Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p15
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 15/19)
Character Range: 254623–257406

that commencement.

Division 11.19—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023

11.73  Application of amendments
  The amendments of these Regulations made by Part 1 of Schedule 2 to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023 (other than the amendments of the Dictionary) apply in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.

Division 11.20—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024

11.74  Definitions
  In this Division:
amending regulations means the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024.
finally determined: an application is finally determined at the first time both the following conditions are met:
 (a) a decision has been made whether or not to grant the application;
 (b) there is no longer any possibility of a change in the outcome of the decision.
inclusion day for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences.
transitional medical device means a medical device of a kind:
 (a) that was, immediately before 1 July 2024:
 (i) included in the Register; and
 (ii) a kind of medical device to which clause 5.5 of Schedule 2 to these Regulations applied; and
 (b) that is, on 1 July 2024, a kind of a medical device to which clause 5.5 of Schedule 2 to these Regulations no longer applies.

11.75  Exemption for certain prescription spectacle lenses
  Item 1.4A of Part 1 of Schedule 4, as inserted by Part 2 of Schedule 1 to the amending regulations, applies in relation to medical devices imported into Australia, exported from Australia, or manufactured or supplied in Australia, on or after the commencement of that item.

11.76  Auditing of applications
 (1) The amendments of regulation 5.3 of these Regulations made by Part 2 of Schedule 2 to the amending regulations apply in relation to applications made on or after 1 July 2024.
 (2) The amendment of regulation 5.12 of these Regulations made by Part 2 of Schedule 2 to the amending regulations applies in relation to a kind of medical device included in the Register on or after 1 July 2024 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day).

11.77  Reclassification of medical devices

Applications and entries other than for transitional medical devices
 (1) 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 the following:
 (a) an application for a kind of medical device to be included in the Register that is