Apple Watch: ECG In Australia

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.

https://www.google.com.au/amp/s/www.macrumors.com/2021/03/03/apple-watch-ecg-approval-australia/amp/

Close, hopefully 7.4 release

The only facts that can be established are that the ECG function of the series 4 through 6 models of the Watch has not yet been approved for use in Australia. The function exists in the watches sold in Australia, but it cannot yet be activated by an upgrade/update to watchOS. Why the function hasn't yet been approved for use in Australia is currently unknown because the situation between Australia's authorizing body and Apple, Inc is a confidential matter between the two entities.

Period.

Nothing more is established fact.

I do acknowledge those facts. No head in the sand, no blinkers here.

Reply from TGA Feb2021

Unless exempt or otherwise authorised by the TGA, therapeutic goods lawfully supplied in Australia must appear as an entry in the Australian Register of Therapeutic Goods  (ARTG) when a manufacturer starts claiming that their product(s) are intended to be used for any of the following: diagnosis, prevention, monitoring, treatment, alleviation or compensation for disease or disability.

Monitoring of heart rate on its own is not considered to be monitoring of the disease, however if the manufacturer claims that the product monitors heart problems then the product will become a medical device.

If Apple claims the ECG function in its Apple Watch has therapeutic benefit for wearers, the watch would need to be included in the Australian Register of Therapeutic Goods (ARTG) in order to be legally supplied in Australia. The TGA is unable to compel a sponsor to submit an application to register a product and approval for marketing in Australia cannot be given in the absence of an application.

Sponsors must apply to the TGA for their medical devices to be included in the ARTG. As the minimum requirement, sponsors must have evidence that the manufacturer has applied appropriate conformity assessment procedures to their product. The sponsor also must have evidence that their medical device complies with the requirements for essential principles of safety and performance.

Due to confidentiality the TGA does not disclose information about current applications, and cannot advise whether an application has been received or is in progress. The information that the TGA can lawfully provide about a product is publicly available on the TGA website.

You may wish to contact the sponsor or manufacturer for further information about their intentions to submit an application to the TGA for registration of this product.

Yours sincerely

Regulatory Assistance Service

Regulatory Guidance, Assistance and SME Section

Regulatory Engagement, Education and Planning Branch

Phone: 1800 020 653 Fax: 02 6203 1605

Email: info@tga.gov.au

Therapeutic Goods Administration

Department of Health

PO Box 100

Woden ACT 2606 Australia

www.tga.gov.au

Government regulations for medical device approvals is TGA in Australia. As recent as July 2020 no application has been made by Apple to have ECG function registered for use. Considering Australia has heart disease as a leading cause of death. I doubt anything that could give an early warning wouldn't be approved. New Zealand approved it within months of an application. Apple doesn't seem to care about aussies 💕

As noted above, Apple is powerless to move the Australian government. You, on the other hand, have that power. Write to your Representatives in Canberra. Tell them that you want their help getting TGA and Apple to reach an agreement. If enough Aussies ask for help moving this forward, some help might be forthcoming. Good luck.

My guess from having worked in the electronics engineering field is Apple looked at the requirements to get it certified there. They saw there was no way as Australia has it written that the watch would be approved. Why submit something you know won’t be approved. Would be a waste of effort , time, and money. It would cost a lot of money to lobby the government to change the regulations probably more than they could recover from sales. We are not Apple employees and have no control over any company policies we just help where we can. If you want this change made you need to petition the TGA to change the rules. The ball is in your head court. Good luck.

Apple is not powerless. All they have to do is apply to the Therapeutic Goods Administration (TGA). as stated by a TGA spokesperson, “If Apple claims the ECG function in its Apple Watch has therapeutic benefit for wearers, the watch would need to be included in the ARTG in order to be legally supplied in Australia.”

The TGA has been questioned about this by the Australian community and has released this statement, “TGA has not received any applications for products manufactured and/or supplied by Apple, nor is there any Apple device included on the ARTG.”

Australian tech media has questioned Apple about this, and so far they have declined to comment.

Australia has stringent health laws to protect their community. It is most likely that the Apple Watch does not meet these standards and Apple want to avoid the humiliation of failing the test.

The Australian Therapeutic Goods Administration (TGA) is not the ones dragging their feet. They are yet to receive an application from Apple and have issued a public statement regarding this.

“If Apple claims the ECG function in its Apple Watch has therapeutic benefit for wearers, the watch would need to be included in the ARTG in order to be legally supplied in Australia.”

TGA spokesperson, June 2020.

From June 2020 article.................

“If Apple claims the ECG function in its Apple Watch has therapeutic benefit for wearers, the watch would need to be included in the ARTG in order to be legally supplied in Australia,” a TGA spokesperson said to Gizmodo Australia.

“TGA has not received any applications for products manufactured and/or supplied by Apple, nor is there any Apple device included on the ARTG.”

The Australian Register of Therapeutic Goods (ARTG) is a list showing which goods can be lawfully sold in the country. If a company intends to sell a medical or therapeutic product it needs to apply through the TGA for it to be legally sold. This is to stop snake oil salesmen fabricating medical products without governmental oversight.

Gizmodo Australia asked Apple to confirm why it is yet to put the devices on the register but it declined to comment. It also declined to comment on whether it has ever started this process.

You are not addressing Apple here. This is a user to user support forum and Apple does not participate here. If you wish to provide feedback to Apple regarding a change you would like to see, or report a bug, then use the feedback link here, Feedback - Apple Watch - Apple All we as users can say is go ahead and vote with your feet. Since Apple needs approval from the Australian government for ECG and have not received it, then you cannot use ECG on the Watch.

Apple promotes features that are available on all of their devices, and is footnoted that they may not be available in all regions. These is also a document with information of all features of iOS, as well as one for watchOS and it lists the features and what country the features are available in.

Also, you are not addressing Apple here, so your statement "you Apple keep promoting it" and "Your advertising" is not about us. This is a user to user support forum and Apple does not participate here. If you wish to provide feedback to Apple regarding a change you would like to see, or report a bug, then use the feedback link here,Feedback - Apple Watch - Apple

Do you have any actual evidence for your assertion that Apple hasn't made an application to the TGA?

If you read this comment regarding an investigation by Pickr: https://www.pickr.com.au/qa/2020/whats-happening-with-ecg-watches-in-australia/ you will see that the TGA considers applications for approval of medical products to be confidential business matters, which means that no-one except the TGA knows if and when Apple lodged an application for approval of the ECG feature on Apple Watches.

Logically, Apple must have lodged a TGA application in Australia. Why would they not when they have already they have already lodge successful applications in the US, Canada, the UK, most of Western and Eastern Europe, and numerous other countries - not to mention our neighbour, NZ? To say that they wouldn't have applied for the same approval at the same time here in Oz makes no sense.

If you need to blame someone, blame the Australian Medical Association and its medical specialists who are presumably demanding more extensive testing of the ECG feature in Oz - or completely blocking it for some inexplicable (but probably financial) reason.

Oh, and BTW, it's the Therapeutic Goods Administration - not the "Therapeutics Goods Association."

Looks like Apple now has TGA approval for Irregular Rhythm Notification feature as that is now listed in the ARTG:

https://bit.ly/3jsq5pR

Still no sign of ECG approval though.