Dahua Loses Australian Medical Device Approval
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.
What ********
**** *****,**** ************ ***** *** ******* *** ******* solution ** ********* ******* *** ********* of *** *********** ***** ************** (***), Australia's ******* ****** *********, ******** ************* ******** ** ********** ** ***** IIa ("*** ** ******" ****) ******* ** *** ********** medical ****** ******** (****.)
********* *** ******, ***** ************ ********* its ******* ** *** ******* ** ** ******** ******* ********* *** * ***** * ******:
***** * ** *** ****** **** category ******** ************ **************** ********:
TGA ******** ************ *********
*****'* **** ******* ** ****** ********* ******:
*****, *** *** ********* ** **** that ***** *** ********* *** **** entry ********* "***********" **** *** *** over *** "*********" ********:
**** **** ***** *** ********* ** the ******* [*****] ********* *********** **** the *** ********* *** ********* ************** of *** ******* ** *** ****.
*******, ***** **** ** ** *******/**** for ***** *** **** *** ***** reapply:
***, *** ******* *** ****** ** application *** ********* ** *** ****, with *** *********** *****, ***** * Class *** ******* ******.
Getting ******** ***** **** **** ******
***** ****** **** *** ***** ****** products ** ********* ***** ** **** proper ********* ** *** ****. *******, that ***** **** ******,*** *** ****- *** ***** *** *******, **% of ************ *** ********* ** ** working **** (***** * ******) *** 90% ** ************ **** *** ******* days (***** * ******):
******* ***** *** ******** ******** *** 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**** ******** ********.
"*** * ***** **** ****** **** with **, ** ** *****'* *** those ******** **** ** ****!"
*** ****** **** *** ***** ***** IIa *** ************?
*** *** *** **** *** ******** their ******* ******* ** **** ** tv.
** - ***** *** ** ******* that *** ******* ** ********* *********** readers. *** **** ************* ****** ** a ******** ***********.
***** ***** **** ** ** ** this ******** *** *** ***** ** disaster **** *** *** *** *********** banning ***** ******* **** *** ******. I ********** **** ***** *** ****** are *********** ****** **** *** *** be **** *** ****** *** ** allowed ** *** ******.
***** *** ***** * *** ** devices ** *** ******, *** * do *** ***** *********** **** *** TGA ** *** ****. ******* ** their *** ****** ************* * **** a ******* **** ** *** ***** to *** ****....
******* ** ***** *** ****** ************* I **** * ******* **** ** not ***** ** *** ****....
#*, **** ****** ************* *** *** alluding **? *** *** *********?
*** *** ********** *** ********* ****** pathway *** *** ************ *******. ******* between *** ***** **** *** ******* all ******* **** *** ** *** TGA ** ** ********. **** ***** mean ******* *** ***** ****** ****** in *** *******, *** ******* ** alternative ****** ***** **** * **** expensive **** ** ****** * ********** nurse ** **** ******* ************ ******** venues/workplaces ***** ****** **** *** ** due ** *** ****. * *** not *** ** ******** **** **** is ***** ** **** *** ******** effect ** ******** *** ****** ** the ***** **** ** * ******** juncture.
***** *** ****** ** ***** **** have **************. *** ****** ** *********** device ** ******* ** *** ****** just ******* *****'* * ********? ******, exactly ******* *****'* * ********, ******** should ****** ** ******* **** *** actually ******** *******? ** **'* *** certified, **'* * ***.
***** ******** ****'* **** *** **** plenty ** ************** ****** ****, *** reason **** *** *** ********* ** the ********** ****** ** **** *** bar ***** ** ************* ****** **** other *******. *** *** ** *** allowing ******* ******* ***** **** ********** and ******* ********** ** **** *****. If *** **** ************* ***** ******** and ******* *** **** ********** ***** day ***** *** **** ******* ***** to **** ** *** ****** ********** market?
*** ****** ** ****** ** ******* unregulated, *** ******* * *** ** high **** ** *** *** **** it ** ******* ** ***.
** ***** ***** ******* **** **** around * *** ****** *** ****** these ************** ** **** **** *** these *******, ********* **** **** **** now.
