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

sreenu927

Quite Involved in Discussions
#1
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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kbryde

#2
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
 

sreenu927

Quite Involved in Discussions
#3
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
 

medwise

Involved In Discussions
#5
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
 

Ronen E

Problem Solver
Staff member
Moderator
#6
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.
 

sreenu927

Quite Involved in Discussions
#7
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
 

medwise

Involved In Discussions
#8
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
 

Ronen E

Problem Solver
Staff member
Moderator
#9
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
Hi,

Has this been stated to you by the TGA or have you seen it in a written guidance? IMO the statement above might be a little far-reaching. Sometimes 2 significantly different intended uses might fall under the same GMDN code and at the same time these would be considered two different kinds of devices (even when the manufacturer and sponsor are the same).

Cheers,
Ronen.
 
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