Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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).