Federal Register of Legislation - Australian Government

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Specifications as made
This instrument specifies that instruments, apparatus, appliances, materials or other articles that are used for the purpose of predicting the susceptibility or predisposition of persons to a disease or ailment, or for testing pregnancy in persons, are medical devices for the purposes of the Therapeutic Goods Act 1989.
Administered by: Health
Registered 17 Dec 2014
Tabling HistoryDate
Tabled HR09-Feb-2015
Tabled Senate09-Feb-2015
Date of repeal 24 Apr 2020
Repealed by Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020

Therapeutic Goods (Articles that are Medical Devices) Specification 2014

Therapeutic Goods Act 1989

I, JOHN SKERRITT, delegate of the Secretary of the Department of Health, make this Specification under subsection 41BD(2B) of the Therapeutic Goods Act 1989.

Dated December 15, 2014

(Signed by)

 

JOHN SKERRITT

Delegate of the Secretary of the Department of Health


1              Name of Specification

                This Specification is the Therapeutic Goods (Articles that are Medical Devices) Specification 2014.

2              Commencement

                This Specification commences on the day after it is registered.

3              Articles that are medical devices

                For the purposes of paragraph 41BD(1)(ab) of the Therapeutic Goods Act 1989, the following classes of instruments, apparatus, appliances, materials or other articles are specified˗˗ instruments, apparatus, appliances, materials or other articles (whether used alone or in combination, and including the software necessary for their proper application) that:

(a)    are intended by the person under whose name they are or are to be supplied to be used for the examination of a specimen derived from a human  body for the purpose of:

(i)                 predicting the susceptibility or predisposition of persons to a disease or ailment; or

(ii)               testing for pregnancy in persons; and

(b)   do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in their function by such means.

 

 

Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au