How is Digital Health Regulated in Canada?

How is Digital Health Regulated in Canada?

March 28, 2022 By

As innovation continues to evolve in digital health technologies, Health Canada is undertaking an adaptive initiative to support better access to those therapeutic products, especially in relation to medical devices. Health Canada established a new Digital Health Review Division within the Medical Device Bureau to facilitate pre-market review of digital health technologies and to adapt to the everchanging technologies in digital health. The utilization of digital health technologies in the current health care system allows for a more accessible, convenient, and cost-effective delivery of health care as well as more timely diagnoses and treatments for patients at home, at health care facilities, and in rural and remote areas.

Digital health technologies can utilize platforms such as computers and smartphones to incorporate stand-alone software applications, integrated hardware, and software systems. Health Canada, as the federal regulator, is supporting the application of digital health technologies to ensure the growing demands are met and only safe and effective products are being approved for the people of Canada.
The new Digital Health Review Division consists of experts in the area of digital health technology integrated medical devices and is continuing to develop a targeted review process to better align with other regulatory agencies and stakeholders.

Health Canada is dedicated to focusing on the following key areas:

  • Wireless Medical Devices
  • Mobile Medical Apps
  • Telemedicine
  • Software as a Medical Device (SaMD)
  • Artificial Intelligence
  • Cybersecurity
  • Medical Device Interoperability

Should you require additional information on your digital health products, contact us today for details.