Classifying Medical Device Software In Canada

Health Canada has indicated that it plans to release an updated notice on classifying patient management software in the coming weeks, modifying the notice it released on August 31, 2009.¹ The previous notice outlined the approach taken by the Medical Devices Bureau of Health Canada to classify patient management software as either a Class I or a Class II medical device.

Application of the Notice

The notice refers to "patient management software," suggestive of software that manages patient health records (e.g., eHealth records); however, the notice is intended to apply to medical software using patient personal health information and/or patient data for reporting, monitoring or analysis. Medical imaging software or patient diagnosis software that is sold as stand-alone software – that is, not always sold as part of a licensed medical device – would be subject to this notice.