Apple Watch ECG
Is Apple in Australia in the process of applying to allow the ECG app to be used in Australia? If so is there an ETA?
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Is Apple in Australia in the process of applying to allow the ECG app to be used in Australia? If so is there an ETA?
Read the following and judge for yourself
ECG Australia - TGA.gov.au documents on regulatory process, which mentions the Apple Watch
https://discussions.apple.com/thread/251220975?answerId=252347558022#252347558022
This is a user-to-user technical support site operated by Apple, no one is here that could answer your question and Apple executives wouldn't anyways. The last article I saw about the approval in Australia was not very promising about forthcoming approval.
I'm no lawyer (so don't hold this against me - just trying to be optimistic with my limited knowledge of law) but an amendment has been passed and received royal assent just recently (Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020). The amendments made do seem to cover possible adaptations to allow "the software" of an Apple Watch to act as a medical device. If it's good to go, let's hope that Apple are quick to make the registration with the TGA a priority so will it will be apart of our devices.
More info on the amendment: https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/Bills_Search_Results/Result?bId=r6507
Apple Watch ECG