Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41BD

  (1)   A medical device is:

  (a)   any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

  (i)   diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;

  (ii)   diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

  (iii)   investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;

  (iv)   control or support of conception;

  (v)   in vitro examination of a specimen derived from the human body for a specific medical purpose;

    and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

  (aa)   any instrument, apparatus, appliance, software, implant, reagent, material or other article specified under subsection   (2A); or

  (ab)   any instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection   (2B); or

  (b)   an accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph   (a), (aa) or (ab); or

  (c)   a system or procedure pack.

Note:   Declarations under subsection   (3) exclude articles from the scope of this definition. Declarations under section   7 can also have this effect: see subsection   7(4).

  (2)   For the purposes of paragraph   (1)(a), the purpose for which an instrument, apparatus, appliance, software, implant, reagent, material or other article (the main equipment ) is to be used is to be ascertained from the information supplied, by the person under whose name the main equipment is or is to be supplied, on or in any one or more of the following:

  (a)   the labelling on the main equipment;

  (b)   the instructions for using the main equipment;

  (c)   any advertising material relating to the main equipment;

  (d)   technical documentation describing the mechanism of action of the main equipment.

  (2A)   The Secretary may, by notice published in the Gazette or on the Department's website, specify a particular instrument, apparatus, appliance, software, implant, reagent, material or other article for the purposes of paragraph   (1)(aa). The notice is not a legislative instrument. The notice takes effect on the day on which the notice is published in the Gazette or on the Department's website or on such later day as is specified in the notice.

  (2B)   The Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles for the purposes of paragraph   (1)(ab).

  (3)   The Secretary may, by legislative instrument , declare that a particular instrument, apparatus, appliance, software, implant, reagent, material or other article, or that a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles, are not, for the purposes of this Act, medical devices.

Note:   A declaration under this section does not stop articles from being therapeutic goods.