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I want to register IVDs (CE) in Australia
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I want to register IVDs (CE) in Australia
I want to register IVDs (CE) in Australia
I want to register IVDs (CE) in Australia
I want to register IVDs (CE) in Australia
I want to register IVDs (CE) in Australia
I want to register IVDs (CE) in Australia
I want to register IVDs (CE) in Australia
I want to register IVDs (CE) in Australia
I want to register IVDs (CE) in Australia
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I want to register IVDs (CE) in Australia


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Some Related Topic Tags
australia, germany, ghtf (global harmonization task force), medical device registration, medical device standards and regulations, tga (therapeutic goods administration), ivd (in vitro diagnostic) devices and reagens, sted (summary technical documents)
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  Post Number #1  
Old 28th February 2012, 10:56 AM
AbsoluteBeginner

 
 
Total Posts: 14
Please Help! I want to register IVDs (CE) in Australia

Hello-
we (german Company) want to register IVDs in Australia an i wonder how it works? It's my fist Job in "Regulatory Affairs", so i'm quite clumsy. I know that i have to submit a technical File. And i read about the GHTF. Can i just create a technical file like the STED? Is it a common procedure?
We develope the IVDs under consideration of certain DIN EN ISO. Do the Australiens have specific Standards which i have to take account?

Thank a lot in advance!!

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  Post Number #2  
Old 28th February 2012, 12:16 PM
lilybef's Avatar
lilybef

 
 
Total Posts: 18
Re: I want to register iVDs (CE) in Australia

A sponsor located in Australia is the only entity that can register products with the TGA. The manufacturer cannot do the registration unless they are located in Australia. The TGA website http://www.tga.gov.au/industry/devices.htm is extremely well organized and will have most of the information you are looking for, including what needs to be included in the submission. They do use the STED documentation format for submissions. Good Luck!
Thanks to lilybef for your informative Post and/or Attachment!
  Post Number #3  
Old 29th February 2012, 04:23 AM
AbsoluteBeginner

 
 
Total Posts: 14
Re: I want to register IVDs (CE) in Australia

Thank you
  Post Number #4  
Old 1st March 2012, 12:14 AM
Ronen E

 
 
Total Posts: 3,736
Re: I want to register IVDs (CE) in Australia

Quote:
In Reply to Parent Post by AbsoluteBeginner View Post

Hello-
we (german Company) want to register IVDs in Australia an i wonder how it works? It's my fist Job in "Regulatory Affairs", so i'm quite clumsy. I know that i have to submit a technical File. And i read about the GHTF. Can i just create a technical file like the STED? Is it a common procedure?
We develope the IVDs under consideration of certain DIN EN ISO. Do the Australiens have specific Standards which i have to take account?

Thank a lot in advance!!
Hi,

If your devices are already EC certified / duly CE marked then you may not have to submit a technical file. For full details you may consult the TGA's guidance document on medical devices:

http://www.tga.gov.au/industry/devices-argmd.htm

If you require closer assistance please drop me a private message. I'm located in Australia and have gone through sponsoring / "registration" of medical devices in Australia (actually it's called "inclusion" here).

Good luck,
Ronen.
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