Apple Watch: ECG In Australia

im pretty sure no-one is exclusively buying the Apple Watch because they think it is a medical device. It’s a bonus. If the ecg picked up any irregularities, that would be a red flag to investigate further. It has already saved lives in the US. Failing to approve it because it is not a medical device is farcical. The TGA are just protecting their patch. What a joke.

EleValenzuela wrote:

l have the apple watch 6. Somebody tell me if l cross to Mexico my ECG its not gonna work. Cause in mexico the app ECG dont have the permitions. Soo l can only use my ECG when l am in the US?

In what country did you buy the Apple Watch? What country is your Apple ID in?

Protecting their patch? You obviously don’t understand what the point of the TGA is. It isn’t about protecting industry, local brands and inventions etc. it’s about ensuring that claims made by companies in relation to health are accurate and true, and to stop products with dubious health claims coming onto the market. In addition to that it also ensures the quality of goods on the market.

Apple doesn’t get off scot free- their staff are telling Australian customers that these features are available here. The website has information that suggests the irregular heartbeat function works here. They call their staff “Specialists”, which suggests they specialise in Apple Products, and it denotes a sense of authority/ability to provide accurate information. People have purchased an Apple Watch largely to access these features. There are plenty of other choices out there that do similar things and cost a lot less - like older model Apple watches or fitness trackers, so if someone knew those features weren’t available, they may just make other choices.

miloks wrote:

Apple doesn’t get off scot free- their staff are telling Australian customers that these features are available here. The website has information that suggests the irregular heartbeat function works here. They call their staff “Specialists”, which suggests they specialise in Apple Products, and it denotes a sense of authority/ability to provide accurate information. People have purchased an Apple Watch largely to access these features. There are plenty of other choices out there that do similar things and cost a lot less - like older model Apple watches or fitness trackers, so if someone knew those features weren’t available, they may just make other choices.

Which staff? The in-store workers in Australia or the online help support? Their own australian website doesn't even advertise ECG https://www.apple.com/au/watch/

If you actually find some staff that mislead you in store, feel free to tell on them to the supervisor.

Note that Australian support goes here - https://support.apple.com/en-au/

But since many people search "Apple Support" in English on google even in Australia, you'll be leaded to US website. https://support.apple.com/

Australia also doesn't have their own support communities, they go automatically to the US-EN. Which is where you are right now. People may assume that you are from the United States but this is practically an international community for all English speakers.

[Edited by Moderator]

I’ve already said I’ve submitted feedback about the in store experience previously.

Back to the original point - the blame cannot be solely placed on the TGA/Australian Government. Apple have a lot to answer for as well. Please don’t comment on our government if you don’t understand ALL of the contributing factors here and understand what our TGA does.

It never takes long for the TGA trolls to comment. Welcome. No-one is buying the apple watch because they think it's a medical device. It is a bonus. The TGA is protecting no-one with this position - except themselves and their patch. In fact, I would argue it is actually preventing a bunch of people who may have heart conditions to investigate further. If your watch told you to get a check up, you would of course investigate with a halter monitor. And if your GP told you to investigate your heart, no-one is saying, no need to, my watch is all I need. It is a laughable position taken by the TGA.

You are incorrect in your assumptions that ...

~ no-one buys an Apple Watch because of the ECG function

~ the TGA is just protecting its patch

However, they are side issues - I believe the relevant issue is that Apple should be responsible enough to make a clear statement about what they are doing in Australia to live up to the COO’s 2018 statement on ECG that Apple are “working hard to bring to customers around the world."

That would end all the assumptions and speculation and be the sort of behaviour that is expected from a leading brand.

Luca,

Who should that be sent to at Apple?

Objective: get a clear, official , company statement on how approval for ECG is proceeding to give credibility to the COO’s statement that Apple are “working hard to bring to customers around the world." ?

I just want to have my trust restored in what Apple say.

Seems to me they are just burying their head in the sand about this commitment.

Y, I aou know

Or perhaps the TGA could have the vision to classify the apple watch as a watch and not a medical device (ECG machine). Lets be crystal clear on this, the watch is a watch is a watch. It has been approved in developed countries across the world including Switzerland, USA, UK, New Zealand, the list goes on. All of these countries have equal or superior regulatory bodies who have all chosen not to treat the apple watch as a medical device. There are many ways around this, including having apple customers acknowledge that the ECG function on the watch is not as reliable as a halter monitor. Simple. Again, its all about protecting the patch. Re your comment from the COO, I believe Apple are working hard to bring it to customers around the world. They know, however, that it will never reach the standard of a medical device in Australia.

You are incorrect.

The Australian regulatory requirements are not aligned with comparable overseas regulators. The watch ECG function has been approved in many major developed countries including USA, UK, Switzerland, Germany, NZ etc etc. Perhaps you could specify exactly which countries you are referring to?

Luca De Angelis wrote:

Official reply just received from the Medical Devices Information Unit - Authorisation Branch of TGA:

...

The Australian regulatory requirements are aligned with comparable international regulators so it is not anticipated that any technical definition would need to be amended to enable an overseas entity to meet the requirements of the regulations.

...

So they believe that Apple should try to pass their Apple watch and meet the requirements while Apple believes that its not possible to meet the requirements? Now I'm just seeing that TGA is offering no exceptions to Apple while Apple is struggling to find a way to get it across without loopholes or just straight given up knowing that it's not possible.

Yes but the last comment referred to Australia having comparable regulation to other countries and I was making the point that other major countries have approved the ECG function on the watch or are progressive enough to not classify a 'watch' as a 'medical device'.

lachlan211 wrote:

Yes but the last comment referred to Australia having comparable regulation to other countries and I was making the point that other major countries have approved the ECG function on the watch or are progressive enough to not classify a 'watch' as a 'medical device'.

Luca de stated that he posted the response to his email to the TGA: They weren't his words

Luca De Angelis wrote:

Official reply just received from the Medical Devices Information Unit - Authorisation Branch of TGA:

Saying his words were incorrect in a previous post.... may be a little inapplicable.

Samsung smart watch just approved to use ECG functions in Australia, I’m a long time Apple products supporter, just asking is there any chances for Apple smart watch to appeal on this case. Why Australia government only gave approval for Samsung, thanks.

I read the news from Tom’s guide, they said Samsung Galaxy 3 series have ECG functions, after read your reply, I just contacted Samsung Australia this morning, they said everything’s ready and will be launched early next year, have to wait and see, all my personal equipments are Apple products, don’t really want switch to Samsung, so hopefully Apple Watch can have same functions in the near future, cheers.