cmeby

Involved In Discussions
#1
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!!:thanx:
 

Ronen E

Just a person
Super Moderator
#2
Re: Image Viewer Classification in Australia (Software Image Processing similar to PA

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!!:thanx:
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/cth/consol_reg/tgdr2002400/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.
 

cmeby

Involved In Discussions
#3
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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