Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41fh
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41FH
Character Range: 715262–716629

41FH  Selecting applications for auditing
 (1A) This section applies to applications that have passed preliminary assessment.
 (1) The Secretary:
 (a) must select for auditing any application for a kind of medical device to be included in the Register that is an application of the kind prescribed by the regulations; and
 (b) may select for auditing any other application for a kind of medical device to be included in the Register.
Note: An application audit assessment fee is payable in respect of any application that the Secretary must select for auditing: see Part 4‑10.
 (2) If an application is selected for auditing:
 (a) the Secretary must give the applicant a written notice (the selection notice) that:
 (i) informs the applicant of the selection; and
 (ii) requires the applicant to provide, within the period specified in the notice, information or documents that the Secretary is satisfied is relevant to the audit; and
 (b) the application must be dealt with under this Subdivision and not under Subdivision B.
 (3) The selection notice must be given within:
 (a) 20 working days after the application is made and the prescribed application fee is paid; or
 (b) if the regulations prescribe a longer period for that kind of application—that longer period.
 (4) Subparagraph (2)(a)(ii) does not limit section 41JA (Secretary may require information).