Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p8
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 8/19)
Character Range: 237387–240054

with subregulation (5) if:
 (a) a kind of medical device is included in the Register in relation to the person; and
 (b) the kind of medical device so included is a transitional kind of medical device; and
 (c) medical devices of that kind are medical devices that are covered by subregulation (2), (3) or (4).
 (2) This subregulation covers a medical device that is intended by the manufacturer to be used to record patient images that are to be used for either or both of the following:
 (a) the diagnosis or monitoring of a disease, injury or disability;
 (b) the investigation of the anatomy or of a physiological process;
where the images are to be acquired through a method that relies on energy outside the visible spectrum.
 (3) This subregulation covers a medical device that is an anatomical model (whether physical or virtual) that is intended by the manufacturer to be used for either or both of the following:
 (a) the diagnosis or monitoring of a disease, injury or disability;
 (b) the investigation of the anatomy or of a physiological process.
 (4) This subregulation covers a programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to generate a virtual anatomical model that is to be used for either or both of the following:
 (a) the diagnosis or monitoring of a disease, injury or disability;
 (b) the investigation of the anatomy or of a physiological process.
 (5) The notice must:
 (a) be in writing; and
 (b) state:
 (i) the unique device number assigned to that kind of device under section 41FL of the Act; and
 (ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and
 (c) be given to the Secretary before the later of:
 (i) 25 August 2021; and
 (ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device.

Subdivision E—IVD companion diagnostics

11.54  IVD companion diagnostics

Applications required to be audited
 (1) The amendment of paragraph 5.3(1)(j) by Schedule 4 to the amending regulations applies to applications made on or after 1 February 2020.

Classification and kind of medical device
 (2) Despite the amendments made by Schedule 4 to the amending regulations on 1 February 2020, until 26 May 2026 those amendments:
 (a) do not affect the classification of a device covered by subregulation (3), (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