It’s illegal to sell a smart watch with a heart-monitoring and testing feature (known as ECG) in Australia without first being approved by the country’s medical devices regulator. But that hasn’t stopped some retailers trying.
Smart watches have become little health monitoring machines over the past few years, offering new features like heart and sleep monitoring. As smart devices move closer to becoming a portable Web MD service, regulators have responded by treating them as medical devices.
In Australia, it’s meant that some features, like the ECG heart-monitoring tool, need to first go through stringent testing. And it’s something no smart watch provider has managed to do just yet.
The Therapeutic Goods Administration (TGA) is the authority in charge of sorting this out in the country. If a company, like Apple, wants to include a feature like the ECG on one of their smart watch releases, it needs to apply to be included on the TGA’s Australian Register of Therapeutic Goods (ARTG).
Only then can it be advertised, supplied and sold to the Australian public. If it doesn’t, it can’t be legally supplied or sold here.
It’s a step the major smart watch providers, Apple, Samsung and Fitbit, have yet to do with existing legislation. Notably, Apple announced the feature back in 2018 and despite releasing three watches since, it still hasn’t gotten the feature approved with the TGA.
Some Australian retailers are selling ECG smart watches but the legality isn’t so clear
Despite the lack of success the major tech providers have had getting through regulatory approvals, online retailers are managing to sneak by. Australia Post, for example, is selling a Thomson smart watch it claims has the ECG feature.
It’s called the “Thomson Smart Watch ECG Monitoring” and its features include “monitor your ECG/Blood Pressure, Heart Rate”. No other major retailer in Australia appears to be stocking it.
Australia Post denied any wrongdoing, explaining it had been advised by the watch’s supplier it did not need the TGA’s approval.
“Our supplier has advised the Thompson Smart Watch ECG – Models DW1401 and DW 7301 are not classified as medical devices and are not meant for diagnosis or treatment,” a spokesperson for Australia Post said in a statement to Gizmodo Australia.
“The watches are classified as general health and fitness devices.”
But the criteria doesn’t appear to be clear. The TGA told Gizmodo Australia athat based on the limited information the site provides, it was undertaking an investigation into the product and Australia Post’s supply of it.
“It appears the Thomson watch with ECG monitoring functionality is a medical device and is therefore required to be included on the Australian Register of Therapeutic Goods (ARTG) prior to the watch’s importation and supply,” a TGA spokesperson told Gizmodo Australia.
“It is a criminal offence to supply or advertise a medical device that is not included on the ARTG.”
But Australia Post’s ECG smart watch wasn’t the only one available online for purchase in Australia.
A quick search of Kogan’s online store revealed a number of watches claiming to have ECG functionality from third-party resellers. None of these brands appeared in the ARTG.
Kogan said it intended to respond to our questions but did not provide a statement before publication. It’s since removed any mention of ECG watches from its online store. But you can still view the cached version here.
Buying an ECG smart watch might be possible in Australia but its claims haven’t been tested
While it might be tempting to buy a watch with the ECG feature, despite not technically being legal, it’s not without its risks.
Without that TGA testing, there’s no guarantee the watch is doing what it says it is. If you’re relying on it to give you accurate readings, you might be left disappointed or, worse yet, in danger.
Instead, the regulatory authority insists if you come across a site selling one of these watches, it’s best to report it to make sure nobody’s getting duped.
“Any products that are brought to the TGA’s attention, will be investigated and appropriate action taken in relation to any illegal supply or advertising of therapeutic products,” the TGA said.
“We encourage anyone with concerns in relation to COVID-19 related claims being made about a therapeutic good to provide information via the online advertising complaint form.”
There might be hope for ECG fans on the horizon. While it’s not entirely clear why no major smartwatch provider has gotten TGA approval for the ECG feature, upcoming amendments to the regulation might soon make the process easier. Right now, that’s been delayed until at least February next year while the authority focuses more intently on COVID-19 regulatory challenges.
Whether a mountain of ECG watches will suddenly flood the Australian market when that happens remains to be seen but it’s a promising step forward for many.