Health Canada: Approving a Potential Apple Watch ECG Application Can Take 15 Days
Earlier this week, Health Canada updated Canadians to say Apple is “still indicating” the ECG feature in Apple Watch Series 4 models are coming to Canada.
This morning, when asked how long it takes for an application to be approved by the federal agency, Health Canada responded to us and others on Twitter to say, “we can deliver a decision as quickly as 15 calendar days after a company applies.”
We can deliver a decision as quickly as 15 calendar days after a company applies. More on review of digital health technologies: https://t.co/tshLkdWGAi
— GovCanHealth (@GovCanHealth) April 25, 2019
This is the first time we’ve seen Health Canada reply in further detail regarding a potential application from Apple regarding heart features in Apple Watch.
Health Canada also pointed to a government website link, regarding Digital Health Technologies, dated April 10, 2018. The site details:
Given the fast pace of innovation in digital health technologies specifically in relation to medical devices, Health Canada is undertaking an initiative to adapt its approach to support better access to therapeutic products based on healthcare system needs. Under the “Regulatory Review of Drugs and Devices” initiative, Health Canada is establishing a new division within the Therapeutic Products Directorate’s Medical Devices Bureau to allow for a more targeted pre-market review of digital health technologies, to adapt to rapidly changing technologies in digital health, and to respond to fast innovation cycles.
As the federal regulator of medical devices, Health Canada 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, health care systems and industry, while ensuring that they remain safe and effective for the people of Canada.
With the ECG app in Apple Watch Series 4 already being approved by the U.S. Food and Drug Administration (FDA), plus in countries in Europe and Hong Kong, there’s no reason why Health Canada would deny Apple’s future application.
The ECG feature in Apple Watch Series 4 can report an ECG in just 30 seconds, by having a user touch the Digital Crown with their finger.
For now, it’s just a matter of time for Apple to submit its application for Apple Watch heart features. With a decision being made “as quickly as 15 calendar days”, that means Apple could apply at the last minute prior to an event or announcement, to keep the news under wraps.
What do you think? When will Apple Watch get the ECG app launch in Canada?