Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p12
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 12/19)
Character Range: 247189–249976

application under regulation 9.1AA if the application had been made on the day on which this regulation commences.

11.62  Medical devices assembled or adapted at point of care
  Item 1.3B of the table in Part 1 of Schedule 4, as inserted by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to a medical device that is manufactured on or after the commencement of that item.

11.63  Patient‑matched medical devices
  Subregulation 7.1(8) and item 1.7 of Part 1 of Schedule 4, as added by Part 6 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, apply in relation to patient‑matched medical devices manufactured on or after the commencement of that item in the following:
 (a) the financial year in which that item commences;
 (b) each later financial year.

11.64  Surgical loan kits
  The amendment made by Part 7 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 applies on and after the commencement of that Part in relation to a surgical loan kit manufactured before, on or after that commencement.

11.66  Surgical mesh
  Regulations 11.29 and 11.30, as in force immediately before the commencement of Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, continue to apply on and after that commencement in relation to an application referred to in paragraph 11.29(3)(a) (as so in force) that was made before that commencement.

Division 11.14—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021

11.67  Patient implant cards and patient information leaflets
  The amendments of clause 13A.1 of Schedule 1 made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to a medical device that is imported, supplied or exported on or after the commencement of that Part.

Division 11.15—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 2) Regulations 2022

11.68  Fee for application for consent of Secretary
 (1) The amendments of Part 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 2) Regulations 2022 apply in relation to an application for consent that is made on or after the commencement of those amendments.
 (2) If:
 (a) on or after 1 January 2022 and before the commencement of this regulation, a person made an application of a kind covered by paragraph (a) or (b) of item 1.15 of the table in Part 1 of Schedule 5; and
 (b) the application was made in relation to the application of one or more of clauses 13.1