Dahua Loses Australian Medical Device Approval

By Charles Rollet, Published Aug 04, 2020, 08:27am EDT

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'.

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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 ********

**** *****,**** ************ ***** *** ******* its ******* ******** ** Australia ******* *** ********* of *** *********** ***** Administration (***), *********'* ******* device *********, ******** ************* ******** ** ********** as ***** *** ("*** ** ******" ****) ******* ** the ********** ******* ****** database (****.)

********* *** ******, ***** successfully ********* *** ******* to *** ******* ** ** ******** wrongly ********* *** * ***** I ******:

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***** * ** *** lowest **** ******** ******** and********* **************** ********:

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

*****'* **** ******* ** ****** ********* online:

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*****, *** *** ********* to **** **** ***** had ********* *** **** entry ********* "***********" **** the *** **** *** "incorrect" ********:

**** **** ***** *** cancelled ** *** ******* [Dahua] ********* *********** **** the *** ********* *** incorrect ************** ** *** product ** *** ****.

*******, ***** **** ** no *******/**** *** ***** and **** *** ***** reapply:

***, *** ******* *** submit ** *********** *** inclusion ** *** ****, with *** *********** *****, being * ***** *** medical ******.

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

***** ****** **** *** fever ****** ******** ** Australia ***** ** **** proper ********* ** *** ARTG. *******, **** ***** take ******,*** *** ****- *** ***** *** devices, **% ** ************ are ********* ** ** working **** (***** * months) *** **% ** applications **** *** ******* days (***** * ******):

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******* ***** *** ******** requires *** **** **** for *** *** ** process *** **** * Conformity ********** **** *** **** ** ******** entities.

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

** *** **** ***** obtains ********, *** ******** may ** **** ***** with ****** *** ***** detectors. ***** *** **** and ***** ********, ** is ******* ** **** whether ***** **** ******** reapply *** **** *********.

** ***** *** *** if ***** ** **-******** and **** ******** ** comment, ********* ** ** Dahua. ***** *** *** respond ** *** ******* for *******.

Comments (18)

**** ** ******* *****? Honest ******* ** *****?

"*** * ***** **** gotten **** **** **, if ** *****'* *** those ******** **** ** IPVM!"

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*** ****** **** *** their ***** *** *** registration?

*** *** *** **** and ******** ***** ******* cameras ** **** ** tv.

*****://*******.***/********/******/*******************

** - ***** *** no ******* **** *** cameras ** ********* *********** readers. *** **** ************* device ** * ******** thermometer.

***** ***** **** ** me ** **** ******** and *** ***** ** disaster **** *** *** are *********** ******* ***** devices **** *** ******. I ********** **** ***** and ****** *** *********** things **** *** *** be **** *** ****** not ** ******* ** the ******.

***** *** ***** * lot ** ******* ** the ******, *** * do *** ***** *********** from *** *** ** far ****. ******* ** their *** ****** ************* I **** * ******* this ** *** ***** to *** ****....

******* ** ***** *** recall ************* * **** a ******* **** ** not ***** ** *** well....

#*, **** ****** ************* are *** ******** **? May *** *********?

*** *** ********** *** expedited ****** ******* *** all ************ *******. ******* between *** ***** **** may ******* *** ******* sold *** ** *** TGA ** ** ********. This ***** **** ******* out ***** ****** ****** in *** *******, *** without ** *********** ****** apart **** * **** expensive **** ** ****** a ********** ***** ** take ******* ************ ******** venues/workplaces ***** ****** **** not ** *** ** the ****. * *** not *** ** ******** that **** ** ***** to **** *** ******** effect ** ******** *** spread ** *** ***** here ** * ******** juncture.

********* ****** ****** *** faulty ** ************ *****-** devices | *********** ***** Administration (***)

***** *** ****** ** NCITs **** **** **************. Why ****** ** *********** device ** ******* ** the ****** **** ******* there's * ********? ******, exactly ******* *****'* * pandemic, ******** ****** ****** on ******* **** *** actually ******** *******? ** it's *** *********, **'* a ***.

