Wrong Dahua Australia Medical Device Approved

By Charles Rollet, Published Jul 20, 2020, 08:35am EDT

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.

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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.

Dahua also promoted the solution online prior to registering, despite the government prohibiting this, as IPVM exposed last month: Australia Dahua faked body temperature advertisement, with the Australian government warning of 'Criminal Offense' for not registering as a medical device.

Dahua ******* ***** ********, ***** * ******* ** ***

** ***, *** ********** medical ****** *********, *** Therapeutic ***** ************** (***),************* "**** *********** *********** devices" **** ***** *** devices ** ************* ******* ****** ********(****):

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*******, ******** ** **** explicit ********,*****'* **** *****,***** ***** **** **, says ***** ****** ** Class *:

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Class * ******* "****** ****", ********* *** "********* ********"

***** * ******* *** the *******/******** ** *** in *** **** ** they **** *** ****** "***** ** ********* ****", **** ****** *******"*** ****** *** ********* risks ** * ******* device, *** **** **** need ** ** ******** and *********". *** ******** of ***** * ******* include****** *************** ***** *** ******** include "******* ** ******** thermometers":

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*** "******* ******" ***** I *******, ******** ** typically "*********",*** *** ******,*** "***** ** ** assessment ** *** ***********" except *** ***** **% of ********-******** ************:

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******* *** ********** ** that ***** *** ******* require ********** * ********** Assessment **** *** **** ** ******** entities******* ***** * ******* do *** ******* **** (instead ********** ** "****-********" by *** ************.)

Dahua ****** ** **** *******

*****'* **** ***** **** claims **** ***** ********* device "**** *** ******/******* or ******* *** ***********" of ** **********, ******, "light ******* **** ***** to ***" ** *******'* "temperature ** ***** * set *****":

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*******,**** *** ***********'* *********** ******** *** they ******* ******'* **** temperature ** *.*°* **********. The***** ********* ********** *** ******* **** Temperature ********** ******** **** touts ******** **** "****-**** temperature *******":

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

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************* ********* (*************** *****-*-**:****)******* **** ***** ******* display ************ ****** * maximum *.*°* *********:

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** ** *** ***** to ** *** ***** made **** ***** ** its ***********. ***** *** not ******* ** *** of *** *********.

Dahua ********** ****** ************

*** *****, *** ***** page ******* *********'* ***************** *********** *******:

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*******, *****'* **** ***** went ** **** ********, on **** **. *********** a ******* ****** **** is *** ** *** ARTG ** ******* ********** law, ************ ************** ***** *** ** 1989***** ******:

* ****** **** *** publish ** ********* ** advertisement ***** *********** *****: (g) **** *** *** entered ** *** ********

*** *** ****** **** violations ** **** ****** incur ********* *****, ********** ** * $9,320 **** *****.

* *** ***** ***** we ********* ***** ***** this, *** ***** **** of ***** *********'* ******* no ****** ****** *** body **** *******. *******,*** **** ****** ** still ** ** ** July **.

Australia ********** **** "**** ******", *** "**** ******"

*** *** **** **** it **** "******" *****'* ARTG ***** *** ******** the ***** ** "**** action, ********* ************ **** the ****, ** ***********":

*** *** **** ****** documentation *** ******** **** the ******* *** ************ to ******* *** ****** made. ** **** **** action, ********* ************ **** the ****, ** ***********.

**** ** ***** ** advertising * ******* ******* proper ************, *** *** told **** **** ** has *** ***** ** "issue ***** ** ****** criminal ******* ** ***** penalty ***** ******":

************** *** *********** ***** are ******* ** *** therapeutic ***** ***********, ********* the *********** ***** *** 1989 (*** ***). *** Act ********* *********** *********** goods ** ********* ** those ***** *** *** entered ** *** ********** Register ** *********** ***** (ARTG) *** **** *** not ****** **** *** requirement ** ** ******* in *** ****.

