Dahua's body temperature system is now in Australia's medical device registry. However, Dahua used the wrong category - allowing it an "automatic entry" - while claiming their device has no temperature displays nor recording despite touting this feature widely.
In response, the Australian government tells IPVM it "will review" and may "take action", saying it has the power to cancel registrations and "issue fines or pursue criminal offence or civil penalty" related to illegal advertising.
This really is a crazy situation, we now have this issue where the TGA is requiring all devices to be registered and meet their standards even though they are not being used as a medical device. The issue is there is not one automatic device listed on the TGAR, if there were devices out there capable of meeting the TGA Class IIa regulation then surely they would have been registered by now.
This is partly driven by the US and EU largely moving to self regulation as well as other large markets being largely unregulated meaning that the manufacturers do not need to get certified under ISO13485 to sell out their full production. This means the pieces of junk are coming openly on the market with good devices and no one is able to tell what is what. Some of the devices I have tested give readings in the low/mid 35s.
Government red tape is stopping businesses being able to legally purchase these devices, and confusing the marketplace with all devices currently being sold illegally. There has to be a better path than this.
To be clear I am not defending Dahua's misleading actions, in fact this is part of the problem that businesses genuinely trying to do the right thing are compared to the Dahuas and handicapped by the system.
the TGA is requiring all devices to be registered and meet their standards even though they are not being used as a medical device.
#1, thanks for your comment. To clarify, these devices, like Dahua body temperature detection, are being used as a medical device, yes/no? They are being used to measure temperatures to look for fevers as a sign of coronavirus, that would be a medical purpose, no?
That's clearly the stance of the US FDA, the Australia TGA, etc., but I'd like to clarify if you think differently here? Thanks!.
Sorry new to this board and didn't post correctly.
I agree that it appears that all devices that measure body temperature the TGA is now deeming as Medical Devices that need Class IIa registration. The issue with this as I see it is that businesses and schools are wanting some sort of screening device to detect someone that may have a temperature and there is no product on the global market that is capable of meeting this need and meeting the requirements of a Class IIa product.
By extension of TGA's stance all products that are automated in Australia are illegal, during a pandemic this does not seem to be the right solution. This is not the TGA's issue either, they have legislation and guidelines that they have to implement.
What I was trying to say, not eloquently, was these businesses are not looking for a medical grade device, just something that fills the need. To do so under the current view point means that they have to buy a product that is illegal sold.
I am not an expert on the US but as I understand it the has found a pragmatic solution which provides companies with suggested guidelines during the pandemic. While in my mind this goes too far in allowing potentially poor devices onto the marketplace it at least allows the option in what is a quickly developing market with new products available daily.
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Comments (4)
Undisclosed Distributor #1
This really is a crazy situation, we now have this issue where the TGA is requiring all devices to be registered and meet their standards even though they are not being used as a medical device. The issue is there is not one automatic device listed on the TGAR, if there were devices out there capable of meeting the TGA Class IIa regulation then surely they would have been registered by now.
This is partly driven by the US and EU largely moving to self regulation as well as other large markets being largely unregulated meaning that the manufacturers do not need to get certified under ISO13485 to sell out their full production. This means the pieces of junk are coming openly on the market with good devices and no one is able to tell what is what. Some of the devices I have tested give readings in the low/mid 35s.
Government red tape is stopping businesses being able to legally purchase these devices, and confusing the marketplace with all devices currently being sold illegally. There has to be a better path than this.
To be clear I am not defending Dahua's misleading actions, in fact this is part of the problem that businesses genuinely trying to do the right thing are compared to the Dahuas and handicapped by the system.
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Undisclosed Distributor #1
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