On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD.
What Constitutes SaMD
Not all software falls within the scope of the Act and Regulations. The Guidance Document provides current interpretations of what constitutes a “device” or “medical device” in the Act and Regulations (including by reference to the definition of SaMD as developed by the International Medical Device Regulators Forum).
Whether software meets the definition of a “medical device” is largely driven by two issues: 1) the functionality of the software product; and 2) the manner in which it is represented or labeled for use.
The Guidance Document also provides more specific inclusion and exclusion criteria that Health Canada will consider in determining whether software is a “medical device”; however, these criteria are not rigid and other factors may also be considered.
A software is considered a “medical device” when: 1) it is intended to be used for one or more medical purposes; and 2) it performs these purposes without being part of a hardware medical device. Medical purposes are set out in the definition of “device” in the Act. Health Canada will generally consider software as having a medical purpose where it is intended to:
- acquire, process, or analyze a medical image, or a signal from an in vitro diagnostic device or a pattern/signal from a signal acquisition system or imaging device; or
- support or provide recommendations to health care professionals, patients or non-healthcare professional caregivers about prevention, diagnosis, treatment, or mitigation of a disease or condition.
Software that does not have a direct impact on the diagnosis, treatment, or management of an individual’s disease, disorder, abnormal physical state or symptoms are excluded. This includes:
- software intended for administrative support of a healthcare facility;
- software that enables clinical communication and workflow including patient registration, scheduling visits, voice calling, and video calling;
- software intended for maintaining or encouraging a healthy lifestyle, such as general wellness apps; and
- software intended to serve as electronic patient records or tools to allow a patient to access their personal health information.
The Guidance Document additionally states that various types of clinical decision support (CDS) and patient decision support (PDS) software may not meet the definition of “device”, and as such, are not subject to the Regulations. Specific examples of excluded CDS and PDS software and more detailed criteria are also provided.
If software is considered to be a “medical device”, it must be classified according to the Classification Rules in Schedule 1 of the Regulations. Classification of SaMD is based on a combination of factors, such as the intended use of the software, the conditions and diseases it is intended to treat, and whether the SaMD is intended for critical, serious or non-serious conditions. There are four classes of medical devices, with Class I being the lowest risk and Class IV being the highest risk. The Guidance Document provides a framework for classification and specific examples of software falling into the different classes.
The Guidance Document is an administrative document and does not have force of law, but provides information intended to assist SaMD applicants with compliance.
Health Canada’s Notice announcing the Guidance can be found here.