*** *** *** *** exempted ************ ** ***** temperature ********* ******* ******* for ********** ****** ** Australia **** *** **** to ** ******* ** the ****. ** ****, these ***** ** ******* can **** ** ******** advertised ** ********* **** the **** **** *** entered ** *** **** (e.g. *** *****, **** is ** **** ****).

***** *** ***, *** TGA *** ***** ***** or ****** ******** ******* or ***** ******* ***** action ******* *** ****** or ******** *********** *** advertising ***** **** *** not ******* ** *** ARTG ***/** ** *** comply **** *** ***** therapeutic ***** *********** ************.

Comments (4)

Undisclosed Distributor #1

07/22/20 05:12am

**** ****** ** * crazy *********, ** *** have **** ***** ***** the *** ** ********* all ******* ** ** registered *** **** ***** standards **** ****** **** are *** ***** **** as * ******* ******. The ***** ** ***** is *** *** ********* device ****** ** *** TGAR, ** ***** **** devices *** ***** ******* of ******* *** *** Class *** ********** **** surely **** ***** **** been ********** ** ***.

**** ** ****** ****** by *** ** *** EU ******* ****** ** self ********** ** **** as ***** ***** ******* being ******* *********** ******* that *** ************* ** not **** ** *** certified ***** ******** ** sell *** ***** **** production. **** ***** *** pieces ** **** *** coming ****** ** *** market **** **** ******* and ** *** ** able ** **** **** is ****. **** ** the ******* * **** tested **** ******** ** the ***/*** ***.

********** *** **** ** stopping ********** ***** **** to ******* ******** ***** devices, *** ********* *** marketplace **** *** ******* currently ***** **** *********. There *** ** ** a ****** **** **** this.

** ** ***** * am *** ********* *****'* misleading *******, ** **** this ** **** ** the ******* **** ********** genuinely ****** ** ** the ***** ***** *** compared ** *** ****** and *********** ** *** system.

John Honovich

IPVM | In reply to Undisclosed Distributor #1 | 07/22/20 10:59am

*** *** ** ********* all ******* ** ** registered *** **** ***** standards **** ****** **** are *** ***** **** as * ******* ******.

#*, ****** *** **** comment. ** *******, ***** devices, **** ***** **** temperature *********, *** ***** used ** * ******* device, ***/**? **** *** being **** ** ******* temperatures ** **** *** fevers ** * **** of ***********, **** ***** be * ******* *******, no?

****'******** *** ****** ** the ** ***, *** ********* ***, etc., *** *'* **** to ******* ** *** think *********** ****? ******!.

Undisclosed Distributor #1

In reply to John Honovich | 07/22/20 11:30am

***** *** ** **** board *** ****'* **** correctly.

* ***** **** ** appears **** *** ******* that ******* **** *********** the *** ** *** deeming ** ******* ******* that **** ***** *** registration. *** ***** **** this ** * *** it ** **** ********** and ******* *** ******* some **** ** ********* device ** ****** ******* that *** **** * temperature *** ***** ** no ******* ** *** global ****** **** ** capable ** ******* **** need *** ******* *** requirements ** * ***** IIa *******.

** ********* ** ***'* stance *** ******** **** are ********* ** ********* are *******, ****** * pandemic **** **** *** seem ** ** *** right ********. **** ** not *** ***'* ***** either, **** **** *********** and ********** **** **** have ** *********.

**** * *** ****** to ***, *** **********, was ***** ********** *** not ******* *** * medical ***** ******, **** something **** ***** *** need. ** ** ** under *** ******* **** point ***** **** **** have ** *** * product **** ** ******* sold.

* ** *** ** expert ** *** ** but ** * ********** it *** *** ***** a ********* ******** ***** provides ********* **** ********* guidelines ****** *** ********. While ** ** **** this **** *** *** in ******** *********** **** devices **** *** *********** it ** ***** ****** the ****** ** **** is * ******* ********** market **** *** ******** available *****.

Undisclosed Distributor #1

07/22/20 11:12am

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