Apple Watch ECG Feature Receives Final Medical Approval in Japan

[MacRumors]

Apple's ECG app and irregular heart rhythm notifications on the Apple Watch Series 4 and 5 have received domestic approval and certification from Japan's medical authorities, indicating that both features should go live in the country very soon.

The approval was confirmed by the Japanese Association for the Advancement of Medical Equipment (JAAME) on Friday, September 4, and subsequently reported by tech blog iPhone Mania today. An imminent update to Apple's watchOS will likely turn on the features for existing Apple Watch owners.

As a result of the approval, the Ochanomizu Department of Cardiology has begun moving forward with its Apple Watch Outpatient program, which will help registered patients use devices to help them record suspected arrhythmia attacks and submit them for further detailed examination.

‌Apple Watch‌ Series 4 and 5 users can generate an ECG waveform in just 30 seconds by placing their finger on the Digital Crown. The idea is that you can take this information to your doctor, if the results are abnormal, and use it as a basis to discover if you have any larger issues at hand.

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.

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated its list of registered foreign manufacturers to include Apple as a "certified entity" in June.

Article Link: Apple Watch ECG Feature Receives Final Medical Approval in Japan

 

[budfox]

?Australia anyone.

 

[TiggrToo]

?Australia anyone.

Why Apple Watch Series 5 Won't Get The Heart Testing Feature in Australia

The Apple Watch Series 5 was announced at Apple’s big iPhone launch in mid-September with new features including always on...

www.gizmodo.com.au

 

[Cleartz]

I got really exited until I finished reading the end of the title.

 

[Roniniku]

I live in Japan, have a series 5 I bought here and the ECG app has been live since at least around the new year. It might have just gained official approval but it's been turned on for months.

 

[incoherent_1]

I live in Japan, have a series 5 I bought here and the ECG app has been live since at least around the new year. It might have just gained official approval but it's been turned on for months.

Just curious: Is your Apple ID set/linked to another country?

 

[JoshBoy]

And Australia keeps waiting

 

[incoherent_1]

I understand why governments want autonomy over these kinds of things, but there has to be a better way to do it. Wouldn’t it make sense for some countries to grant reciprocity or at least accelerated approval tracks for products approved in certain countries with similar standards?

 

[Biglethal69]

Still waiting in AUSTRALIA!!!!! APPLE!!!!!!

 

[Tres]

I live in Japan, have a series 5 I bought here and the ECG app has been live since at least around the new year. It might have just gained official approval but it's been turned on for months.

Either you have a really specific bug, or you activated your Apple Watch while overseas, because I don't know anyone that can use ECG with an Apple Watch they activated in Japan.

 

[nitramluap]

Why Apple Watch Series 5 Won't Get The Heart Testing Feature in Australia

The Apple Watch Series 5 was announced at Apple’s big iPhone launch in mid-September with new features including always on...

www.gizmodo.com.au

Yes, except there is an exception in Australia in that any medical device that has CE approval automatically qualifies and doesn’t require special approval from the TGA. I think the TGA is just holding out on Apple so they can cash in, because product companies have to pay a large sum of money to have things approved.

It’s stupid really as it’s a useful feature and while it might help detect issues in some people, it will only result in the patient getting a proper 12-lead ECG to confirm any pathology. Nobody is suggesting they’re going to be using it as a clinical monitor during any clinical procedure.

TGA is being oddly obstructive with this. I’m hoping that they do have approval coming soon - in parallel with approval for the almost certain pulse oximetry in the Apple Watch Series 6. If we don‘t have that approved then that’s going to hurt Apple.

 

[Madonepro]

Yes, except there is an exception in Australia in that any medical device that has CE approval automatically qualifies and doesn’t require special approval from the TGA.Series 6. If we don‘t have that approved then that’s going to hurt Apple.

Are you sure? Bicycle Helmets introduced into Australia/NZ with CE approval have to get Australian approval as well, and often takes 18 months. Pro cycling races have to get exemptions when hosting international events.

 

[PickUrPoison]

And Australia keeps waiting

Apple had discussions with the TGA but that seems to be as far as it went. My guess is Apple doesn’t see a pathway to approval, and at this point I personally would assume the feature is not likely to come to market.

Apparently your requirements for medical devices are very strict. That’s not necessarily a bad thing at all, but with the US, Japan, EU, UK etc. all accepting the regulatory package Apple has assembled, it’s hard to say that it’s insufficient per se. But it doesn’t seem to be sufficient for the TGA.

Hopefully there is at least one approved ecg device available in your market for consumers who might wish to have one. But it doesn’t appear it will be the Apple Watch ?

EDIT: Based on a good find from @amssullivan28, it looks like Australia’s medical device regulations are being updated. Maybe February 2021?

Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019

This is the first package of regulatory changes for the broader medical device reforms

www.tga.gov.au

 

[DinkThifferent]

Still waiting in AUSTRALIA!!!!! APPLE!!!!!!

Still waiting in AUSTRALIA!!!!! APPLE!!!!!! AUSTRALIA!!!!!

fixed that for ya.

 

[SaSaSushi]

I live in Japan, have a series 5 I bought here and the ECG app has been live since at least around the new year. It might have just gained official approval but it's been turned on for months.

I bought my series 4 here in Japan two years ago and since the ECG app has only just been approved and the firmware update enabling it hasn't been released yet the only way this is true is if the Apple Watch you purchased here in Japan is an overseas model.

As for the news, finally! It's been a long wait.

 

[h3ysw5nkan]

I'm hoping for under-display TouchID or FaceID.

 

[Apple_Robert]

Glad to see this. Hopefully, the Apple Watch can help save lives in Japan like it has other parts of the world. It sure took a long time to get approved.

 

[SaSaSushi]

Either you have a really specific bug, or you activated your Apple Watch while overseas, because I don't know anyone that can use ECG with an Apple Watch they activated in Japan.

It wouldn't matter where a Japanese market model was activated. The ECG app will not work until the official firmware enabling it is released.

It is possible to buy overseas models here in Japan. I did for my previous Series 2. I purchased it while on a trip home in the USA. The downside of that was that I lost all ability to use Apple Pay locally here in Japan, no SUICA transit support, etc.

 

[Tres]

It wouldn't matter where a Japanese market model was activated. The ECG app will not work until the official firmware enabling it is released.

It is possible to buy overseas models here in Japan. I did for my previous Series 2. I purchased it while on a trip home in the USA. The downside of that was that I lost all ability to use Apple Pay locally here in Japan, no SUICA transit support, etc.

Hmm, you're right. Even if you pair a Japanese model in a country where ECG is enabled, it won't work it seems...

Apparently to use ECG you need:
1. A model purchased in a country where ECG is enabled
2. Perform initial pairing in a country where ECG is enabled

According to this recent guide anyway:

Apple WatchのECG（心電図）機能を日本でも使用できる方法（まとめ編） | トリニティ

最後の追記：とうとう、Appleから正式にリリース「Apple Watchに心電図アプリケーションと不規則な心

trinity.jp

(Not that it really matters since it'll be available to everyone soon anyway)

 

[amssullivan28]

Could be waiting for legislation changes:

https://www.tga.gov.au/therapeutic-goods-legislation-amendment-2019-measures-no1-regulations-2019https://www.tga.gov.au/therapeutic-goods-leg

Even competitors like Withings, Samsung and Fitbit have yet to have TGA approval for their smart watches with ECG apps.

 

[SaSaSushi]

Still waiting in AUSTRALIA!!!!! APPLE!!!!!! AUSTRALIA!!!!!

fixed that for ya.

Interesting, this.

Apparently Australia's medical regulator (TGA) claims Apple never applied to them for approval. Since Apple apparently refused to respond to Gizmodo Australia about this claim it's hard to know what the real deal is.

I hope you guys get it soon. I know I wasn't expecting to wait two years when I bought my Series 4.

 

[PickUrPoison]

Could be waiting for legislation changes:

Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019

This is the first package of regulatory changes for the broader medical device reforms

www.tga.gov.au

Even competitors like Withings, Samsung and Fitbit have yet to have TGA approval for their smart watches with ECG apps.

Nice! From a quick read February 2021(?) seems to be the implementation date for some recent reforms to regulations.

PS Your url is a little munged ?

 

[BootLoxes]

Thank god! Ive been waiting for this feature for so long.

I live in Japan, have a series 5 I bought here and the ECG app has been live since at least around the new year. It might have just gained official approval but it's been turned on for months.

Yeah no thats a lie. I have a jp iphone and jp series 5 and every time i try to activate it (just check a few seconds ago) it says this feature isnt available in my region.

 

[richard779]

Interesting, this.

Apparently Australia's medical regulator (TGA) claims Apple never applied to them for approval. Since Apple apparently refused to respond to Gizmodo Australia about this claim it's hard to know what the real deal is.

I hope you guys get it soon. I know I wasn't expecting to wait two years when I bought my Series 4.

I have heard in a number of sources Apple never apply the use to ECG for their watch with TGA. And I have emailed Apple a number of time a d also asked their WW Marketing and product development and no one will reply!!!

 

[insomniac86]

?Australia anyone.

Don’t hold your breath, but hopefully the recent changes to the legislation that was introduced in 1989 will accomodate this.

The Australian government is only fast at implementing draconian laws that make them bulk cash.