Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p8
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 8/30)
Character Range: 156218–158779

or verification procedures).
 (2) The Secretary may reduce the amount of the assessment fee if the Secretary has information that allows the assessment to be abridged, being information about:
 (a) the medical device to which the fee relates; or
 (b) some or all aspects of whether the conformity assessment procedures have been applied to the medical device.

9.8  Refund of fees—kinds of medical devices covered by former regulation 4.1
 (1) If:
 (a) on or after 1 January 2019 and before the commencement of this regulation, a person made an application under section 41EB of the Act for a conformity assessment certificate in respect of a kind of medical device covered by regulation 4.1 (as in force immediately before 28 July 2021); and
 (b) on or after 1 January 2019 and before 1 December 2021, the person paid all or part of one or more of the following:
 (i) the fee covered by item 1.1 of the table in Part 1 of Schedule 5 in connection with the application;
 (ii) the fee covered by item 1.9, 1.9A, 1.10 or 1.10A of the table in Part 1 of Schedule 5 (to the extent that fee is in connection with the application);
 (iii) the fee covered by item 1.11 or 1.12 of the table in Part 1 of Schedule 5 (to the extent that fee is in connection with the application);
 (iv) the fee covered by clause 2.1 or 2.2 in Part 2 of Schedule 5 (to the extent that fee is in connection with the application); and
 (c) on or after 28 July 2021 and before 1 March 2022, the person, by notice in writing given to the Secretary, withdrew the application; and
 (d) the person withdrew the application before the Secretary had made a decision on the application; and
 (e) on or after 28 July 2021 and before 1 March 2022, the person requested the Secretary, in writing, for a refund of that fee; and
 (f) the request is accompanied by information that satisfies the requirements of subparagraphs 41FDB(2)(d)(i) and (ii) of the Act for that classification of medical device;
then, before the end of the applicable period, the Secretary must:
 (g) decide whether or not to refund any of that fee; and
 (h) if the Secretary decides to make a refund on behalf of the Commonwealth—decide the amount of that fee to be refunded.
 (2) In making a decision under paragraph (1)(g) or (h), the Secretary must take into account the extent of completion of the assessment or assessments, or of the testing, in connection with the application for the conformity assessment certificate, at the time the person withdrew the application.
 (3) Subregulation (2) does not limit the matters the