Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p5
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 5/11)
Character Range: 322098–324739

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.

Part 4—Special rules for active medical devices

4.1  Active medical devices—general
  An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this Part or in Part 2, 3 or 5.

4.2  Active medical devices for therapy
 (1) Subject to subclause (2), an active medical device for therapy that is intended by the manufacturer to be used to administer energy to a patient, or exchange energy to or from a patient, is classified as Class IIa.
 (2) If the device is of a kind such that the administration or exchange of energy occurs in a potentially hazardous way, having regard to the nature, density and site of application of the energy, the device is classified as Class IIb.
 (3) An active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active medical device for therapy of the kind mentioned in subclause (2) is classified as Class IIb.
 (4) An active medical device for therapy that includes a diagnostic function the purpose of which is to significantly determine patient management by the device is classified as Class III.
Example: An automated external defibrillator.

4.3  Active medical devices for diagnosis
 (1) This clause applies to an active medical device for diagnosis.
 (2) If:
 (a) the device is intended by the manufacturer to be used to supply energy that will be absorbed by a patient's body (other than a device that is intended only to illuminate the patient's body in the visible spectrum); or
 (b) the device is intended by the manufacturer to be used to image in vivo distribution of radiopharmaceuticals in a patient; or
 (c) the device is intended by the manufacturer to be used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than a device of a kind mentioned in paragraph (3)(a));
the device is classified as Class IIa.
Note for paragraph (a): A device that is intended only to illuminate the patient's body in the visible spectrum is classified as Class I—see clause 4.1 of this Schedule.
 (3) If:
 (a) the device is intended by the manufacturer specifically to be used to monitor vital physiological parameters of a patient, and the nature of the variations monitored is