Canadian regulatory framework for software-based medical devices and emerging technologies
£40.00
From SaMD to AI, Canada’s regulatory approach is evolving – understand what it means for your software-driven medical technologies
English
In Canada, along with the rest of the world, the use of digital health technologies, including software-based medical devices, has risen dramatically. According to Health Canada, digital health technologies and software-based medical devices can improve access to healthcare information, facilitate more timely diagnoses and treatments, and improve access to care for patients at home, at healthcare facilities, as well as in rural and remote communities. Therefore, it is important to foster the development of such technologies for the benefit of the Canadian population, such as providing adequate support and directions for medical device manufacturers to market their digital health technologies and software-based medical devices in Canada. This article by Karen Zhou and Ginny Gattinger provides an overview of the latest guidelines provided by Health Canada to help assist device manufacturers in the development of their software-based medical devices.
Specification: 9 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2024 issue of the Journal of Medical Device Regulation.
