Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p9
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 9/19)
Character Range: 239828–242586

(4) or (5); and
 (b) do not affect whether such a device is of the same kind as another device.
 (3) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was either a Class 4 in‑house IVD medical device or an IVD medical device other than an in‑house IVD medical device, and:
 (a) was included in the Register; or
 (b) was the subject of an application for inclusion in the Register that had not been finally determined.
 (4) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was either a Class 4 in‑house IVD medical device or an IVD medical device other than an in‑house IVD medical device, that:
 (a) was not included in the Register but was covered by a conformity assessment certificate having effect; or
 (b) was proposed to be covered by a conformity assessment certificate for which an application had been made but not finally determined.
 (5) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was:
 (a) a Class 1 in‑house IVD medical device; or
 (b) a Class 2 in‑house IVD medical device; or
 (c) a Class 3 in‑house IVD medical device.
 (6) Subregulation (2) does not prevent the making and determination on or after 1 February 2020 and before 26 May 2026 of an application for inclusion in the Register of a device covered by subregulation (3), (4) or (5) in accordance with these Regulations as amended by Schedule 4 to the amending regulations.
 (7) Paragraph (h) of item 1.5 of the table in Part 1 of Schedule 5 does not apply to an application described in subregulation (6) of this regulation (made within the period described in that subregulation).
Note: This means that an application described in subregulation (6) can pass the preliminary assessment without payment of any fee.

Division 11.11—Application provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020

11.55  System or procedure packs
  The amendments made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to a system or procedure pack that is manufactured on or after the commencement of that Part.

11.56  Period for notifying adverse events
  Paragraph 5.7(1)(d), as inserted by Schedule 3 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to information that a person becomes aware of on or after the commencement 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