Ok, it’s now 04 July 2020.
So, when will ECG be released in Australia.
I upgraded my Apple Watch specifically to get ECG, promised by Apple at that time.
Who is responsible in the Medical profession here for this absurd level of procrastination, please tell me...
Apple Watch
Given the registration hasn't occurred the issue is hardly solved!
Interesting that Apple doesn't seem to be able to negotiate the relatively easy TGA registration process, especially since there exists what is known as a Global Medical Device Nomenclature code (recognised by the TGA) that covers the hardware and another that covers the software! Would hate to think it is just laziness on Apple's part or that they won't provide any details to TGA, which to be frank is usually less than the US and the same as the UK and EU.
For information, the relevant codes are below. Registration takes less than a day to complete the form and usually an answer is received within a couple of days.
Hardware
Name
Wearable multiple physiological parameter recorder
Definition
An electrically-powered, wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiograph, haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a local application (e.g., smartphone) or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).
Software
Name
Smartphone camera home cardiovascular monitoring application software
Definition
A software program designed for use in a smartphone/watch with a built-in camera to periodically measure, via transcutaneous optical reading, and display cardiovascular parameters (e.g., pulse wave, heart rate variability, SpO2, blood pressure, LVEDP) for assessment of cardiovascular function to assist diagnosis of disease (e.g., arrythmia, cardiac autonomic neuropathy); it may also be used to provide general lifestyle/fitness advice or during a controlled Valsalva manoeuvre to facilitate cardioversion of supraventricular tachycardia (SVT). This is a home-use device which may allow for remote communication of data with a clinician; it may in addition be used in a clinical setting.
Saw this morning on MacRumors site. https://eftm.com/2021/02/apple-watch-ecg-approval-australia-tga-artg-irregular-heart-rhythm-206412
Apple hasn't made an application to Therapeutics Goods Association in Australia.
They have mislead Aussies in Keynote presentation on Series 4. That was swiftly taken off Aussies websites.
It is clear Apple doesn't value Aussies health. Nearly 2 years since release no applications have been sent. Apple watch 6 for Aussies probably will have no added benefits. Please Apple went is beef with Australia.
The Australian regulatory agency has some of the world's most stringent requirements for what it classifies as medical devices. Unlike the heart rate monitor which is not classified in Australia as a medical device, because it is not diagnosing a disease, the ECG is classified as a medical device and is considered to be diagnosing disease, in this case, abnormal function of the heart.
Apple likely hasn't applied for approval in Australia, because Apple doesn't have the stringent research & proof required in Australia to register a medical device. It isn't a lack of care for the folks in Australia, it's the lack of ability to provide the proof required in the stringent requirements.
I have purchased a small ECG unit called a Kardia that works with an App on my iPhone, maybe Apple could see how that is allowed to be sold in Australia.
Pay attention and do a little research instead of just whining and you would understand that the Kardia, available in the US as well, functions differently than the ECG on the Watch! The Kardia functions per the AU regulatory agency's definition of an ECG monitoring device, however with only the two leads. The Kardia is reading the electromagnetic pulses of your heart's beating from the two points, the fingers of both hands, to establish its data.
The Watch isn't doing that, the back of the watch contains several sensors that detect light (photodiodes), along with green and infrared LEDs that emit light. It is reading the flashing of its LED lights hundreds of times per second, to calculate the number of times the heart beats each minute. The electrical impulses through the two points of contact, the wrist and the finger of the opposite hand on the digital crown are also used in the watch's determination of afib. This process isn't recognized by the Aussie authority.
Official reply just received from the Medical Devices Information Unit - Authorisation Branch of TGA:
”For a company to promote or supply a product for therapeutic use within Australia the product needs to be either included in the Australian Register of Therapeutic Goods or subject to a relevant exemption.
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 requirments of the regulations.
As advised in the previous email the TGA cannot provide information to third parties in respect to a company’s intentions to apply for entry in the ARTG.
As this is the case your questions may be best responded to by apple or their Australian distributors.”
(╯°□°）╯︵ ┻━┻
Yes Apple need to lodge an application. Let it be known, Apple have not done so and this fact has been relayed to the Australian public directly from the TGA to the media on multiple occasions. It is a failure on Apple’s side. I have even contacted the TGA myself personally and was also advised the same.
Okay, so what is known is Apple said they are trying to get it approved in all countries (Russia and South Korea were just added), it is approved in New Zealand, the TGA has publicly stated Apple has not applied and they don’t release details of discussions with companies, etc, etc. We also know the publications in Australia have reported that the TGA was going to release updates to their regulations on medical devices and delayed the release until Feb. 2021.
In that case you should buy the Withings. Their watch obviously uses different technology than Apple does which is why theirs has received approval under current TGA regulations. Apple is not going to design and build s completely different model for the Australian model. If the updates in the TGA regs due to be released in February 2021 still do not allow for the technology used in the Apple Watch to be approved at that time Apple can decide what they will do going forward. They sell other Withings products in their stores perhaps in Australia they will offer the Series 3 Apple Watch and the Withings ECG watch in their stores.
teraez wrote:
It’s really frustrating especially as apple are not transparent and specifically list that these features are NOT available in Australia. Me, like so many other people, have upgraded from other smart watch’s to an Apple Watch only to be let down.
I really hope they apply to the TGA soon.
You are correct that Apple does not discuss on-going negotiations (very few companies do, as that can negatively affect the outcome). NOTE: The TGA is not discussing it either, nor putting out periodic updates explaining why the Apple Watch has not been included as an accepted device. Apple is also not discussing negotiations for the other 150'ish counties in the world where ECG is not supported either, and those 150 countries are not issuing updates on the approval process either.
Apple does not advertise ECG in Australia. If you are reading media from other countries, or if your local press is mentioning ECG, that is not Apple's fault.
Apple does document what countries have ECG support. It is a big (HUGE) Internet, so that fact that you did not find this one items that is a "Hot Button" for some users is understandable. Here is the link to Apple Watch Feature Availability:
https://www.apple.com/watchos/feature-availability/#branded-ecg
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.
markjennc wrote:
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!!!
No. Your government finally got around to changing your laws, so that it was legal for Apple to enable ECG. Prior to February 2021, Apple could submit all it wanted to, it would never have passed your legal requirements for an ECG medical device.
So technically, your government made you wait more than 2 years, and Apple is just making you wait a month or so.
No, you had to wait 2 years for your government to work with Apple and change their regulations. It was a waste of time for Apple to apply if they knew it would be rejected, the regs were changed and published in late February 2021. Come on Australia, wake up, New Zealand has had this for 2 years!
iOS 14.5 and watchOS 7.4 have been released. Upgrade the iPhone first, then the Apple Watch.
It’s here in Australia with Apple Watch update 7.4 time to stop whinging.
It is your Health agency in Australia. Apple didn’t “promise” anything, they sold a Watch that can take a single axis ECG IF the government approves it and allows it. Last article I read speculating on the situation was saying they did not think that your government would ever approve the use.
Apple Watch: ECG In Australia
