Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p4
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 4/11)
Character Range: 319754–322319

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 patient through direct contact with these parts of the body; or
 (b) specifically to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient; or
 (c) to have a biological effect; or
 (d) to be wholly, or mostly, absorbed by a patient's body;
the device is classified as Class III.
 (5) For this clause, a medical device that is intended by the manufacturer to be placed in the teeth includes a medical device that is intended by the manufacturer to penetrate a tooth, but does not include a medical device that is intended by the manufacturer to penetrate a tooth and enter the gum or bone beyond the tooth.

3.4  Surgically invasive medical devices intended for long‑term use and implantable medical devices
 (1) This clause applies to:
 (a) a surgically invasive medical device that is intended for long‑term use; and
 (b) an implantable medical device.
 (2) Subject to subclauses (3), (4), (4A) and (4B), the device is classified as Class IIb.
 (3) If the device is intended by the manufacturer to be placed in the teeth of a patient, the device is classified as Class IIa.
 (4) If the device is intended by the manufacturer:
 (a) to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient; or
 (b) to have a biological effect; or
 (c) to be wholly, or mostly, absorbed by a patient's body; or
 (d) 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
 (e) to be used to administer medicine;
the device is classified as Class III.
Note for paragraph (d): 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 (3).
 (4A) The device is classified as Class III if it is:
 (a) a joint replacement medical device; or
 (b) surgical mesh.
 (4B) If the device is intended by the manufacturer to be a motion‑preserving device for the spine (such as a spinal disc replacement), the device is classified as Class III.
 (5) For this clause, a medical device that is intended by the manufacturer to be placed in the teeth includes a medical device that is intended by the manufacturer to penetrate a tooth, but does not include