Commonwealth legislation

Therapeutic Goods (Articles that are Medical Devices) Specification 2014

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

2/10 complexity

This law treats certain genetic susceptibility test kits and pregnancy tests (including their required software) as "medical devices" under Australia’s Therapeutic Goods Act. It applies when manufacturers or suppliers intend those products to predict future disease risk or detect pregnancy, provided they do not act primarily by drugs, immune responses, or metabolism.

That means affected products must meet Australian safety, quality, and performance rules before supply, protecting consumers from unreliable results.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Articles that are Medical Devices) Specification 2014.

Therapeutic Goods (Articles that are Medical Devices) Specification 2014

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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

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

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Therapeutic Goods (Articles that are Medical Devices) Specification 2014

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

(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

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