Apple Watch: ECG In Australia

Both the Kardia and the one you linked to are two axis ECG devices the Apple Watch is a single axis device. The sensor on the back of the watch does not count as as axis. Apparently your government wants multiple axis for approval.

The Australian Government is not dragging their feet. What evidence do you have to support this claim?

Apple has yet to even make an application (this information is in the public domain), and when questioned as to why they have given Australian media and consumers no answer.

Reportedly there is going to be an update of TGA regulations released in February 2021, if those will allow for approval of the ECG function on the Watch, Apple could then apply and go through the process.

Deggie, of course the technology would be different as apple uses proprietary technology in their devices. The statement you have made previously is that the issue can only be the Australian TGA, now that 2 other smart watch devices with the ability to take an ECG and also report irregularities with the Heart beat have been approved by the very agency that you said would have so much red tape and they would have specifications that would be impossible to meet, I point to this not being an issue solely with the Aust. TGA but apple’s well documented insistence that people comply with the Apple way of doing things else they not get the very feature people want, or the ability for their product to work with an Apple product.

Apple should be very embarrassed that with greater than 50% market share in Australia, and a feature that has been available in so many other countries for years, it has been beaten to the market for a very important feature, by Withings and the N95.

I think it is time for Apple to come clean with the exact reason they do not see providing the Australian market with such an important feature is not a priority for them. As many people above have mentioned, the Apple Watch is more expensive in the Australian market that just about any other market, for a device that promised features that are not available in this market is just not moral.

And now with alternate products being approved for the very same feature, demonstrates just how let down i personally feel by apple, and before you say it I have owned an Apple Watch since their release in Australia and upgraded every time a new series came out, same with my phones, iPad, and MacBook, so I would say I am very loyal to the organisation, I’m just very disappointed by their conduct.

I’d like to revisit my original post of some 2 months ago....

”Jan 17, 2019 bought Watch for ECG function/AFIB.

ECG not active in Australia, but at 2018 Special Event the Apple COO had said Apple "working hard to bring to customers around the world."

20 months later, it is reported https://www.gizmodo.com.au/2020/06/apple-watch-hearting-monitoring-australia-ecg/ that Apple has not even applied for approval and has declined to comment on why it is yet to put the devices on the register and on whether it has ever started this process.

I contacted Apple about ECG and got nowhere so would appreciate any suggestions on how to take this further as I feel I have been misled and ignored.”

Despite, not having the ECG function activated ( I knew it still had to be approved in Australia when I bought it) I am very happy with my Apple Watch, but very, very unhappy about Apple (it seems) not pursuing approval in Australia and ignoring requests for information of when an application for approval will be made.

Yes, some have opined here that Apple have not applied for Australian approval because it would not be approved - but there is no confirmation of this from Apple despite them being asked by journalists.

The bottom line:

• there is no evidence that Apple are pursuing their promise of getting approval for the ECG function in Australia
• they are ignoring requests for information on when (and if) they will apply for approval

Not good enough.

So , to me, it is not about whether the Apple Watch has better ECG capabilities than other watched but simply a matter stepping up to the line and telling us what is going on.

And, yes, I know they don’t respond to posts made here - but they would be aware of them.

They simply choose not to address what seems to be a failed promise.

No, I'm not missing the point:

1. Apple can't do this, as with the TGA, who have publicly stated this, any such dealings are at this point confidential and,
2. Apple doesn't work that way and they haven't since Mr. Jobs started the company. They have not done this is any of the 47 countries where they have approval. It is known when they do an update like the one they just did that included Russia and South Korea, who have also been waiting since 2018.

We cannot know if Apple has actually made an application with the therapeutic goods administration because that information might be considered confidential -- a gel might be listened but new tech has IP concerns. There is an example of an ECG watch in Australia but it's application is not publicly listed.

Unfortunately, the TGA cannot compel a company to apply; we might not be able to track confidential applications; and we have to rely on correctly update us.

D33D33C33 wrote:

It's irritating... I'd really like to know if Apple is actually proceeding along the path for obtaining TGA approval here.

TGA rules do not allow the Apple Watch ECG to be used in Australia.

This will be my last post on this because, to be frank, I don't get into discussions like this. I put it down to they have a reasonable market share here so they don't really care. There is a small amount of work, making sure they are registered as a manufacturer of medical devices, having done that also not a hard process, looking up the GMDN code if it isn't on the TGA dropdown list (have also done that) and providing a declaration of conformity..also not hard but as a company, it means that they have to take on the responsibility that the device meets the application. That is probably where Apple has an issue and that is not a high bar to meet and in fact is about the same as negligence laws in the US but given the addition of the ECG function wouldn't increase the market much in Aus then they have no reason to take that liability.

I'm sure that must be it and perhaps Apple likes the New Zealand market better than the Australian market. Perhaps you should write to Apple and volunteer to assist them? Of course you might want to read this entire thread and go to some of the links that have been provided where Australian journalists have said that Apple has had discussions with the TGA and due to the regulations not approving single access ECG that Apple has not applied because they know they will be rejected.

GregRLuck wrote:

Apple needs to initiate this. I actually bought my watch in the USA to get around this problem. That worked. But then that version does not work on Australian mobile networks. Unlike the phone which generally does.

Big PITA to send it to a friend in the US and take it back to the store.

All of this was an unsuccessful workaround for a problem Apple should fix. Yes it is work to apply to each of the medical device regulators in each country around the world. But they plan to do more with Health so they should make that application.

The problem with a universal cellular radio chip is that

A) it draws way too much power for the tiny battery in the Apple Watch.

B) it is much larger which would take away space from the already tiny battery.

C) roaming support would require the bigger more power hungry cellular chip

D) a more power hungry chip would generate too much heat for your arm, and would be very uncomfortable, if not damaging for your skin.

Using cellular radio chips that only focus on radio frequencies of a given region, and do not support roaming is a way to keep the Apple Watch from being too large, having a battery that only lasts a few hours, and generating too much heat.

The technology is improving each year, but also more features are being added each year.

And the cellular industry keeps changing the cellular protocols. The Apple Watch is still an LTE G4 tech, but the world is now moving to G5. But G5 is extremely power hungry, so it may be that about the time the G4 cellular radio gets sufficiently power efficient, the cellular industry will start de-commissioning the G4 network, and the Apple Watch will have to find a way to get a power efficient G5 chip into the Apple Watch, which may drive Apple into using even more different region specific radio chips.

There are real world limitations on what can be crammed into the Apple Watch.

These are all separate technical issues that having nothing to do with the TGA rules that do not allow Apple Watch ECG in Australia.

And it’s not much of a news given that for the past 6 months we’ve been reiterating in this thread that the government would have revised the legislation on this matter in February. Astonishing how many people still believe that Apple didn’t want to release these functionalities in Australia, even though we had proof the issue was with the legislation regulating this type of technology...

What really annoys me about this is that we have already had to wait over 2 years in Australia for Apple to give us the ecg feature. My wife and I both bought new watches at the time for that feature because it was advertised on the Apple Australian website. And now they make us wait several more weeks after they finally got around to submitting it to the TGA and getting approved. Come on Apple. Wake up!!!

Apple needs to apply to have goods registered for sale. It is a shame as many health funds extra policies cover part of the purchase if approved by TGA.

Write to the TGA here devices@tga.gov.au