Dahua has cancelled its medical device registration after "discussions" with the Australian government less than 2 weeks after IPVM exposed Dahua had applied under the wrong category, allowing it 'automatic entry'.
The Australian government confirmed to IPVM that the category Dahua filed under was "incorrect", however, Dahua can still reapply but only under the correct category, which can take months. In the meantime, Dahua is not legally allowed to advertise or sell these devices in Australia, though it had already run a full-page advertisement in the Australian.
No - there are no devices that are cameras or automatic temperature readers. The most sophisticated device is a handheld thermometer.
Seems crazy that to me in this pandemic and now state of disaster that the TGA are effectively banning these devices from the market. I understand that Dahua and others are advertising things that can not be done and should not be allowed on the market.
There are still a lot of devices on the market, but I do not think enforcement from the TGA is far away. Looking at their new recall notifications I have a feeling this is not going to end well....
TGA has introduced new expedited Recall pathway for all unauthorised devices. Reading between the lines they may require all devices sold not on the TGA to be recalled. This could mean ripping out every thermo camera in the country, all without an alternative option apart from a very expensive cost of paying a registered nurse to take peoples temperatures entering venues/workplaces which people will not do due to the cost. I can not see an argument that this is going to have any positive effect on stopping the spread of the virus here in a critical juncture.
There are plenty of NCITs that have certifications. Why should an uncertified device be allowed on the market just because there's a pandemic? Surely, exactly because there's a pandemic, everyone should insist on devices that are actually accurate devices? If it's not certified, it's a toy.
These products aren't toys and have plenty of certifications behind them, the reason they are not available on the Australian market is that the bar there is significantly higher than other regions. FDA and EU are allowing devices through basic self assessment and minimal regulation at this stage. If you were manufacturing these products and selling out your production every day would you jump through hoops to sell to the little Australian market?
Not saying it should be totally unregulated, but setting a bar so high that no one can jump it is helping no one.
On NCITs these devices have been around a lot longer and needed these certifications to sell into all these markets, therefore they have them now.
My comments are about all other devices out there - not Duhua specifically who I am not a fan of for many reasons. There are a number of other devices out there that have many qualifications but do not meet the hurdles of the TGA in Australia.
There is not a automatic device on the market globally the meets the TGA's requirements. While there is a huge demand from companies trying to do the right thing in a pandemic, Victoria in Australia is now in one of the strictest (if not the strictest) current lock down in the world.
Naturally when the regulation bar is so high that no one can meet it companies and people fill the gap selling unregulated product. A significant number of companies looking to buy the products either do not know the regulations or given they can not find a registered alternative end up buying a unregulated product. These devices are now everywhere and all are illegal. There has to be a better outcome than that.
Well, if you went into a doctor's surgery and he pulled out a toy thermometer and used it as part of his diagnosis, I suspect you'd be unimpressed. So why shouldn't automatic systems be held to the same standards as handheld systems? They are both doing the same job and attempting to mitigate the same risk.
Equally, it seems to say that the TGA does accept EU, FDA, Japanese and Canadian market certifications. If a product hasn't been certified in any of these markets as a medical device, I'd find it hard not to call it a toy.
I can't find anyone else that got Class IIa TGA registration yet. In fairness to Hikvision, the link you shared is from May 20, I believe the TGA announcement that these products are considered medical devices and are Class IIa came a few days later (the announcement was updated last month so it doesn't show the original issue date).
Personally I hope all the unaccredited devices are recalled. Any sponsor who has tried to do the wrong thing, eg dahua Australia trying it on for a class 1 device, should be fined for every device imported. I believe the possible fine is 9K per device & this should be levied as a warning to all importers to do the right thing.