To ensure compliance with Canadian drug and device regulatory laws, software manufacturers will want to determine whether their health-related software products are classified as medical devices (or simply as non-regulated software) in Canada. That distinction has proven to be somewhat grey in 2015 as Health Canada continues to develop its position on software regulated as medical devices.
Software is considered to be a medical device by Health Canada if it: (1) provides the only means and opportunity to capture or acquire data from a medical device for aiding directly in diagnosis or treatment of a patient; or (2) replaces a diagnostic or treatment decision made by a physician. Health Canada has published guidance to help distinguish between Class I and Class II software medical devices.1 Some examples of health-related software that Health Canada does not typically consider to be medical devices are patient management software, the Wii Fit, pedometer software and Body Mass Index calculators.
Key Takeaways: If a health-related software product does not neatly fit within one of the above-noted categories, the intended use of the product (including statements made on the labeling, packaging and marketing materials) and the software's operational use of patient data, if any, may help to resolve how the product will be classified. At this stage, manufacturers will want to continue to monitor Health Canada's position on software and medical devices through publications, guidance documents and policies. At a time when mobile devices and an abundance of health-related applications are becoming increasingly commonplace, we expect to see more from Health Canada on this topic in the coming months and years.