pmoeser

Hi John,

I agree, it is outrageous that the watch isn’t included on the ARTG. I’ll come back to this point. 

Those entries are only as sponsors for a product be included in the ARTG. That’s a reasonably easy thing to do and they are for ‘simple’ products, probably considered Class 1 or low risk. Gloves and masks to use outside their stores. 

The watch is complicated software dealing with heart readings and as such is considered high risk by the TGA. 

However, in my company’s dealings with the TGA, they are just a bunch of academics who do literature reviews of published papers. They are not experts in the medical field. That is why most of their decisions leave people scratching heads. 

They will have instructed Apple to provide them with multiple peer reviewed studies of thousands of case reports and double blinded randomised studies. i.e. give people watches that don’t work as well as people with with watches that do. 

Hundreds of anecdotal stories about lives saved aren’t good enough. Unfortunately...

Being a high risk person for a-fib I need this feature. 

jcbigears said:

Just practicing my email:

Dear Tim,

Please make the ECG feature available to Australians.

Your company has registered devices with the Australian Register of Therapeutic Goods already https://bit.ly/3h2tZnt

The ARTG accepts evidence from overseas regulators including FDA, Health Canada, European Union and Japan https://bit.ly/3kObtkR

Please?

Thanking you,

John