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.
Not if companies like Epic & Gang have anything to say about it.
Fortunately in Australia, the judge has put Epic's parallel lawsuit against Apple on hold until the US case has finished!
Reread the thread. Follow the links. Everything points to your government dragging its feet.
Apple is not stupid. They want you to buy their products as much as any other part of the world.
There are many hoops that have to be jumped through before an official application can be filed.
Read the links to see what your government has bone to stop Apple.
Why would Apple apply when the current rules make it clear they would not be approved? And Gizmodo, nor most other people outside the top management of the TGA and Apple executives have any idea what has been discussed between them.
Hi Luca. A medical ECG will have up to 6 nodes to measure electrical activity. The Apple watch only has one. It it is never going to meet the TGA standard of a medical device. The TGA needs to be more flexible as other global regulators have been including the US, UK, Germany, Switzerland, NZ etc.
The ECG function on the Apple Watch doesn’t meet the standard of a medical device as it only has one node to measure electrical activity. Therein lies the problem. Should it be regulated by the TGA? If it is a medical
device or it claims health benefits, it should. Is the work around having consumers sign a waiver acknowledging that it is not a medical device? Does that create issues for Apple from a marketing perspective in other countries. How does that impact the TGA given it receives the majority of its funding from sponsors and manufacturers of medical devices.
Toyotaprado2003 wrote:
do we know when apple going to put in an application to the TGA Australia for the ECG function on the apple watch?
No, we do not. This is a user-to-user forum. Unless Apple makes an announcement, no one will know.
Paulfcdx wrote:
It’s bad for your brand when you disappoint customers, but it’s fatal when you make them angry.
While I supposed it's possible that people here have brands, it's not Apple. And, while we may disappoint your or make you angry, it wouldn't be because of any failure on our part to file anything with an Australian government agency. Apple doesn't read here for suggestions. If you want them to know your thoughts, use the appropriate channel:
And they will continue not doing so. If this is a problem for you vote with your wallet and move on. Or wait until February and see what happens. If you honestly think Apple has done nothing to get it approved and just decided to, for some crazy reason, sit back and do nothing then you absolutely should change brands. You would be crazy not to.
No, they have not applied. And given the current regulations if they did they would be turned down. Which would then solve your issue.
Have you ever been involved with trying to get a health authority to approve something? I have. Took 13 years.
I have no questions about it, I do have experience with situations like this and I've watched the approval process move on. Mark February on your calendar. And you might also want to go to New Zealand's health agency website and review their approval.
littlepiko wrote:
How do you know you will be rejected unless you do apply? Other watches monitor heart rate, why can’t you? Is it because you’re using wording such as “ecg?” Can you change this wording so Australian people can use all functions also? In as far as advertising, your ads mentions ecg monitoring. It should also state that this feature is not available in Australia. Can you answer question about sleep cycles ?
Because "Applying" is not the first step. There is an entire dance that has to happen before TGA will "Invite" Apple to "Apply", and the Apple Watch ECG cannot "Tango" they way TGA wants, so they are not being invited to "Apply".
And the TGA gets to say, "Gee, they didn't Apply", which is a half truth.
Read the following thread and follow the links
https://discussions.apple.com/thread/251220975?answerId=252347558022#252347558022
https://www.tga.gov.au/therapeutic-goods-legislation-amendment-2019-measures-no1-regulations-2019
No ECG on Apple watch in Australia until after Feb 2021
Yes, but Apple is yet to apply.
Apple has to apply ... and hasn't yet :-(
Apple Watch: ECG In Australia
