Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41bd
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41BD
Character Range: 23347–25428

41BD  What is a medical device

 (1) A medical device is:
 (a) any instrument, apparatus, appliance, 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, treatment or alleviation of disease;
 (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
 (iii) investigation, replacement or modification of the anatomy or of a physiological process;
 (iv) control of conception;
  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
 (b) an accessory to such an instrument, apparatus, appliance, material or other article.

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 article is to be used is to be ascertained from the information supplied, by the person under whose name the article is or is to be supplied, on or in any one or more of the following:
 (a) the labelling on the article;
 (b) the instructions for using the article;
 (c) any advertising material relating to the article.

 (3) The Secretary may, by order published in the Gazette, declare that a particular instrument, apparatus, appliance, material or other article, or that a particular class of instruments, apparatus, appliances, 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.

 (4) A declaration under this section takes effect on the day on which the declaration is published in the Gazette or on such later day as is specified in the order.