Government filings suggest Apple ready to launch Apple Watch ECG feature in Brazil and Jap...

Posted:
in Apple Watch edited June 2020
As Apple continues to build out global support for ECG capabilities offered on Apple Watch Series 4 and Series 5 devices, recent government filings show Brazil and Japan could be next on the launch list.

Apple Watch ECG


In June, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated its list of registered foreign manufacturers to add Apple as a certified entity, Mac Otakara reports. Companies on the list are evaluated based on contingencies stipulated in a legal act concerning the quality, effectiveness and safety of pharmaceuticals and medical devices.

While the nature of Apple's certification is not detailed in the PMDA publication, it is thought to be related to Apple Watch's ECG feature. In many countries, Apple must win approval from government health entities before marketing the ECG capability, and in some cases heart rate monitoring software, to consumers.

Prior to the Japan development, Brazil's Health Regulatory Agency, known by the acronym ANVISA, in May announced passage of a new resolution approving Apple Watch's irregular heart rate notification and ECG features for use by consumers.

Resolution No. 1.635 notes Apple's heart monitoring software was evaluated solely for its ability to detect atrial fibrillation, adding the accompanying ECG feature should be used only as an informational asset. As noted by both ANVISA and Apple, the hardware and software tool is not designed to detect heart attacks and does not diagnose heart disease.

Similar consumer warnings and device limitations came part and parcel with U.S. FDA clearance when Apple Watch launched in 2018.

9to5Mac reported on the Brazil's grant earlier today.

Health agency authorizations typically serve as a final step toward regional Apple Watch ECG availability, though they rarely offer insight into launch timing. After obtaining clearance from the appropriate body or bodies, Apple is able to activate the feature in a watchOS software update at its leisure.

Most recently, Saudi Arabia gained access to ECG data and irregular heart rhythm notifications with watchOS 6.2.5 in May.

Comments

  • Reply 1 of 7
    laytechlaytech Posts: 335member
    As ever Australia years behind other countries, sadly. Still not available here. Australian’s as a population are early adopters of technology but archaic government delays progress.
    JosephAU
  • Reply 2 of 7
    JosephAUJosephAU Posts: 43member
    Every time there is an update I hope Australia is getting it but nooooooooooooo....so disappointed 
  • Reply 3 of 7
    a09899a09899 Posts: 1member
    Yet, Apple did get approval here in Australia for several medical devices with our TGA-alas none are related to the Apple Watch still.

    Instead the 6 approved by the TGA are to to do with equipment used in relation to COVID-19:
    http://tga-search.clients.funnelback.com/s/search.html?from-advanced=true&collection=tga-artg&fmo=on&daat=0&query_or=&meta_i=&meta_F=&meta_A=&meta_H=Apple+Pty+Ltd+&meta_bts=%21Y&meta_I=&meta_B=&meta_D=&meta_d1day=&meta_d1month=&meta_d1year=&meta_d2day=&meta_d2month=&meta_d2year=
  • Reply 4 of 7
    boxcatcherboxcatcher Posts: 267member
    It boggles my mind that this has been available for a year+ in other countries (with all the data generated to validate operation during that time), yet it’s still getting approval in other countries? Good lord.
  • Reply 5 of 7
    laytech said:
    As ever Australia years behind other countries, sadly. Still not available here. Australian’s as a population are early adopters of technology but archaic government delays progress.
    I read a while back, Apple has not made any fillings for ECG to be listed on the ARTG, so as far as i am concerned, this has nothing to do with government delays.

    the news report sources are from "Government Fillings" which Apple has to apply for this feature, they have not applied yet. I will still continue by yearly upgrade of the Apple Watch, so features like this doesn't really matter to me since I will still be upgrading.

    Personally i have been waiting as well. the longest feature wait was for Apple Pay, that was very long.
  • Reply 6 of 7
    fred1fred1 Posts: 1,116member
    I’m confused (nothing new here): I was told by an Apple tech rep that if I bought the watch in a country where the ECG feature works and brought it to a country where it doesn't, that it would not work because of geofencing. But I was in Latvia a couples of years ago, where the ECG feature hasn’t been activated, and it worked. What’s the real story about this?
  • Reply 7 of 7
    svanstromsvanstrom Posts: 702member
    laytech said:
    As ever Australia years behind other countries, sadly. Still not available here. Australian’s as a population are early adopters of technology but archaic government delays progress.
    I read a while back, Apple has not made any fillings for ECG to be listed on the ARTG, so as far as i am concerned, this has nothing to do with government delays.

    the news report sources are from "Government Fillings" which Apple has to apply for this feature, they have not applied yet. I will still continue by yearly upgrade of the Apple Watch, so features like this doesn't really matter to me since I will still be upgrading.

    Personally i have been waiting as well. the longest feature wait was for Apple Pay, that was very long.
    Apple Pay was really fought by the Aussie banks, though. They reeeeeaaaaally didn't want any potential competitors taking away their control of the people.
    Rayz2016
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