Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020
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4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) medical device; and
(b) State.
In this instrument:
Act means the Therapeutic Goods Act 1989.
Class 1 IVD medical device has the same meaning as in the Regulations.
Class 2 IVD medical device has the same meaning as in the Regulations.
Class 3 IVD medical device has the same meaning as in the Regulations.
Class 4 IVD medical device has the same meaning as in the Regulations.
government health screening program means a health screening program that is conducted, approved or funded by the Commonwealth or a State.
Note: State is defined in subsection 3(1) of the Act as including the Australian Capital Territory and the Northern Territory.
IVD medical device for self-testing has the same meaning as in the Regulations.
Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
SARS-CoV-2, or severe acute respiratory syndrome coronavirus 2, means the virus that causes coronavirus disease (COVID-19).
Note: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the name given by the International Committee on Taxonomy of Viruses to the virus that causes coronavirus disease (COVID-19).
serious disease has the same meaning as in the Regulations.