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The law governs the soil on which they can sell over the counter medical devices, not the nationality or Apple ID of who can buy it.
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That's not a screenshot of the ECG app. That's the Health app.

The text says your information will be collected in one place on your iPhone's Health app, which is what the photo shows.
But apple's policy is centered around where the users of the devices are based, not around where they are physically located at a certain moment. So their statement "in the US only" is poorly worded, unclear and incorrect. It should be "For US customers only", as customers with a US apple id and US purchased devices usually are able to use all the new features even if they are traveling or even living outside the US (like me, for example, I have US purchased devices and a US Apple ID account and have Apple Pay and news on all, and will soon have ECG on my US bought series 4 watch even though I live in mexico).
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It isn’t that they “didn’t bother.” They haven’t completed it yet. They aren’t familiar with medical device regulation in all the countries where they sell the Apple Watch.
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It is coming to more countries next year. Apple was upfront in its presentation in September that the US would get it first, just like many other features have started here and spread around the world gradually.
Surpisingly, one feature does exist that did not start in the US and is still unavailable there: carrier billing on iTunes and the App Store. That feature is available in about as many countries as Apple Pay, but the US wasn't the first one and it still isn't one of them.
 
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But apple's policy is centered around where the users of the devices are based, not around where they are physically located at a certain moment.

It's based on the law, which is where the product is sold.

The FDA only gave Apple clearance to sell it in the US. The FDA did not give Apple clearance to sell it to US Citizens in the UK, for example.
 
It's based on the law, which is where the product is sold.

The FDA only gave Apple clearance to sell it in the US. The FDA did not give Apple clearance to sell it to US Citizens in the UK, for example.

Obviously. But that doesn’t necessarily mean people can’t use ECG outside the US, it just means they can’t buy the apple watch with the feature enabled outside the US. Everyone who buys a series 4 in the US (not just US citizens) will have the ECG app enabled and can still use it anywhere in the world where they go. It’s not like the feature will be automatically turned off as soon as they cross the border out of the US. That’s why apple’s wording is poor. It is misleading.

As an example of how it’s misleading, because apple said “in the US only” when they announced apple pay, people tended to think that they couldn’t use apple pay at all in other countries. It was not true and they could and still can indeed use apple pay outside the US and the other supported countries, as many of us have proven. Once set up with a supported card, apple pay works everywhere contactless payment is accepted. Whether Apple pay is officially supported in the country where the merchant is located or not, it works.
 
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But apple's policy is centered around where the users of the devices are based, not around where they are physically located at a certain moment. So their statement "in the US only" is poorly worded, unclear and incorrect. It should be "For US customers only", as customers with a US apple id and US purchased devices usually are able to use all the new features even if they are traveling or even living outside the US (like me, for example, I have US purchased devices and a US Apple ID account and have Apple Pay and news on all, and will soon have ECG on my US bought series 4 watch even though I live in mexico).
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Surpisingly, one feature does exist that did not start in the US and is still unavailable there: carrier billing on iTunes and the App Store. That feature is available in about as many countries as Apple Pay, but the US wasn't the first one and it still isn't one of them.
But people (everyone, not just US citizens) can still use ECG in the UK or anywhere if they bought their watch in the US. It’s not like the feature will turn of as soon as they cross the border out of the US. Apple can’t sell the watch with ECG enabled outside the US. People can indeed use ECG outside the US once they bought the watch there. Do you see the difference?
They were cleared to sell a “medical device” in the US. They haven’t been cleared to sell them elsewhere yet. What people do with those “medical devices” is up to them. Apple isn’t required to track a user’s location and enable or disable that feature.
 
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But people (everyone, not just US citizens) can still use ECG in the UK or anywhere if they bought their watch in the US. It’s not like the feature will turn of as soon as they cross the border out of the US. Apple can’t sell the watch with ECG enabled outside the US. People can indeed use ECG outside the US once they bought the watch there. Do you see the difference?
Earlier you posted that Apple "overdid the restriction."

The restriction is they can only sell it in the US. How did they overdo that? Someone can buy it in the US and travel without it turning off, correct?

