Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p7
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 7/30)
Character Range: 153743–156468

the end of one month after the last day when the amount referred to in paragraph (a) may be paid; and
 (c) the remaining one‑quarter of the fee is due for payment:
 (i) if the relevant application is withdrawn—when the application is withdrawn; and
 (ii) in any other case—when the applicant is notified of the Secretary's decision in respect of the relevant application under section 41EE or 41FJ of the Act.
 (5) If the Secretary receives an application for payment by instalments, the Secretary must:
 (a) within 30 days of receiving the application and any information or material required under subregulation (3), give notice, in writing, to the applicant stating whether the application has been approved; and
 (b) if the application is approved, include with the notice information about the amount of each instalment and when it is due for payment.
 (6) If:
 (a) the Secretary approves an application for payment by instalments; and
 (b) any amount of the instalment payable by the applicant is not paid when it becomes due for payment;
the balance of the fee becomes due for payment.
 (7) This regulation does not apply if another assessment fee, or an evaluation fee under section 24 of the Act, (or part of either of those kinds of fee) that is due for payment by the applicant is unpaid.

9.6  Reduction of assessment fees
  The Secretary may reduce by 70% the amount of an assessment fee specified in Schedule 5 in relation to a medical device if the supply of the medical device:
 (a) is in the interest of public health; and
 (b) would not be commercially viable for the manufacturer or sponsor of the medical device if the full amount of the fee were paid.

9.7  Reduction of assessment fees—abridged assessment
 (1) This regulation applies to an assessment fee specified in Part 1 of Schedule 5 in relation to any of the following:
 (a) items 1.2, 1.3 and 1.3A (review of conformity assessment certificate);
 (b) items 1.9 and 1.9A (initial assessment under conformity assessment procedures);
 (c) item 1.10 (assessment consequent on a change to:
 (i) a medical device; or
 (ii) the quality management system applying to a medical device);
 (ca) item 1.10A (assessment because of changes or proposed changes to:
 (i) an IVD medical device; or
 (ii) the quality management system applying to an IVD medical device);
 (d) items 1.13, 1.14, 1.14A, 1.14AA, 1.14B and 1.14C (application subject to audit assessment);
 (e) item 1.16 (intermediate stage assessment 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)