Wrong Dahua Australia Medical Device Approved
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.
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 ******* ***** ********, ***** * ******* ** ***
** ***, *** ********** ******* ****** regulator, *** *********** ***** ************** (***),************* "**** *********** *********** *******" **** Class *** ******* ** ************* ******* ****** ********(****):
*******, ******** ** **** ******** ********,*****'* **** *****,***** ***** **** **, **** ***** device ** ***** *:
Class * ******* "****** ****", ********* *** "********* ********"
***** * ******* *** *** *******/******** to *** ** *** **** ** they **** *** ****** "***** ** ********* ****", **** ****** *******"*** ****** *** ********* ***** ** a ******* ******, *** **** **** need ** ** ******** *** *********". TGA ******** ** ***** * ******* include****** *************** ***** *** ******** ******* "******* or ******** ************":
*** "******* ******" ***** * *******, approval ** ********* "*********",*** *** ******,*** "***** ** ** ********** ** the ***********" ****** *** ***** **% of ********-******** ************:
******* *** ********** ** **** ***** IIa ******* ******* ********** * ********** Assessment **** *** **** ** ******** *************** ***** * ******* ** *** require **** (******* ********** ** "****-********" by *** ************.)
Dahua ****** ** **** *******
*****'* **** ***** **** ****** **** their ********* ****** "**** *** ******/******* or ******* *** ***********" ** ** individual, ******, "***** ******* **** ***** to ***" ** *******'* "*********** ** above * *** *****":
*******,**** *** ***********'* *********** ******** *** **** ******* people's **** *********** ** *.*°* **********. The***** ********* ********** *** ******* **** *********** ********** Solution **** ***** ******** **** "****-**** temperature *******":
*****'* *** ******* ********** ****:
************* ********* (*************** *****-*-**:****)******* **** ***** ******* ******* ************ within * ******* *.*°* *********:
** ** *** ***** ** ** why ***** **** **** ***** ** its ***********. ***** *** *** ******* to *** ** *** *********.
Dahua ********** ****** ************
*** *****, *** ***** **** ******* *********'* ***************** *********** *******:
*******, *****'* **** ***** **** ** only ********, ** **** **. *********** a ******* ****** **** ** *** on *** **** ** ******* ********** law, ************ ************** ***** *** ** ********* ******:
* ****** **** *** ******* ** broadcast ** ************* ***** *********** *****: (g) **** *** *** ******* ** the ********
*** *** ****** **** ********** ** this ****** ***** ********* *****, ********** ** * $*,*** **** today.
* *** ***** ***** ** ********* Dahua ***** ****, *** ***** **** of ***** *********'* ******* ** ****** showed *** **** **** *******. *******,*** **** ****** ** ***** ** as ** **** **.
Australia ********** **** "**** ******", *** "**** ******"
*** *** **** **** ** **** "review" *****'* **** ***** *** ******** the ***** ** "**** ******, ********* cancellation **** *** ****, ** ***********":
*** *** **** ****** ************* *** evidence **** *** ******* *** ************ to ******* *** ****** ****. ** will **** ******, ********* ************ **** the ****, ** ***********.
**** ** ***** ** *********** * product ******* ****** ************, *** *** told **** **** ** *** *** power ** "***** ***** ** ****** criminal ******* ** ***** ******* ***** action":
************** *** *********** ***** *** ******* to *** *********** ***** ***********, ********* the *********** ***** *** **** (*** Act). *** *** ********* *********** *********** goods ** ********* ** ***** ***** are *** ******* ** *** ********** Register ** *********** ***** (****) *** they *** *** ****** **** *** requirement ** ** ******* ** *** ARTG.
*** *** *** *** ******** ************ or ***** *********** ********* ******* ******* for ********** ****** ** ********* **** the **** ** ** ******* ** the ****. ** ****, ***** ***** of ******* *** **** ** ******** advertised ** ********* **** *** **** they *** ******* ** *** **** (e.g. *** *****, **** ** ** July ****).
***** *** ***, *** *** *** issue ***** ** ****** ******** ******* or ***** ******* ***** ****** ******* the ****** ** ******** *********** *** advertising ***** **** *** *** ******* in *** **** ***/** ** *** comply **** *** ***** *********** ***** advertising ************.
*** *** ** ********* *** ******* to ** ********** *** **** ***** standards **** ****** **** *** *** being **** ** * ******* ******.
#*, ****** *** **** *******. ** clarify, ***** *******, **** ***** **** temperature *********, *** ***** **** ** a ******* ******, ***/**? **** *** being **** ** ******* ************ ** look *** ****** ** * **** of ***********, **** ***** ** * medical *******, **?
****'******** *** ****** ** *** ** FDA, *** ********* ***, ***., *** I'd **** ** ******* ** *** think *********** ****? ******!.
***** *** ** **** ***** *** didn't **** *********.
* ***** **** ** ******* **** all ******* **** ******* **** *********** the *** ** *** ******* ** Medical ******* **** **** ***** *** registration. *** ***** **** **** ** I *** ** ** **** ********** and ******* *** ******* **** **** of ********* ****** ** ****** ******* that *** **** * *********** *** there ** ** ******* ** *** global ****** **** ** ******* ** meeting **** **** *** ******* *** requirements ** * ***** *** *******.
** ********* ** ***'* ****** *** products **** *** ********* ** ********* are *******, ****** * ******** **** does *** **** ** ** *** right ********. **** ** *** *** TGA's ***** ******, **** **** *********** and ********** **** **** **** ** implement.
**** * *** ****** ** ***, not **********, *** ***** ********** *** not ******* *** * ******* ***** device, **** ********* **** ***** *** need. ** ** ** ***** *** current **** ***** ***** **** **** have ** *** * ******* **** is ******* ****.
* ** *** ** ****** ** the ** *** ** * ********** it *** *** ***** * ********* solution ***** ******** ********* **** ********* guidelines ****** *** ********. ***** ** my **** **** **** *** *** in ******** *********** **** ******* **** the *********** ** ** ***** ****** the ****** ** **** ** * quickly ********** ****** **** *** ******** available *****.
.
**** ****** ** * ***** *********, we *** **** **** ***** ***** the *** ** ********* *** ******* to ** ********** *** **** ***** standards **** ****** **** *** *** being **** ** * ******* ******. The ***** ** ***** ** *** one ********* ****** ****** ** *** TGAR, ** ***** **** ******* *** there ******* ** ******* *** *** Class *** ********** **** ****** **** would **** **** ********** ** ***.
**** ** ****** ****** ** *** US *** ** ******* ****** ** self ********** ** **** ** ***** large ******* ***** ******* *********** ******* that *** ************* ** *** **** to *** ********* ***** ******** ** sell *** ***** **** **********. **** means *** ****** ** **** *** coming ****** ** *** ****** **** good ******* *** ** *** ** able ** **** **** ** ****. Some ** *** ******* * **** tested **** ******** ** *** ***/*** 35s.
********** *** **** ** ******** ********** being **** ** ******* ******** ***** devices, *** ********* *** *********** **** all ******* ********* ***** **** *********. There *** ** ** * ****** path **** ****.
** ** ***** * ** *** defending *****'* ********** *******, ** **** this ** **** ** *** ******* that ********** ********* ****** ** ** the ***** ***** *** ******** ** the ****** *** *********** ** *** system.