According the Health Canada’s twitter account, Apple has yet to submit any kind of approval for the ECG on the Series 4 Apple Watch.

When asked whether or not it had received a medical device application for the Apple Watch Series 4 EKG functionality, Health Canada explained that it has not yet received any such application from Apple. Further, the government department noted that the decision to submit a “medical device license application” is up to the manufacturer

https://9to5mac.com/2018/12/11/apple-watch-ecg-canada/

This could prove worrisome for anyone anxious for the ECG in a country that is not the United States.  I had assumed that Apple hadn’t announced the ECG in other countries yet because other countries had taken long to get approval.  After all in the US the feature has cleared the FDA, but it is no approved.

The new Apple Watch features are cleared, but not approved, by the US Food and Drug Administration. It may seem a subtle point, but for something to be approved by the FDA, it is subjected to much more rigorous testing and data collection. Clearance is typically given to medical devices that have been determined to be substantially equivalent to another legally marketed device — an easier hurdle to cross.

https://www.cnn.com/2018/12/06/health/apple-watch-ecg-app-review/index.html

I’m intrigued to see what happens next.  Does anyone have any idea why Apple hasn’t started the process in Canada?  Maybe those of us that can use it are beta testers and don’t know it.

Have you found any heart conditions with your Apple Watch and the ECG app?  Are you waiting (frustratingly) for the app to come to your country? 

Let me know in the comments, hit me up on Twitter, or join the Facebook Group.