The Canadian Health Authorities have revised regulatory compliance requirements for Software as a Medical Device (SaMD) and related emerging technologies, and are currently seeking stakeholder input on the recently developed Software as a Medical Device (SaMD) draft guidance document until March 19th, 2019.
As software plays an important role in the healthcare sector, Health Canada fully realized the need to review the current Medical Device regulatory framework for Software as Medical Devices (SaMD) products in order to ensure regulatory requirements remain flexible enough to account for the rapid pace of technology and ensure safe and effective products are brought to market in a timely manner.
Based on International Medical Device Regulators Forum (IMDRF) guidelines, Health Canada has intended to better define how the existing Canadian Medical Devices Regulations can accommodate SaMD products in terms of definitions, inclusion and exclusion criteria, risk classification and other related issues.
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 Food and Drugs Act (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).
In the context of determining whether or not software is a Medical Device, Health Canada generally interprets medical purposes as follows:
- Intended to acquire, process, or analyze a medical image, or information from an In Vitro Diagnostic Device or a measurement/signal from a monitoring device or imaging device.
- 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.
Software that fits the above criteria can be broadly categorized under the terms Clinical Decision Support Software (CDS), that are intended for Health Care Providers (HCP), and Patient Decision Support Software (PDS), which are intended for patients and caregivers who are not HCPs. Examples of CDS and PDS that are SaMDs are provided on a draft document too.
The functionality of any software product then, dictates whether it qualifies as a Medical Device under Health Canada’s Regulations. 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 Food and Drugs Act, that software qualifies as a Medical Device.
Currently Health Canada will only be regulating software that is sold within the meaning of the Food and Drugs 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.
Medical Device manufacturers, healthcare professionals and interested public parties are encouraged to provide feedback and any questions on the overall clarity and content of the draft guidance document to the Therapeutic Products Directorate. Magellan platform is continuously aware of the most recent publications on Medical Devices and IVDs, please contact our team for more details on how Magellan could keep you abreast of all global regulatory initiatives.