Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
9Classes of medical device for which accompanying information is not determined
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9 Classes of medical device for which accompanying information is not determined
To avoid doubt, no kind of information is determined for the purposes of subsection 41FDB(7) for an application in relation to a medical device in one of the following classifications:
(a) an in-house IVD medical device other than a Class 4 in-house IVD medical device;
(b) a medical device used for a special purpose that is not a system or procedure pack.
Note: In effect, this means that no information must accompany applications in relation to these classifications.