Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p10
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 10/11)
Character Range: 334102–336806

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 Class IIa.

5.5  Medical devices containing non‑viable animal tissues, cells or their derivatives
 (1) Subject to subclause (2), this clause applies to a medical device if the device contains any of the following:
 (a) non‑viable tissues, or cells, of animal origin (other than tissues or cells from hair or wool);
 (b) derivatives of tissues or cells covered by paragraph (a) (other than sintered hydroxyapatite or tallow derivatives).
 (2) This clause does not apply to a medical device if the device is intended by the manufacturer to come into contact with intact skin only.
 (3) A device to which this clause applies is classified as Class III.

5.6  Medical devices that are blood bags
  A medical device that is a blood bag is classified as Class IIb.

5.7  Active implantable medical devices
 (1) An active implantable medical device is classified as Class III.
 (2) An implantable accessory to an active implantable medical device is classified as Class III.
 (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 implantable medical device is classified as Class III.

5.8  Medical devices intended for export only
  Despite any other classification in this Schedule, a medical device that is intended by the manufacturer to be for export only is classified as Class I.

5.9  Medical devices that are mammary implants
  A medical device that is a mammary implant is classified as Class III.

5.10  Medical devices that administer medicines or biologicals by inhalation
  If a medical device is intended to be used to administer medicines or biologicals by inhalation:
 (a) if the mode of action of the device has an essential impact on the efficacy and safety of the medicines or biologicals—the device is classified as Class IIb; or
 (b) if the device is intended to treat a life‑threatening condition—the device is classified as Class IIb; or
 (c) if paragraphs (a) and (b) do not apply—the device is classified as Class IIa.

5.11  Medical devices that are substances to be introduced into the body or applied to and absorbed by the skin
  If a medical device is composed of substances, or combinations of substances, that are intended to be:
 (a) introduced into the human body through a body orifice; or
 (b) applied to and absorbed by the skin;
the device is classified as follows:
 (c) if the device is introduced into the nasal or oral cavity as far as