You also stated Apple was "trying to cover the sun with one finger."

The FDA doesn't cover selling it outside of the US. Apple will need to seek clearance for that separately. It's going to be a complicated process, requiring more than one finger, which is why they never gave a timeframe (unlike for the US).
 
I re-watched the video. Apple said “both of these features will be available to US customers later this year, and we’re working really hard to bring them to customers around the world.”

They didn’t give a timetable for customers outside the US, probably because they can’t predict it accurately.
 
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Earlier you posted that Apple "overdid the restriction."

The restriction is they can only sell it in the US. How did they overdo that? Someone can buy it in the US and travel without it turning off, correct?

You also stated Apple was "trying to cover the sun with one finger."

The FDA doesn't cover selling it outside of the US. Apple will need to seek clearance for that separately. It's going to be a complicated process, requiring more than one finger, which is why they never gave a timeframe (unlike for the US).
I already explained in a previous post how they overdid it: by going to the extent of disabling the app using the serial or maybe model number (i.e., restrict by where the device was purchased). Disabling the app using the region settings, as they did with others before ECG, was enough to comply with the legal restrictions of only selling a medical device in the US. Apple did more than that, so they overdid it.
 
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I already explained in a previous post how they overdid it: by going to the extent of disabling the app using the serial or maybe model number (i.e., restrict by where the device was purchased). Disabling the app using the region settings, as they did with others before ECG, was enough to comply with the legal restrictions of only selling a medical device in the US. Apple did more than that, so they overdid it.
The way Apple did it complies with the clearance they were granted for selling it only in the US.

Your suggestion would allow it to be sold (and activated) in countries that have not cleared it for sale.

The laws governing over the counter medical devices are stricter than content licensing deals that users may have changed region to circumvent in the past.

This is an entirely different situation.
 
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So next time, I will simply order an Apple Watch online from a US-shop and avoid all these problems. However, it will make the watch about 20% more expensive for me due to import taxes.
 
I would think that Apple would have an agreement about how the devices were to be restricted with the countries in question. I doubt that they left it to chance.

So next time, I will simply order an Apple Watch online from a US-shop and avoid all these problems. However, it will make the watch about 20% more expensive for me due to import taxes.

The taxman is harder to get around than Apple lol.

"Taxman" - The Beatles, George Harrison (RIP) wrote the lyrics I believe

1,2,3,4

Hrmm!

1,2...

1,2,3,4.

Let me tell you how it will be
There's one for you, nineteen for me
Cos I'm the taxman, yeah, I'm the taxman

Should five per cent appear too small
Be thankful I don't take it all
Cos I'm the taxman, yeah I'm the taxman

If you drive a car, I'll tax the street
If you try to sit, I'll tax your seat
If you get too cold I'll tax the heat
If you take a walk, I'll tax your feet

Taxman!
Cos I'm the taxman, yeah I'm the taxman

Don't ask me what I want it for (Aahh Mr. Wilson)
If you don't want to pay some more (Aahh Mr. Heath)
Cos I'm the taxman, yeah, I'm the taxman

Now my advice for those who die
Declare the pennies on your eyes
Cos I'm the taxman, yeah, I'm the taxman

And you're working for no one but me
Taxman!
 
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WOW! **** you Apple!

I love how the ****heads waited with releasing this information so people who bought on release day cannot return the watch.

I bet you'll need to buy a new shiny ECG enabled model if you want the feature after it's approved by your country too.
having tro assume this is some kind of joke.....or maybe you just didntwant to read the very clear comments that is was ONLY available in the US on lanuch sometime this year
 
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WOW! **** you Apple!

I love how the ****heads waited with releasing this information so people who bought on release day cannot return the watch.

I bet you'll need to buy a new shiny ECG enabled model if you want the feature after it's approved by your country too.

Well Apple did say it would be for US based customers only. None of us thought they’d be so extremely harsh on implementing and enforcing the restriction, but they did announce it. I’m glad for one thing I ordered my watch from the US. Will be getting it in a few days. Also, I doubt people in other countries will need to buy another watch to have ECG when apple gets clearance; all series 4 units do have the required hardware and apple just hides the ECG app after checking the serial or model number if it’s not a unit sold in the US, so they’ll definitely be able to remotely enable ECG in each country where they get clearance.
 
