Health Canada’s Approach to Digital Health Technologies
HealthCanada is establishing a new division within the Therapeutic Products Directorate’s Medical Devices Bureau to allow for a more targeted premarket review of digital health technologies, to adapt to rapidly changing digital health technologies, and to respond to fast innovation cycles.
Digital health technologies can include stand-alone software applications as well as integrated hardware and software systems which can utilize platforms, such as computers, smartphones, tablets, and wearables. These technologies can improve access to healthcare information, facilitate more timely diagnoses and treatments, and improve access to care for patients at home, at health care facilities, as well as in rural and remote communities.
As the federal regulator of medical devices, HealthCanada is supporting the market emergence of current and future medical devices using a digital health technology in order to meet the growing demand from patients, healthcare systems, and industry, while ensuring that they remain safe and effective for the people of Canada.
Key areas of focus for Health Canada under this initiative include:
Wireless Medical Devices.
Mobile Medical Apps.
Software as a Medical Device (SaMD).
Medical Device Interoperability.