Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p11
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 11/26)
Character Range: 672583–675464

regulation has the meaning given by subclause 2(2) of Schedule 3AA.
faecal microbiota transplant product means a thing that:
 (a) comprises, contains or is derived from human stool; and
 (b) is for introduction into a person for a therapeutic use.
full designation conformity assessment body determination means a conformity assessment body determination that is of general application.
full quality assurance procedures means the conformity assessment procedures set out in Part 1 of Schedule 3.
health professional includes a person who is:
 (a) a medical practitioner, or a dentist or any other kind of health care worker registered under a law of a State or Territory; or
 (b) a biomedical engineer, chiropractor, optometrist, orthodontist, osteopath, pharmacist, physiotherapist, podiatrist, prosthetist or rehabilitation engineer.
hip joint means the ball and socket formed by the reception of the head of the femur into the cup‑shaped cavity of the acetabulum.
immunohaematology reagent IVD medical device means an IVD medical device that is a reagent, reagent product or related material that is intended by the manufacturer to be used to provide information about blood groups, red cell antigens or red cell antibodies, or to determine compatibility of blood or blood components for transfusion.
implantable breast medical device means any of the following implantable medical devices:
 (a) breast implants or mammary implants;
 (b) breast tissue expanders;
 (c) any other medical device that is of a similar kind, or has a similar function, to a medical device mentioned in paragraph (a) or (b).
implantable cardiac medical device means any of the following implantable medical devices or active implantable medical devices:
 (a) cardiac stents;
 (b) cardiac valves (whether mechanical or of biological origin);
 (c) electronic devices for regulating heart rate or managing dysrhythmia;
 (d) any other medical device that is of a similar kind, or has a similar function, to a medical device mentioned in paragraph (a), (b) or (c).
implantable medical device means a medical device (other than an active implantable medical device) that is intended by the manufacturer:
 (a) to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure; or
 (b) to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure; or
 (c) to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure.
in‑house IVD medical device means an IVD medical device that is:
 (a) within the confines or scope of an Australian laboratory or Australian laboratory network:
 (i) developed from first principles; or
 (ii) developed or modified from a published source;