Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p8
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 8/26)
Character Range: 664658–667625

any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.
Software that is a medical device is an active medical device.
active medical device for diagnosis means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to supply information for the purpose of detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.
active medical device for therapy means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to support, modify, replace or restore biological functions or structures for the purpose of treating or alleviating an illness, injury or handicap.
adaptable medical device means a mass‑produced medical device that is intended by the manufacturer to be assembled or adapted after it has been supplied, in accordance with the manufacturer's instructions, to:
 (a) address either or both of the anatomical and physiological features of a particular individual; or
 (b) address a pathological condition of a particular individual; or
 (c) otherwise perform as intended by the manufacturer.
AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.
ancillary medical device means an implantable medical device that:
 (a) consists of screws, plates or wedges; or
 (b) is intended by the manufacturer to be used to:
 (i) provide stability for an implantable medical device that is intended to (either alone or together with one or more other implantable medical devices) replace the shoulder joint, hip joint or knee joint; or
 (ii) provide bone substitution in relation to, or additional fixation for, any such device; or
 (iii) otherwise assist any such device;
  where the individual requirements of a patient make it appropriate to do so.
animal means an invertebrate or vertebrate member of the animal kingdom.
approved indications, of a medicine, biological or other therapeutic goods, means:
 (a) if the medicine, biological or other therapeutic goods are entered on the Register—the indications included in the Register in relation to the medicine, biological or other therapeutic goods; or
 (b) otherwise—the indications in relation to the medicine, biological or other therapeutic goods.
Note: For indications, see subsection 3(1) of the Act.
approved type means a type that has been examined and approved by the Secretary under the type examination procedures.
Australian legal unit of measurement has the meaning given by the National Measurement Act 1960.
authorised person—see regulation 10.1.
body orifice:
 (a) means a natural opening, or a permanent artificial