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Is TGA approval required for a ARTG listed IVD for a sample type addition?
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Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
Is TGA approval required for a ARTG listed IVD for a sample type addition?
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Is TGA approval required for a ARTG listed IVD for a sample type addition?


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Some Related Topic Tags
artg (australian register of therapeutic goods), ivd (in vitro diagnostic) devices and reagens, sted (summary technical documents), tga (therapeutic goods administration)
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  Post Number #1  
Old 19th August 2014, 11:45 PM
sreenu927

 
 
Total Posts: 541
Question Is TGA approval required for a ARTG listed IVD for a sample type addition?

Hi All,

For a Class 2 and 3 IVDs with Australia's TGA approval, if we include additional sample or specimen type, will it require any updated STED file submission to TGA and seek approval before selling it or just a change notification will do?

Thanks,
Sreenu

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  Post Number #2  
Old 20th August 2014, 05:39 AM
kbryde

 
 
Total Posts: 7
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Hi there,

For our Class 2 IVDs, our sponsor has informed us that when we add new products with same GMDN code and description, we only have to submit an updated DoC along with a reference to the ARTGC it affects. We have never updated our submission with additional documents.

Best Regards

kbryde
  Post Number #3  
Old 20th August 2014, 05:45 AM
sreenu927

 
 
Total Posts: 541
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Hi Kbryde,

Thanks for sharing your experience. But here in this case, the intended use statement is changing; however, the description in the ARTG is general. Usually, if intended use is changed, then it requires either a change notification or a new registration.

Regards,
Sreenu
  Post Number #4  
Old 21st August 2014, 10:36 PM
sreenu927

 
 
Total Posts: 541
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Any help??

Thanks,
Sreenu
  Post Number #5  
Old 16th October 2014, 08:14 PM
medwise

 
 
Total Posts: 102
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Hi Sreenu,

ARTG entry is for a "kind of medical device" i.e. -
  • Same manufacturer
  • Same Sponsor
  • Same GMDN and
  • Same Classification
If all the above are same new registration is not required.

Hope this helps.
Romit
  Post Number #6  
Old 17th October 2014, 01:35 AM
Ronen E

 
 
Total Posts: 3,736
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Quote:
In Reply to Parent Post by romit singh View Post

Hi Sreenu,


ARTG entry is for a "kind of medical device" i.e. -
  • Same manufacturer
  • Same Sponsor
  • Same GMDN and
  • Same Classification
If all the above are same new registration is not required.

Hope this helps.
Romit
That's quite a liberal interpretation. I would verify with the TGA on an individual case basis. Intended use should also be taken into consideration.

Cheers,
Ronen.
  Post Number #7  
Old 17th October 2014, 02:25 AM
sreenu927

 
 
Total Posts: 541
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Hi Romit and Ronen,

I have checked with TGA on this. They responded that if there is no impact to the ARTG (register), then no notification is required. If a new model or identified is to be included that requires a change to ARTG, then a notification to TGA is required.
But for intended use change, as Ronen mentioned, it is not clear. However, most of the cases, if impact to intended use change, it will require re-registration.

Thanks,
Sreenu
  Post Number #8  
Old 18th October 2014, 08:57 PM
medwise

 
 
Total Posts: 102
Re: Is TGA approval required for a ARTG listed IVD for a sample type addition?

Hi Sreenu,

Impact to intended use can be determined by GMDN. If the intended use update necessitates consideration of new GMDN term then a new application will be required. Alternatively, if the scope of the intended use has changed but can still be covered by the same GMDN term then a change application can be made.

Kind regards
Romit
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