Therapeutic Goods (Excluded purposes) Specification 2010

as amended

made under section 41BEA of the

Therapeutic Goods Act 1989

Compilation start date:  9 July 2014

Includes amendments up to: Therapeutic Goods (Excluded purposes) Amendment Specification 2014 (No 1)

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Excluded purposes) Specification 2010 as in force on 9 July 2014. It includes any commenced amendment affecting the legislation to that date.

This compilation was prepared on 1 December 2014.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.

Uncommenced amendments

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes.

1 Name of Specification

  This Specification is the Therapeutic Goods (Excluded purposes) Specification 2010.

2 Commencement

  This Specification commences on 1 July 2010.

3 Definitions

  In this Specification:

Act means the Therapeutic Goods Act 1989.

IVD medical device for self-testing has the meaning given by the Dictionary in the Therapeutic Goods (Medical Devices) Regulations 2002.

serious disease has the meaning given by the Dictionary in the Therapeutic Goods (Medical Devices) Regulations 2002.

4 Excluded purposes

 (1) This section applies to a kind of IVD medical device for self-testing.

 (2) For section 41BEA of the Act, each of the following purposes mentioned for a device is specified for paragraph 41FD (ia) and subsection 41FF (1A) of the Act, unless the device is also to be used for another purpose, including a purpose mentioned in subsection (3):

 (a) to test specimens from the human body for the presence of, or exposure to, pathogenic organisms or transmissible agents (other than the Human Immunodeficiency Virus), including agents that cause notifiable infectious diseases;

 (b) genetic testing to determine the presence of, or predict susceptibility to, diseases in humans;

 (c) to diagnose, aid in diagnosis or indicate the presence of a serious disease or condition, such as cancer or myocardial infarction;

 (d) to test for the presence of markers that are precursors to a serious disease or condition, such as Pap smear tests (marker for cervical cancer) or prostate specific antigen tests (marker for prostate cancer).

 (3) Subsection (2) does not apply to the device if it is also to be used for any other purpose including any of the following purposes:

 (a) for testing for a disease or condition as part of a public health screening program sponsored by the government of the Commonwealth or a State or Territory;

 (b) for self-testing to monitor a diagnosed disease or condition;

 (c) for export only.

Endnotes

Endnote 1—About the endnotes

The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments

Endnote 6—Modifications

Endnote 7—Misdescribed amendments

Endnote 8—Miscellaneous

If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading.

Abbreviation key—Endnote 2

The abbreviation key in this endnote sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended the compiled law. The information includes commencement information for amending laws and details of application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law.

Uncommenced amendments—Endnote 5

The effect of uncommenced amendments is not reflected in the text of the compiled law, but the text of the amendments is included in endnote 5.

Modifications—Endnote 6

If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6.

Misdescribed amendments—Endnote 7

An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7.

Miscellaneous—Endnote 8

Endnote 8 includes any additional information that may be helpful for a reader of the compilation.

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]