Medical Devices: Going Mobile?

Medical devices have officially crossed the border into a new territory that is both familiar and new to millions of consumers around the globe. The idea of smart phone apps with a medical purpose has been growing. There exist apps that monitor the activity of other medical devices, apps that can control insulin levels for diabetes patients, and many other apps that are medical in nature. These apps, called mobile medical apps, require medical device registration just like any other physical medical device in Canada and the US. This means that 510(k)’s in the US, and Medical Device Licenses in Canada are mandatory if you plan on releasing mobile software with a medical application. Some applications are exempt from requiring a 510(k), such as the apps that only provide reference information. Luckily there already exist a significant number of mobile medical app predicates to make the 510(k) process smoother. In Canada, a mobile medical app is regulated as a medical device so long as the function of the app fits Health Canada’s definition of a medical device. An application which acts as an accessory to a medical device is also regulated as a medical device in Canada. The evolution of the technological and digital age is quite intriguing, and it is only a matter of time before other highly innovative products enter our market.