The Canadian regulations governing medical devices is administered by Health Canada, a department of the government of Canada. The regulations are stringent and the application process for a medical device is lengthy in duration. To sell the CaCiRa product as a medical device, it would need to gain approval by Health Canada as Electrocardiographs are classified as a Class II and Class III medical devices in Canada. Class II and Class III classification is warranted based on the application of the risks associated with the products, in medical application the failure of the device in monitoring a patient’s heart rate can lead to catastrophic outcomes such as death.

In the United States, medical device classifications are governed by the Food and Drug Administration, a federal agency of the government. Class III products are defined as a product that processes high risk and high potential therefore requires FDA approval for direct to consumer applications, whereas Class I and Class II products are low risk and simply requires clearance for application. In 2018, the US Food and Drug Administration cleared two features of the Apple Watch Series 4 under the Class II classification [ref]. The first feature concerns with an advanced electrocardiogram technology and the second feature concerns with an irregular health rate rhythm notification for the individual. This clearance is not meant to replace a doctor visit for the individual and not meant to be applied in individuals under the age of 22. The clearance as a medical grade application for the Apple Watch was granted on the basis that previous approval has been obtained by similar application of the technology. However, many other wearable technology providers sell directly to the end consumers through the exception created by the “General Wellness Policy for Low Risk Devices” as established by the US Food and Drug Administration. Under this policy, software and hardware providers that are created with the intention “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or disorder” are exempt from requiring classification as a medical device before approaching the market. Apple Watch began its initial sales using this exception before being approved as a medical device, other popular companies using this exception include Fitbit, etc.

in determining whether a device meets the guidance for a General Wellness Product, the following questions required to be answered: