Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p9
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 9/11)
Character Range: 331653–334337

separately, would be a medicine; and
 (b) is liable to act on a patient's body with action ancillary to that of the device.
 (2) The device is classified as Class III.
 (3) For the purposes of this clause, any stable derivative of human blood or human plasma is considered to be a medicine.

5.2  Medical devices intended for contraception or prevention of sexually transmitted diseases
 (1) Subject to subclause (2), a medical device that is intended by the manufacturer to be used for contraception, or the prevention of sexually transmitted diseases, is classified as Class IIb.
 (2) If the device is an implantable medical device or an invasive medical device that is intended for long‑term use, the device is classified as Class III.

5.3  Medical devices intended for disinfecting, cleaning, etc
 (1) A medical device that is intended by the manufacturer specifically to be used for disinfecting, cleaning, rinsing or hydrating contact lenses is classified as Class IIb.
 (2) A medical device that is intended by the manufacturer specifically to be used for disinfecting another medical device is classified as Class IIb.
 (3) This clause does not apply to a medical device that is intended by the manufacturer to be used only to clean another medical device (other than contact lenses) by means of physical action.
Note: A medical device of the kind described in subclause (3) is classified as Class I—see clause 2.1 of this Schedule.

5.4  Medical devices that record patient images or that are anatomical models etc.
 (1) If:
 (a) a medical device is intended by the manufacturer to be used to record patient images that are to be used for either or both of the following:
 (i) the diagnosis or monitoring of a disease, injury or disability;
 (ii) the investigation of the anatomy or of a physiological process; and
 (b) the images are to be acquired through a method that relies on energy outside the visible spectrum;
the device is classified as Class IIa.
 (2) 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;
is classified as Class IIa.
 (3) 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;
is classified as