Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 2/30)
Character Range: 141187–143723

of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time; and
 (e) the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of medical device in the Register during the charge year has been paid.
 (2) The Secretary must, on behalf of the Commonwealth, refund an amount equal to the charge paid if:
 (a) the person who paid the charge applies for the charge to be refunded; and
 (b) the application is made in the form (if any) approved, in writing, by the Secretary for the purposes of this subregulation; and
 (c) the Secretary is reasonably satisfied that subregulation (1) applies in relation to the transitional medical device.

Part 9—Fees

Division 9.1—Fees

9.1  Fees
  The following fees are prescribed:
 (a) the fee mentioned in column 4 of an item in Part 1 of Schedule 5 in relation to the matter mentioned in column 2 of that item;
 (b) the additional fees mentioned in Part 2 of Schedule 5.

Division 9.1A—Reduced fee for consent to import, supply or export implantable medical devices—information requirements

9.1AA  Working out the reduced fee
 (1) If:
 (a) an application is covered by paragraph (a) of item 1.15 of the table in Part 1 of Schedule 5; and
 (b) the application is made solely in relation to:
 (i) the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1 to the medical device; or
 (ii) the application of one or more of clauses 13.1 to 13.4 of Schedule 1 to the medical device, and the reason for the medical device not complying with one or more of those clauses is that the medical device is affected by the EU transition (within the meaning of subregulation (3)); or
 (iii) both subparagraphs (i) and (ii);
the amount of the fee is not worked out in accordance with Part 1 of Schedule 5. Instead, the amount of the fee is $31.
 (2) If:
 (a) an application is covered by paragraph (b) of item 1.15 of the table in Part 1 of Schedule 5; and
 (b) the application is made solely in relation to:
 (i) the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1 to the medical devices; or
 (ii) the application of one or more of clauses 13.1 to 13.4 of Schedule 1 to the medical devices, and the reason for the medical devices not complying with one or more of those clauses is that the medical devices are affected by the EU transition (within the meaning of subregulation (3));