Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p10
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 10/19)
Character Range: 242349–245060

of that Schedule.

11.57  Class 4 in‑house IVD medical devices
  Item 2.10A of the table in Part 2 of Schedule 4, as inserted by Schedule 7 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to the following:
 (a) a Class 4 in‑house IVD medical device that is manufactured on or after the commencement of this regulation;
 (b) a Class 4 in‑house IVD medical device that is manufactured before that commencement and is intended by its manufacturer to be used on or after that commencement.

Division 11.12—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021

11.58  Application provisions

Conformity assessment
 (6) The amendments made by Part 3 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021 apply in relation to an application for a kind of medical device to be included in the Register that is made on or after the commencement of that Part.

Division 11.13—Application, saving and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021

11.59  System or procedure packs

Applications and entries other than a transitional kind of medical device
 (1) The amendments made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply 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 25 November 2021;
 (b) a kind of medical device that is included in the Register as a result of such an application.

Transitional kind of medical device
 (2) The amendments made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to a transitional kind of medical device on and after 25 November 2025.

Exempt devices
 (3) The amendments made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, to the extent the amendments relate to a system or procedure pack covered by an item in Part 1 of Schedule 4, or by column 2 of an item in Part 2 of Schedule 4, to these Regulations, apply in relation to a system or procedure pack that is manufactured on or after 25 November 2025.

Definitions
 (4) In this regulation:
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 kind of medical device means a kind of medical device included in the Register because of an application that was made before