Document ID: chunk:federal_register_of_legislation:F2025L00198:reg:23
Version: federal_register_of_legislation:F2025L00198
Segment Type: reg
Provision Reference: reg 23
Character Range: 35991–38228

23  Waiver of cost‑recovery fees
 (1) For the purposes of paragraph 72‑15(2)(e) of the Act, this section specifies the circumstances in which the Minister may waive a cost‑recovery fee.

Related medical devices
 (2) The Minister may waive a clinical assessment fee or economic assessment fee (the relevant fee) payable by a person in relation to a listing application or variation application (the relevant application) that relates to a medical device if:
 (a) the person has also made one or more other listing applications or variation applications (the other applications) that relate to medical devices; and
 (b) each of the medical devices to which the relevant application and the other applications relate are related medical devices; and
 (c) in the case of a clinical assessment fee—the Minister is satisfied that:
 (i) the related medical devices can be considered as part of a single clinical assessment or as part of one or more abridged clinical assessments; and
 (ii) a clinical assessment fee in relation to at least one of the other applications has not been waived under this subsection; and
 (d) in the case of an economic assessment fee—the Minister is satisfied that:
 (i) the related medical devices can be considered as part of a single economic assessment or as part of one or more abridged economic assessments; and
 (ii) an economic assessment fee in relation to at least one of the other applications has not been waived under this subsection; and
 (e) the person makes a request, at the same time the relevant application is made, for waiver of the relevant fee; and
 (f) the waiver request includes reasons why paragraph (c) or (d) (as the case may be) is expected to apply in relation to the relevant application.
Note 1: The relevant application, and the other applications, referred to in subsection (2) may not be the only listing applications and variation applications that have been made by the person.
Note 2: For when medical devices are related, see section 4.
Note 3: Notice must be given of a decision to refuse to agree to a request under this subsection for a waiver (see subsection 25(1)). Such a decision made by a delegate of the Minister is reviewable (see section 26).

Division 4—Review