Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
8Alternative kinds of information
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8 Alternative kinds of information
Medical devices other than IVD medical devices (1) An application for a medical device other than an IVD medical device may be accompanied by the kind of information determined under section 5 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned, rather than the kind of information determined for that class of medical device under that section. IVD medical devices (2) An application for an IVD medical device may be accompanied by the kind of information determined under section 6 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned, rather than the kind of information determined for that class of medical device under that section.
Note: The kind of information determined under sections 5 and 6 relate to the minimum conformity assessment procedures that the manufacturer must apply to a kind of device of that classification.