*** *** **** **** ******* ****** external ************** ***** ****?
***** *** ****** ******* ********* "******* As ******* *******"
** ****,
** ******** *** ***** *** ***** devices *** ***** - *** ***** specifically *** * ** *** * fan ** *** **** *******. ***** are * ****** ** ***** ******* out ***** **** **** **** ************** but ** *** **** *** ******* of *** *** ** *********.
***** ** *** * ********* ****** on *** ****** ******** *** ***** the ***'* ************. ***** ***** ** a **** ****** **** ********* ****** to ** *** ***** ***** ** a ********, ******** ** ********* ** now ** *** ** *** ********* (if *** *** *********) ******* **** down ** *** *****.
********* **** *** ********** *** ** so **** **** ** *** *** meet ** ********* *** ****** **** the *** ******* *********** *******. * significant ****** ** ********* ******* ** buy *** ******** ****** ** *** know *** *********** ** ***** **** can *** **** * ********** *********** end ** ****** * *********** *******. These ******* *** *** ********** *** all *** *******. ***** *** ** be * ****** ******* **** ****.
****, ** *** **** **** * doctor's ******* *** ** ****** *** a *** *********** *** **** ** as **** ** *** *********, * suspect ***'* ** ***********. ** *** shouldn't ********* ******* ** **** ** the **** ********* ** ******** *******? They *** **** ***** *** **** job *** ********** ** ******** *** same ****.
*******, ** ***** ** *** **** the *** **** ****** **, ***, Japanese *** ******** ****** **************. ** a ******* ****'* **** ********* ** any ** ***** ******* ** * medical ******, *'* **** ** **** not ** **** ** * ***.
* ***'* **** ****** **** **** got ***** *** *** ************ ***. In ******** ** *********, *** **** you ****** ** **** *** **, I ******* ****** **************** ***** ******** *** ********** ******* devices *** *** ***** *** **** a *** **** ***** (*** ************ was ******* **** ***** ** ** doesn't **** *** ******** ***** ****).
* *** *** *** ** ******** that **** ** ***** ** **** any ******** ****** ** ******** *** spread ** *** ***** **** ** a ******** ********.
*** ******** *** ** **** *** equipment *** *** **** ************* ********* as *** *** ******* *** *** not ** ******* *********, **** ******** a ***** ***** ** ****** ******.
** ** ************'* **** ******* ******** a *********** ********** ** ******* ********* then ** *** ** **** ** assume **** *** **** ** ****** caused ** ********** ********* ** ******* high.
** *** ******** **** ******* ** such **** ********* ** ****** ********* then **** **** ** *** *** way ** ** **. ********* ** which ****** ** ***** *** **** at ** ******* **** ** ** 81% ** ***** ******** ** *** show *** ********, ********* * ********* fever.********** ** '******' *****-** ********* *** be **** ****** **** *******
********** * **** *** *** ************ devices *** ********. *** ******* *** has ***** ** ** *** ***** thing, ** ***** ********* ****** ** on *** * ***** * ******, should ** ***** *** ***** ****** imported. * ******* *** ******** **** is ** *** ****** & **** should ** ****** ** * ******* to *** ********* ** ** *** right *****.
**** ****, ***** *** ** ** an ******** **** *** ***-********** ** there **** ** ** ********** ** comply
******: **** ***** *** *** ******* it *** ******** *** ***** ***** cams **** **** ******* **** ****. The *** **** **, *** **** these ******** ****** ***** *************:
***** ******** *** ***** ************* *** as **** *** *** ** ****** to **** ******* *******. *******, *** what, ********** ****** ** *********** **** depend ** *** ******* ** *** investigation.
**** **** ****** **** **** ************* is ********.
****** *** *** ********, *'** ***** the *** *** ** ****** - I'll ****** **** ***** **** ********.
*** **** *** **** ****** ***** Dahua ******* *** ******* ***, *** the ***:
**** **** *** ****** ********* *** TGA’s ****** ** *** *******. *** thermal ****** **** *** **** ******* and *** ******* *** ********* **** the *********** ************.
***** *** *** ******** *** *** fever ****** ********, ********* ** *** TGA's**** ******** ********.
** ******* ******* **** *** ******. No ********** *** ******** ******** **** by ****** ** *** *** ******* under *** ***** **************.
**** ** ******* *****? ****** ******* by *****?