ECG - Apple Watch - Australia

Problem is the Therapeutic Goods Administration (TGA - https://www.tga.gov.au) in Australia.... Apple needs to make a submission for testing and it appears they have not done so.... I am really peeved about that as I bought the S4 when I had an S3 that was just fine..... I bought it solely for the ECG Feature being a 67yo male. TGA sees this as a health appliance and needs to be certified. Well.... Apple was able to do it in the USA with the FDA, UK, Canada, across Europe and now Hong Kong and Singapore. Hoipe Apple pulls its finger out and gets it done.

There are other ECG appliances available on the Australian market... Same type.. Single Wire ECG that allow people to monitor the heart issues. So hopefully Apple will get it done.

If it does not come in the September new wave of stuff may try to get a CL refund for failure to deliver as advertised.

Won't go as far as to say false advertising as Apple did say it would roll out in time... But I did check the ARTG (Australian Registry of Therapeutic Goods) and I find other ECG tools and appliance as well as health bars and Granola.... But no Apple Watch listed... NADA

Are you saying because other ECG equipment is approved the Apple Watch should be automatically approved? It doesn't work that way, the applicant has to request information from the approval agency on what the approval procedure is, what tests are required, etc., etc. The applicant then completes the steps required and submits preliminary information to the approval agency for review and answers any questions, submits more data, yada, yada, yada. If ARTG is like the FDA they really won't accept an application for approval until all the preliminary data has been submitted to their satisfaction then they invite the applicant to apply. But if anyone contacts the agency they will say the company hasn't applied.

what would apple gain by omitting it in some countries ?

this is a user helping other users with tech

questions forum, you are not addressing apple here just fellow users

anything you can get here are people best guess and vague knowledge

if you want apples ear https://getsupport.apple.com/

and or Feedback - Apple Watch - Apple

in these forums you will never get the first news of apples unofficial plans or insight into their plans and schedules

I'm sure if Apple had the approval from Australian health authorities they would have included it when they released it. You will eventually get it unless your agency refuses to certify it.

This is absolute crazy given the record overseas in USA and Europe of lives saved. We need an urgent parliamentary question on hurrying this up. Why should not this live saving and therefore financially cost effective health measure not be urgently implemented.

I’m sure Apple have had conversations with the TGA, just nothing on the record, similar to how they had early secretive talks with the FDA https://www.businessinsider.com.au/apple-secretly-meeting-with-fda-for-years-2016-11.

When Apple got FDA clearance for the Apple Watch ECG ‘app’, they magically circumvented the rules that apply to every other medical device manufacturer. They got FDA clearance for an ECG app only, not the Apple Watch or ECG electronics and electrodes built into the Apple Watch that actually measures the ECG, somehow blinding the FDA and other regulatory bodies.

Scott Gottlieb, former commissioner of the FDA explains that “The watch isn’t a medical device, just the apps that help consumers detect serious medical conditions”, and justifies the Apple Watch and ECG hardware being unregulated because the watch and it’s ECG measuring capability is a standard platform, like a phone or other computer.

https://twitter.com/sgottliebfda/status/1040273952067805185?lang=en

By this logic, medical device manufactures should be able to make an app that measures Blood Pressure, or Blood Glucose, or any other similar type of medical device, without the hardware component having to be included as part of the medical device and therefore not subjected to the usual manufacturing, safety, performance, and regulatory requirements, as long as the hardware is built into a ‘standard platform’ like a watch, phone, laptop etc.

Many others in the medical device industry have raised similar questions “It defies the laws of physics to describe an ECG device as anything but including electrodes and this new regulation that FDA has created which is now law defines ECG as software only and that is absolutely contrary to the laws of physics”

https://medtech.pharmaintelligence.informa.com/MT123322/FDAs-Speedy-Apple-Watch-De-Novos-Raise-Questions-For-Industry

I very much doubt it, but perhaps the TGA are not so easily wooed and taking time to consider the wider implications here? An ECG device that is an ‘app’ only contradicts their clear definitions of what constitutes a Software only Medical Device, so presumably they would have to make special exceptions for Apple to get TGA approval. Alternatively, Apple could be required to manufacture their Apple Watch under ISO 13485 and to have the Apple Watch with ECG hardware included as part of the medical device and subjected to the same regulatory review like every other ECG device manufacturer.

Not being sued for a non approved medical equipment in Australia. Simply that which they could be liable for without approval I assume if medical error or missed diagnosis was blamed on the watch ECG which of course given our litigious society inevitably some one or some situation would evolve which would lead to this outcome. Lets hope there is a way to get over this delay quickly as it would seem that lives are being saved overseas. AF is a major cause of strokes and the sooner it is detected and treated the better. This apple ECG is a great tool in preventing these complications.

That’s weird. I bought my Series 4 watch in Singapore while on holidays yet I registered it as an Australian which has blocked me from being able to use the ECG feature. Guess my point is that the watch wasn’t bound to anything based on its country of purchase.

this

is a user helping other users with tech questions forum, you are not addressing

apple here just fellow users

Apple Watch Series 4 Features availabilit… - Apple Community

Nope... Not saying that at all... Just saying does not appear that Apple has 1) either not submitted for certification, or 2) has not been approved hence not in the ARTG

Yes I would like to see the ECG for Australia.

I paid a fortune for my Series 4, and would expect to see the same features that the folks in the USA get as well.

Not happy that I paid a premium price for less.

What really makes me mad is that i bought my Apple Watch when i was on vacation in Perth this January. I am a Swiss citizien and my apple id is registred in Switzerland. I activated my Watch with Swiss credentials and still can not use the ECG because the firmware on the watch treats it like an australian apple watch.

I even opened a case with Apple support and they cant help me. So even if ECG is activated for Switzerland i have to wait until the Aussies get this feature.

Hi, how can i know if Apple applied a request to the Health authority?