Document ID: chunk:federal_register_of_legislation:C2025C00097:section:5:p2
Version: federal_register_of_legislation:C2025C00097
Segment Type: section
Provision Reference: s 5 (pt 2/56)
Character Range: 86823–89632

have the Private Health Insurance (Medical Devices and Human Tissue Products) Rules list a *medical device or *human tissue product of the kind to which the application relates.
 (3) The application must be:
 (a) in the *approved form; and
 (b) accompanied by any *cost‑recovery fee that the applicant is liable to pay at the time the application is made.
 (4) The Minister must inform the applicant in writing of the Minister's decision whether or not to grant the application. If the Minister decides not to grant the application, the Minister must also inform the applicant of the reason for that decision.
 (5) If:
 (a) the Minister grants the application; and
 (b) the applicant pays to the Commonwealth any *cost‑recovery fee that the applicant is liable to pay in connection with the initial listing of the kind of *medical device or *human tissue product to which the application relates;
the Minister must, on the next occasion when the Minister makes or varies the Private Health Insurance (Medical Devices and Human Tissue Products) Rules:
 (c) list the kind of *medical device or *human tissue product to which the application relates in those Rules; and
 (d) set out in those Rules a minimum benefit for the medical device or human tissue product; and
 (e) if the Minister considers it appropriate—set out in those Rules a maximum benefit for the medical device or human tissue product.
Note: Despite this subsection, the Minister may, under section 72‑25, refuse to perform a function under this subsection if the applicant fails to pay a cost‑recovery fee or medical devices and human tissue products levy that is due and payable.
 (6) The Private Health Insurance (Medical Devices and Human Tissue Products) Rules may set out criteria (listing criteria) to be satisfied in order for an application (a listing application) made under subsection (2) to be granted. The Rules may provide for different listing criteria to apply in different circumstances.
 (7) The Minister must not grant a listing application if any applicable listing criteria are not satisfied in relation to the application.
Note: The Minister may refuse to grant a listing application even if the applicable listing criteria are satisfied.

72‑11  Meaning of medical device
 (1) A medical device is:
 (a) any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
 (i) prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
 (ii) monitoring, treatment, alleviation of or compensation for an injury or disability;