

More examples of software that Health Canada considers is or is not for a medical purpose is in their draft examples document.

Health Canada is taking comments until March 29.

Anyone creating software that might possibly be for a medical purpose should take a look to see if they need to comply, or if they want to make comments.


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David Canton