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Image Viewer Classification in Australia (Software Image Processing similar to PACS)
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Image Viewer Classification in Australia (Software Image Processing similar to PACS)
Image Viewer Classification in Australia (Software Image Processing similar to PACS)
Image Viewer Classification in Australia (Software Image Processing similar to PACS)
Image Viewer Classification in Australia (Software Image Processing similar to PACS)
Image Viewer Classification in Australia (Software Image Processing similar to PACS)
Image Viewer Classification in Australia (Software Image Processing similar to PACS)
Image Viewer Classification in Australia (Software Image Processing similar to PACS)
Image Viewer Classification in Australia (Software Image Processing similar to PACS)
Image Viewer Classification in Australia (Software Image Processing similar to PACS)
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canada, class i medical device, class ii medical device, european union, european union regulations and standards, fda (food and drug administration), fda classification, medical device listing codes and classifications, medical device software, software (general topics), tga (therapeutic goods administration), tga classification, medical devices
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  Post Number #1  
Old 13th June 2012, 12:24 PM
cmeby

 
 
Total Posts: 26
Please Help! Image Viewer Classification in Australia (Software Image Processing similar to PACS)

Hello
I am wondering if anyone can clarify for me the proper classification of a device that is :
Software Image Processing - similar to PACS
In Canada - Class II - diagnostic quality viewer with measuring
In FDA - Class II - diagnostic quality viewer
In Europe - Class I with measuring function

I am confused with the TGA classification.
Thinking it is Class I measuring, like Europe.....but auditor thinks it may be Class IIa.

Any help would be great!!

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  Post Number #2  
Old 13th June 2012, 07:17 PM
Ronen E

 
 
Total Posts: 3,736
Re: Image Viewer Classification in Australia (Software Image Processing similar to PA

Quote:
In Reply to Parent Post by cmeby View Post

Hello
I am wondering if anyone can clarify for me the proper classification of a device that is :
Software Image Processing - similar to PACS
In Canada - Class II - diagnostic quality viewer with measuring
In FDA - Class II - diagnostic quality viewer
In Europe - Class I with measuring function

I am confused with the TGA classification.
Thinking it is Class I measuring, like Europe.....but auditor thinks it may be Class IIa.

Any help would be great!!
Hi,

In general, Australian medical devices regulation is similar to the EC's.

You can refer to the ARGMD:

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

and specifically to Section 8, "Differences between the Australian and European Union medical device regulatory requirements" (it's only 13 pages, and a lot would be N/A to you ).

You can also have a look at the official classification regulations:

http://www.austlii.edu.au/au/legis/c...2400/sch2.html

Or, if you're still lost, send me the labeling (contact me via PM) and I'll sort it out for you.

Cheers from Down Under,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #3  
Old 14th June 2012, 08:42 AM
cmeby

 
 
Total Posts: 26
Re: Image Viewer Classification in Australia (Software Image Processing similar to PA

Thank you Ronen
The third document you referenced is the one that I used as well. I am quite confident that our device is Class I with a measuring function.
I sincerely appreciate your help.
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