Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p16
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 16/19)
Character Range: 257189–259933

of Schedule 2 to these Regulations made by Part 3 of Schedule 2 to the amending regulations applies in relation to the following:
 (a) an application for a kind of medical device to be included in the Register that is made on or after 1 July 2024;
 (b) a kind of medical device that is included in the Register as a result of such an application.

Applications and entries for transitional medical devices
 (2) Subject to subregulations (3) and (4) of this regulation, the amendment of clause 5.5 of Schedule 2 to these Regulations made by Part 3 of Schedule 2 to the amending regulations applies in relation to a transitional medical device on and after 1 July 2026.
 (3) The amendment of clause 5.5 of Schedule 2 to these Regulations made by Part 3 of Schedule 2 to the amending regulations does not apply in relation to a transitional medical device before the day applicable under subregulation (4) of this regulation, if:
 (a) a person applies under the Act:
 (i) on or after the inclusion day for the entry of the transitional medical device; and
 (ii) on or after 1 July 2024; and
 (iii) before 1 July 2026;
  to have a kind (the new kind) of medical device included in the Register; and
 (b) the new kind of device would, but for the amendment, be the same kind of medical device as the transitional medical device.
 (4) For the purposes of subregulation (3), the day is the day after the day on which the application mentioned in paragraph (3)(a):
 (a) is withdrawn; or
 (b) lapses under section 41FK of the Act; or
 (c) is finally determined.
 (5) Subregulation 5.3(1) does not apply to an application for inclusion of the new kind of device in the Register.

Division 11.21—Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024

11.78  Application provision—application audit assessment fees
  Table items 1.14A, 1.14AA and 1.14B of Part 1 of Schedule 5 to these Regulations, as amended or inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024, apply in relation to an application that is made on or after 1 July 2024 and in relation to which an application audit assessment fee is payable because of subsection 41LA(3) of the Act.

Division 11.22—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024

11.79  Definitions
  In this Division:
amending regulations means the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024.

11.80  Application of amendments
 (1) The amendment made by item 3 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the