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Apple has included an ECG function in new Apple Watch models since 2018, providing users in select territories with the ability to measure the electrical activity of their heart. Apple now appears to be ready to extend the ECG feature to Brazil and Japan, based on recent government filings.

ecgapplewatchinaction.jpg

According to MacOtakara, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) recently updated its list of registered foreign manufacturers to include Apple as a "certified entity." Apple's inclusion in the list makes no mention of the ECG function, but it's more than likely that Apple's certification relates to the feature found in Apple Watch Series 4 and 5 models.

Apple was registered on March 25, 2020, which 9to5Mac notes was the same day the Brazilian government announced approval of Apple's ECG app. Apple will likely now issue an update to Apple Watch users in the two countries to enable the electrocardiogram feature and irregular heart notifications on their devices.

Apple routinely has to gain approval from government health agencies before marketing the Apple Watch's ECG feature in different countries. Apple won U.S. FDA clearance to promote the function when the Apple Watch Series 4 launched in 2018.

Saudi Arabia was the last country to gain ECG functionality and irregular heart rhythm notifications with the release of watchOS 6.2.5 in May.

Article Link: Apple Watch ECG Feature Likely Coming Soon to Japan and Brazil
 

tatsumi

macrumors member
Nov 12, 2015
75
95
Alright apple, I first thought maybe I won’t get the next Apple Watch here in japan (got series 3). But this might change my mind.
 

alpi123

macrumors 68020
Jun 18, 2014
2,023
3,377
id be surprised if it was Apples fault. We are a bigger market than some of the others that have ECG for Apple. No doubt due to some drawn out process by the relevant Australian health authorities
I really don't get why countries are being so damn slow regarding the approval of Apple's ECG. It's been almost two years since they introduced it and yet there are only so many countries who actually support that feature among other health related ones. If it took US to get that feature so quickly (I believe it was ready at launch?), then the rest of the world can do it too. Or maybe Apple prioritises which countries should get it before others?
 

amssullivan28

macrumors newbie
Apr 14, 2016
21
11
Gold Coast, Australia
Apple applied for and has received approval for several medical devices with our Therapeutics Goods Administration, all COVID-19 related-nothing to do with the Apple Watch but interesting nonetheless:

Apple were in discussions with the TGA regarding SaMD but nothing that was disclosed publically.
 
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AussieStu

macrumors regular
Feb 28, 2006
124
94
Conservative Australia always holds fun or good things back. From driving/camping on a beach, electric bikes to basic health features like ECG.
 
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Kamikazane

macrumors newbie
Jun 6, 2020
2
2
It’s confirmed. My Apple Watch series 4 bought in Japan had the ECG feature enabled. My os version is 6.2.5.
 
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MrMaxwell

macrumors member
Jul 17, 2016
92
304
DownUnder
Hmmm I bought the watch cause apple advertised ECG. I reckon I have a case for a refund as it never got implemented..

True. Even now on the AU product page it lists features of the watch including 'electronic and optical heart sensor' even though the electronic sensor cannot be used. I am sure they would refund anyone who pushed it...but then you don't have your watch.
 
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