Consultation now open on draft guidance on Software as Medical Device regulation
Health Canada has published a draft guidance (Guidance) on the regulation of Software as a Medical Device (SaMD).1 The Guidance will apply to any software sold within the meaning of Food and Drugs Act, which Health Canada indicates would typically require transfer of ownership from one party to another and would include downloading software from an online store to a mobile device.
What you need to know
- Health Canada will consider software to be a medical device when: (a) it is intended to be used for a medical purpose and (b) it performs its purposes without being part of a hardware medical device (i.e., the software is not necessary for a hardware medical device to achieve its intended medical purpose).
- A software developer producing a SaMD under its own name or trademark is considered to be a manufacturer under the Regulations, and would be responsible for regulatory compliance.
- Stakeholders have been invited to provide comments to Health Canada on the Guidance by March 29.
Summary
The Guidance is intended to provide needed clarity to industry on when a medical device license is necessary for SaMD. The risk classification of the SaMD, which determines the category of medical device licenses needed for marketing approval, is established by considering the significance of information provided by the SaMD (in the context of a healthcare decision) and the state of the healthcare situation (critical, serious or non-serious).
The Guidance includes the following key points.
Inclusion criteria
Software will be considered SaMD if:
- it is intended to be used for a medical purpose(s); and
- it performs these purposes without being part of a hardware medical device.
Note that Health Canada interprets “medical purposes” as acquiring, processing or analyzing medical images or information from in-vitro diagnostic (IVD) medical devices, and supporting or providing recommendations about the prevention, diagnosis, treatment or mitigation of a disease to health care professionals, patients or caregivers.
Exclusion criteria
Software will not be considered SaMD if it is:
- not intended to acquire, process or analyse a medical image or information from an IVD device;
- intended to display, analyse or print medical information (e.g., software that provided relevant reference information based on the patient’s symptoms or care plan);
- only intended to support a health care professional, patient or caregiver in prevention, diagnosis or treatment decisions; and
- not intended to replace clinical judgment.
Note that Health Canada interprets “support” as the provision of information that does not trigger an immediate action.
Continuing exclusions
Health Canada will continue to exclude the following types of software from regulation as a medical device:
- software intended for administrative support of a healthcare facility,
- software to enable clinical communication and workflow,
- software for maintaining or encouraging a healthy lifestyle (e.g., an app that tracks calorie intake); and
- software serving as electronic patient records.
Classification
Each SaMD will be independently classified, even if it interfaces with other devices or is used as part of a large system.
- Non-IVD SaMD will be classified as Class I, II or III devices based on their intended use. The classification will depend on the severity of the healthcare situation in which the SaMD is used and the significance of the information provided by the SaMD. For example, SaMD used in critical healthcare situations and provides treatment or diagnosis information are regulated as a Class III device under the proposed framework.
- IVD SaMD will be classified according to the classification rules applied to conventional IVD devices.
- Health Canada has also published a list of example classifications for comment.2
Comments may be submitted by email to [email protected] or by mail to the Medical Devices Bureau by the March 29 deadline.
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