Dahua Loses Australian Medical Device Approval

By Charles Rollet, Published Aug 04, 2020, 08:27am EDT (Info+)

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'.

IPVM Image

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.

What ********

**** *****,**** ************ ***** *** ******* *** ******* solution ** ********* ******* *** ********* of *** *********** ***** ************** (***), Australia's ******* ****** *********, ******** ************* ******** ** ********** ** ***** IIa ("*** ** ******" ****) ******* ** *** ********** medical ****** ******** (****.)

********* *** ******, ***** ************ ********* its ******* ** *** ******* ** ** ******** ******* ********* *** * ***** * ******:

IPVM Image

***** * ** *** ****** **** category ******** ************ **************** ********:

IPVM Image

TGA ******** ************ *********

*****'* **** ******* ** ****** ********* ******:

IPVM Image

*****, *** *** ********* ** **** that ***** *** ********* *** **** entry ********* "***********" **** *** *** over *** "*********" ********:

**** **** ***** *** ********* ** the ******* [*****] ********* *********** **** the *** ********* *** ********* ************** of *** ******* ** *** ****.

*******, ***** **** ** ** *******/**** for ***** *** **** *** ***** reapply:

***, *** ******* *** ****** ** application *** ********* ** *** ****, with *** *********** *****, ***** * Class *** ******* ******.

Getting ******** ***** **** **** ******

***** ****** **** *** ***** ****** products ** ********* ***** ** **** proper ********* ** *** ****. *******, that ***** **** ******,*** *** ****- *** ***** *** *******, **% of ************ *** ********* ** ** working **** (***** * ******) *** 90% ** ************ **** *** ******* days (***** * ******):

IPVM Image

******* ***** *** ******** ******** *** only **** *** *** *** ** process *** **** * ********** ********** done *** **** ** ******** ********.

Will ***** **-*****? *******

** *** **** ***** ******* ********, the ******** *** ** **** ***** with ****** *** ***** *********. ***** the **** *** ***** ********, ** is ******* ** **** ******* ***** will ******** ******* *** **** *********.

** ***** *** *** ** ***** is **-******** *** **** ******** ** comment, ********* ** ** *****. ***** did *** ******* ** *** ******* for *******.

Update ****: ************* "******"

*** *** **** ** *** ****** its ************* ** ***** ******* ******* after ** ******* **** **** *** website:

**** **** *** ****** ********* *** TGA’s ****** ** *** *******. *** thermal ****** **** *** **** ******* and *** ******* *** ********* **** the *********** ************.

***** *** *** ******** *** *** fever ****** ********, ********* ** *** TGA's**** ******** ********.

Comments (22)

What do members think? Honest mistake by Dahua?

Agree
Disagree
Informative
Unhelpful
Funny

"And I would have gotten away with it, if it weren't for those meddling kids at IPVM!"

Agree
Disagree
Informative
Unhelpful
Funny: 13

IPVM Image

Agree
Disagree
Informative
Unhelpful
Funny: 1

Has anyone else got their class IIa TGA registration?

hik has run adds and promoted their thermal cameras as well on tv.

https://twitter.com/9NewsSyd/status/1263025888893063174

Agree: 1
Disagree
Informative
Unhelpful
Funny

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....

Agree: 1
Disagree
Informative
Unhelpful
Funny

Looking at their new recall notifications I have a feeling this is not going to end well....

#3, what recall notifications are you alluding to? May you elaborate?

Agree
Disagree
Informative
Unhelpful
Funny

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.

Expedited recall system for faulty or unauthorised COVID-19 devices | Therapeutic Goods Administration (TGA)

Agree
Disagree
Informative: 2
Unhelpful
Funny

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.

Agree: 3
Disagree
Informative
Unhelpful
Funny

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.

Agree
Disagree: 2
Informative
Unhelpful
Funny

Can you list what medical device external certifications Dahua have?

Dahua USA Admits Thermal Solutions "Qualify As Medical Devices"

Agree: 1
Disagree
Informative
Unhelpful
Funny

Hi Paul,

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.

Agree
Disagree: 1
Informative
Unhelpful
Funny

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.

Agree: 3
Disagree
Informative
Unhelpful
Funny: 1

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).

Agree
Disagree
Informative
Unhelpful
Funny

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.

One argument may be that the equipment has not been independently validated as fit for purpose and may not be applied correctly, thus creating a false sense of public safety.

If an organisation's risk profile warrants a significant investment in febrile screening then it may be safe to assume that the risk of damage caused by inaccurate screening is equally high.

Agree: 1
Disagree
Informative
Unhelpful
Funny

If the business risk profile is such that screening is deemed necessary then just temp is not the way to do it. Depending on which source or study you look at it appears that up to 81% of those infected do not show any symptoms, including a noticable fever. Prevalence of 'silent' COVID-19 infection may be much higher than thought

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.

Agree: 4
Disagree
Informative
Unhelpful
Funny

I agree - well articulated #4

Agree
Disagree
Informative
Unhelpful
Funny

Well said, there has to be an economic cost for non-compliance or there will be no motivation to comply

Agree
Disagree
Informative
Unhelpful
Funny

UPDATE: IPVM asked the TGA whether it has recalled the Dahua fever cams that have already been sold. The TGA said no, but that these products remain under investigation:

These products are under investigation and as such the TGA is unable to make further comment. Whether, and what, regulatory action is appropriate will depend on the outcome of the investigation.

IPVM will update when this investigation is complete.

Agree
Disagree
Informative: 3
Unhelpful
Funny

Any update?

Agree
Disagree
Informative: 1
Unhelpful
Funny

Thanks for the reminder, I've asked the TGA for an update - I'll update this piece upon response.

Agree
Disagree
Informative
Unhelpful
Funny

The case has been closed after Dahua removed the thermal cam, per the TGA:

This case was closed following the TGA’s review of the website. The thermal camera link has been removed and the website was compliant with the advertising requirements.

Dahua has not obtained any TGA fever camera approval, according to the TGA's ARTG approval database.

Agree
Disagree
Informative
Unhelpful
Funny

So typical useless Aust gov agency. No punishment for dahscums original LIES by trying to put the devices under the wrong classification.

Agree
Disagree
Informative
Unhelpful
Funny
Login to read this IPVM report.
Why do I need to log in?
IPVM conducts reporting, tutorials and software funded by subscriber's payments enabling us to offer the most independent, accurate and in-depth information.
Loading Related Reports