Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 3/11)
Character Range: 317363–319990

medical device that is classified as Class IIa or higher, the device is classified as Class IIa.

3.2  Surgically invasive medical devices intended for transient use
 (1) This clause applies to a surgically invasive medical device that is intended for transient use.
 (2) Subject to subclauses (3) to (5), the device is classified as Class IIa.
 (3) If the device is intended by the manufacturer specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body, the device is classified as Class III.
 (3A) If the device is not a reusable surgical instrument and the device is intended by the manufacturer specifically to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient, the device is classified as Class III.
 (4) If the device is a reusable surgical instrument, the device is classified as Class I.
 (5) If:
 (a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or
 (b) the device is intended by the manufacturer to have a biological effect; or
 (c) the device is intended by the manufacturer to be wholly, or mostly, absorbed by the patient's body; or
 (d) the device is intended by the manufacturer to be used to administer medicine to a patient by means of a delivery system, and the administration is potentially hazardous to the patient having regard to the characteristics of the device;
the device is classified as Class IIb.

3.3  Surgically invasive medical devices intended for short‑term use
 (1) This clause applies to a surgically invasive medical device that is intended for short‑term use.
 (2) Subject to subclauses (3) and (4), the device is classified as Class IIa.
 (3) If:
 (a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or
 (b) the device is intended by the manufacturer to undergo a chemical change in a patient's body (other than a device that is intended by the manufacturer to be placed in the teeth); or
 (c) the device is intended by the manufacturer to administer medicine;
the device is classified as Class IIb.
Note for paragraph (b): A device that is intended by the manufacturer to be placed in the teeth, and to undergo a chemical change in the body, is classified as Class IIa—see subclause (2).
 (4) If the device is intended by the manufacturer:
 (a) specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a