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If you’re outside the US, why not buy one from B&H or Adorama? I am assuming that they will ship internationally.

You could get lucky and customs won't find out.

Or they will, in which case they'll impose importing fees, and on top of that might still refuse the import altogether (at your cost, because you've just wasted your state's time) because it's a medical device without local approval.
 
You could get lucky and customs won't find out.

Or they will, in which case they'll impose importing fees, and on top of that might still refuse the import altogether (at your cost, because you've just wasted your state's time) because it's a medical device without local approval.

Well the importing fees may apply anyways. I doubt, however, that they would refuse the import altogether. That’s highly unlikely they’d be worried about a single device for a single user. They might refuse if it were a batch, but not just one.
 
You could get lucky and customs won't find out.

Or they will, in which case they'll impose importing fees, and on top of that might still refuse the import altogether (at your cost, because you've just wasted your state's time) because it's a medical device without local approval.

I doubt that customs cares or even knows - other than to collect fees on an Apple Watch. And, until the watch is paired with a phone the ECG app won’t work. Not that it would make much difference if an argument did happen lol.
 
It seems as if Apple hasn‘t even tried to get it approved in Canada.
Not surprising. If Apple’s history of previous feature rollouts is any good of a reference, we probably won’t see the ECG app becoming available to users anywhere outside the US during the first year after launch. Then, in the second year, ECG rollout will most probably start with other english speaking countries such as the UK and Australia. And then, until the third year, ECG will probably begin rolling out to other non-english speaking countries, most likely starting with Canada (which Apple seems to count as non-english because of the french they also speak) and China (a huge market and the only other than the US that apple seems to be most interested in), followed by some western EU countries such as Spain, Germany, France, Switzerland, Ireland, Italy, etc. And then, not until the fourth year, we’ll start seeing ECG in other countries such as Brazil, Russia or some of the other former Soviet Union countries.

So don’t worry if they haven’t bothered to apply for clearance in Canada, it’s because they likely don’t plan to roll out ECG there before 2021.
 
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Honestly they probably waited for the US FDA before they submit elsewhere.
As if someone knocked them back before they got the US approval it would look bad.

As we all know a Watch5 coming September 2019 they are not going to say well the ECG not available until July next year as people will hold out upgrading.
I be one of those now holding out now. or go watch3 which is a lot cheaper now.
 
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Honestly they probably waited for the US FDA before they submit elsewhere.
As if someone knocked them back before they got the US approval it would look bad.

As we all know a Watch5 coming September 2019 they are not going to say well the ECG not available until July next year as people will hold out upgrading.
I be one of those now holding out now. or go watch3 which is a lot cheaper now.

I am just giving an opinion based on Apple's past history. What I described as the likely rollout process for ECG is exactly how they rolled out Apple Pay before. It was US exclusive for a full year beginning in October 2014 when the service was turned on in the US for iPhone 6 users, and only started rolling out elsewhere a year later around the time when the next iPhone (6s) was launched. Many people must have held out of upgrading to the iPhone 6 during that first year and Apple did not care. Why would it be different now with ECG? the Apple Watch series 4 is selling like hot cakes anyways, and it seems apple isn't even bothering yet to ask for approval anywhere outside the US. Currently, they have delivery times close to Christmas on online orders for most models (though in stores they are still in stock).
 
I am just giving an opinion based on Apple's past history. What I described as the likely rollout process for ECG is exactly how they rolled out Apple Pay before.
Apple Pay is not an over the counter medical device.

I’m not sure how it works in your country, but in most places there are different regulations that govern banking and healthcare.
 
This is bullshizzle, IMO. The ECG reader is no different in my eye as the built in heart rate monitor.

How this has to classify as a medical device is beyond me. It doesn't do anything to affect your body directly, like being hooked up a pacemaker or insulin pump.

This is for end users, not for doctors.

Government regulators outrank you.
 
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