Software as a Medical Device (SaMD): Definition and Classification
The Medical Devices Regulations have been established under the authority of the Food and Drugs Act and apply to all medical devices imported or sold in Canada. The Regulations utilize a risk-based approach to regulating products within its scope.
On December 18, 2019 the finalization of the guidance document on Software as a Medical Device (SaMD): Definition and Classification came into effect. This guidance document clarifies how SaMD fits into Health Canada’s regulatory framework for medical devices, based on current interpretation of the definitions of “device” and “medical device” in the Act and Regulations. It provides detailed information to companies on what is regulated as SaMD, and what is not. Health Canada tried to harmonize the classification of SaMD with the regulations of other countries, where possible.
When the intended or represented use of software is for one or more of the medical purposes set out in the definition of a device as stated in the Act, that software qualifies as a medical device. The regulatory classification of SaMD is dependent on the manufacturer's labeled intended use for the product and the applicable Classification Rules in Schedule 1 of the Regulations.
Currently, Health Canada will only be regulating software that is sold within the meaning of the Act, which generally requires the transfer of ownership of a device from one party to another. For example, this would include the downloading of software from an online store to a mobile device and similar transactions.
Health Canada considers that software is a medical device when:
· It is intended to be used for one or more medical purposes as outlined in the definition of device in the Act, and
· It performs these purposes without being part of a hardware medical device (i.e., it is not necessary for a hardware medical device to achieve its intended medical purpose).
It has been Health Canada's longstanding position that the following types of software do not meet the definition of a medical device and are therefore not subject to the Regulations:
· Software intended for administrative support of a healthcare facility,
· Software that enables clinical communication and workflow including patient registration, scheduling visits, voice calling, 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.
In efforts to align regulatory processes for SaMD with other international jurisdictions, Health Canada has determined that various types of clinical decision support/patient decision support software may not meet the device definition - and therefore would not be subject to the Regulations - when it meets all of the four criteria
1. Software that is not intended to acquire, process, or analyze a medical image or a signal from an IVDD or a pattern/signal from a signal acquisition system
2. Software that is intended to display, analyze, or print medical information about a patient or other medical information (such as demographic information, drug labelling, clinical guidelines, studies, or recommendations).
3. Software that is only intended to support a health care professional, patient or non healthcare professional caregiver in making decisions about prevention, diagnosis, or treatment of a disease or condition.
4. Software that is not intended to replace the clinical judgement of a health care professional to make a clinical diagnosis or treatment decision regarding an individual patient.
In addition to the exclusion criteria, other factors may need to be considered when determining whether software would qualify as a medical device.
Due to the fast-changing technological environment, Health Canada will continue to adapt its policy approach to Software as a Medical Device (SaMD) as this field evolves.
· Guidance Document: Software as a Medical Device (SaMD): Definition and Classification
· Guidance Document: Software as a Medical Device (SaMD): Classification Examples