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Specifications as amended, taking into account amendments up to Therapeutic Goods (Medical Devices—Excluded Purposes) Amendment (COVID-19 Rapid Antigen IVD Medical Devices for Self-Testing) Specification 2021
Administered by: Health
Registered 05 Oct 2021
Start Date 01 Oct 2021
Table of contents.

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Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020

made under section 41BEA of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date:                            1 October 2021

Includes amendments up to:            F2021L01347

 

 

 


About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020 that shows the text of the law as amended and in force on 1 October 2021 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

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

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.


Contents

1  Name........................................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

4A  Excluded purposes—Class 1 IVD medical devices............................................................... 1

5  Excluded purposes—Class 2 IVD medical devices.................................................................. 2

6  Excluded purposes—Class 3 and 4 IVD medical devices........................................................ 2

Schedule 1—Excluded purposes                                                        3

Part 1A—Class 1 IVD medical devices                                                                       3

Part 1—Class 2 IVD medical devices                                                                          3

Part 2—Class 3 and 4 IVD medical devices                                                                4

Endnotes                                                                                                                        5

Endnote 1—About the endnotes                                                                              5

Endnote 2—Abbreviation key                                                                                 6

Endnote 3—Legislation history                                                                              7

Endnote 4—Amendment history                                                                             8

 


1  Name

                   This instrument is the Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020.

3  Authority

                   This instrument is made under section 41BEA of the Therapeutic Goods Act 1989.

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.

4A  Excluded purposes—Class 1 IVD medical devices

             (1)  This section applies in relation to medical devices that are:

                     (a)  IVD medical devices for self-testing; and

                     (b)  Class 1 IVD medical devices; and

                     (c)  not intended to be used exclusively for testing to monitor a disease or condition that has been diagnosed by a suitably qualified health professional; and

                     (d)  not intended exclusively for export; and

                     (e)  not intended to be used exclusively for testing as part of a government health screening program.

            (2)   The purposes mentioned in Part 1A of Schedule 1 are specified for the purposes of paragraph 41FD(ia) and subsection 41FF(1A) of the Act.

5  Excluded purposes—Class 2 IVD medical devices

             (1)  This section applies in relation to medical devices that are:

                     (a)  IVD medical devices for self-testing; and

                     (b)  Class 2 IVD medical devices; and

                     (c)  not intended exclusively for export; and

                     (d)  not intended to be used exclusively for testing as part of a government health screening program.

            (2)   The purposes mentioned in Part 1 of Schedule 1 are specified for the purposes of paragraph 41FD(ia) and subsection 41FF(1A) of the Act.

6  Excluded purposes—Class 3 and 4 IVD medical devices

             (1)  This section applies in relation to medical devices that are:

                     (a)  IVD medical devices for self-testing; and

                     (b)  Class 3 IVD medical devices or Class 4 IVD medical devices; and

                     (c)  not intended to be used exclusively for testing to monitor a disease or condition that has been diagnosed by a suitably qualified health professional; and

                     (d)  not intended exclusively for export; and

                     (e)  not intended to be used exclusively for testing as part of a government health screening program.

            (2)   The purposes mentioned in Part 2 of Schedule 1 are specified for the purposes of paragraph 41FD(ia) and subsection 41FF(1A) of the Act.


 

Schedule 1—Excluded purposes

Part 1A—Class 1 IVD medical devices

Note:       See section 4A.

 

Excluded purposes

Column 1

Column 2

Item

Purposes

1

testing specimens from the human body in relation to a serious disease, other than to:

(a)   test for the presence of, or exposure to, any of the following pathogenic organisms or transmissible agents:

(i)       chlamydia trachomatis;

(ii)      hepatitis B virus;

(iii)     hepatitis C virus;

(iv)     herpes simplex virus type 1 and 2;

(v)      human immunodeficiency virus type 1 and type 2;

(vi)     seasonal influenza virus;

(vii)    neisseria gonorrhoea;

(viii)   treponema pallidum (syphilis); or

(b)   diagnose, aid in diagnosis of, indicate the presence of, or test for the presence of markers that are precursors to, any of the following diseases or conditions, other than by genetic testing:

(i)       diabetes;

(ii)      kidney disease;

(iii)     cardiovascular disease; or

(c)   in relation to a device supplied on or after 1 November 2021—test for the presence of SARS-CoV-2 antigens

Part 1—Class 2 IVD medical devices

Note:       See section 5.

 

Excluded purposes

Column 1

Column 2

Item

Purposes

1

testing for faecal occult blood

 

Part 2—Class 3 and 4 IVD medical devices

Note:       See section 6.

 

Excluded purposes

Column 1

Column 2

Item

Purposes

1

testing specimens from the human body, other than to:

(a)   test for the presence of, or exposure to any of the following pathogenic organisms or transmissible agents:

(i)       chlamydia trachomatis;

(ii)      hepatitis B virus;

(iii)     hepatitis C virus;

(iv)     herpes simplex virus type 1 and 2;

(v)      human immunodeficiency virus type 1 and type 2;

(vi)     seasonal influenza virus;

(vii)    neisseria gonorrhoea;

(viii)   treponema pallidum (syphilis); or

(b)   diagnose, aid in diagnosis of, indicate the presence of, or test for the presence of markers that are precursors to, any of the following diseases or conditions, other than by genetic testing:

(i)       diabetes;

(ii)      kidney disease;

(iii)     cardiovascular disease; or

(c) in relation to a device supplied on or after 1 November 2021—test for the presence of SARS-CoV-2 antigens

 


 

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key                                                                      

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key 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 (or will amend) the compiled law. The information includes commencement details for amending laws and details of any 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 (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

    /sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

exp = expires/expired or ceases/ceased to have

reloc = relocated

    effect

renum = renumbered

F = Federal Register of Legislation

rep = repealed

gaz = gazette

rs = repealed and substituted

LA = Legislation Act 2003

s = section(s)/subsection(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

(md) = misdescribed amendment can be given

Sdiv = Subdivision(s)

    effect

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

    cannot be given effect

Sub‑Ch = Sub‑Chapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

 

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020

9 Sep 2020 (F2020L01150)

1 Oct 2020

Therapeutic Goods (Medical Devices—Excluded Purposes) Amendment (COVID-19 Rapid Antigen IVD Medical Devices for Self‑Testing) Specification 2021

29 Sep 2021 (F2021L01347)

1 Oct 2021

 


 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2........................................

rep LA s 48D

s 4........................................

am F2021L01347

s 4A.....................................

s 7........................................

ad F2021L01347

rep LA s 48C

Schedule 1...........................

Schedule 2...........................

am F2021L01347

rep LA s 48C