The definition of a medical device according to Section 41BD of the Australian Therapeutic Goods Act 1989 is given below:
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;
iiii. 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.
The definition of an IVD according to the Therapeutic Goods (Medical Device) Regulation 2002 as amended is given below:
a. a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with another diagnostic product for in vitro use; and
b. intended by the manufacturer to be used in vitro for the examination of a specimen derived from the human body, solely or principally for:
(i) giving information about a physiological or pathological state or a congenital abnormality; or
(ii) determining safety and compatibility with a potential recipient; or
(iii) monitoring therapeutic measures; and
c. not a product that is:
(i) intended for general laboratory use; and
(ii) not manufactured, sold or presented for use as an IVD medical device.