***** ******** ****'* **** and **** ****** ** certifications ****** ****, *** reason **** *** *** available ** *** ********** market ** **** *** bar ***** ** ************* higher **** ***** *******. FDA *** ** *** allowing ******* ******* ***** self ********** *** ******* regulation ** **** *****. If *** **** ************* these ******** *** ******* out **** ********** ***** day ***** *** **** through ***** ** **** to *** ****** ********** market?

*** ****** ** ****** be ******* ***********, *** setting * *** ** high **** ** *** can **** ** ** helping ** ***.

** ***** ***** ******* have **** ****** * lot ****** *** ****** these ************** ** **** into *** ***** *******, therefore **** **** **** now.

*** *** **** **** medical ****** ******** ************** Dahua ****?

***** *** ****** ******* Solutions "******* ** ******* Devices"

** ****,

** ******** *** ***** all ***** ******* *** there - *** ***** specifically *** * ** not * *** ** for **** *******. ***** are * ****** ** other ******* *** ***** that **** **** ************** but ** *** **** the ******* ** *** TGA ** *********.

***** ** *** * automatic ****** ** *** market ******** *** ***** the ***'* ************. ***** there ** * **** demand **** ********* ****** to ** *** ***** thing ** * ********, Victoria ** ********* ** now ** *** ** the ********* (** *** the *********) ******* **** down ** *** *****.

********* **** *** ********** bar ** ** **** that ** *** *** meet ** ********* *** people **** *** *** selling *********** *******. * significant ****** ** ********* looking ** *** *** products ****** ** *** know *** *********** ** given **** *** *** find * ********** *********** end ** ****** * unregulated *******. ***** ******* are *** ********** *** all *** *******. ***** has ** ** * better ******* **** ****.

****, ** *** **** into * ******'* ******* and ** ****** *** a *** *********** *** used ** ** **** of *** *********, * suspect ***'* ** ***********. So *** *******'* ********* systems ** **** ** the **** ********* ** handheld *******? **** *** both ***** *** **** job *** ********** ** mitigate *** **** ****.

*******, ** ***** ** say **** *** *** does ****** **, ***, Japanese *** ******** ****** certifications. ** * ******* hasn't **** ********* ** any ** ***** ******* as * ******* ******, I'd **** ** **** not ** **** ** a ***.

* ***'* **** ****** else **** *** ***** IIa *** ************ ***. In ******** ** *********, the **** *** ****** is **** *** **, I ******* ****** **************** ***** ******** *** considered ******* ******* *** are ***** *** **** a *** **** ***** (the ************ *** ******* last ***** ** ** doesn't **** *** ******** issue ****).

* *** *** *** an ******** **** **** is ***** ** **** any ******** ****** ** stopping *** ****** ** the ***** **** ** a ******** ********.

*** ******** *** ** that *** ********* *** not **** ************* ********* as *** *** ******* and *** *** ** applied *********, **** ******** a ***** ***** ** public ******.

** ** ************'* **** profile ******** * *********** investment ** ******* ********* then ** *** ** safe ** ****** **** the **** ** ****** caused ** ********** ********* is ******* ****.

** *** ******** **** profile ** **** **** screening ** ****** ********* then **** **** ** not *** *** ** do **. ********* ** which ****** ** ***** you **** ** ** appears **** ** ** 81% ** ***** ******** do *** **** *** symptoms, ********* * ********* fever.********** ** '******' *****-** infection *** ** **** higher **** *******

********** * **** *** the ************ ******* *** recalled. *** ******* *** has ***** ** ** the ***** *****, ** dahua ********* ****** ** on *** * ***** 1 ******, ****** ** fined *** ***** ****** imported. * ******* *** possible **** ** ** per ****** & **** should ** ****** ** a ******* ** *** importers ** ** *** right *****.

* ***** - **** articulated #*

**** ****, ***** *** to ** ** ******** cost *** ***-********** ** there **** ** ** motivation ** ******

******: **** ***** *** TGA ******* ** *** recalled *** ***** ***** cams **** **** ******* been ****. *** *** said **, *** **** these ******** ****** ***** investigation:

***** ******** *** ***** investigation *** ** **** the *** ** ****** to **** ******* *******. Whether, *** ****, ********** action ** *********** **** depend ** *** ******* of *** *************.

**** **** ****** **** this ************* ** ********.

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