Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023

made under subsection 41BD(3) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date: 1 January 2024

Includes amendments up to: F2023L01682

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 that shows the text of the law as amended and in force on 1 January 2024 (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 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 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 Register for the compiled law.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

3  Authority

4  Definitions

5  Articles that are not medical devices

Schedule 1—Articles that are not medical devices

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

1  Name

  This instrument is the Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023.

3  Authority

  This instrument is made under subsection 41BD(3) 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;

(b)  therapeutic good.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

fungicide has the same meaning as in the Regulations.

hospital grade disinfectant has the same meaning as in the Regulations.

household grade disinfectant has the same meaning as in the Regulations.

MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002

Regulations means the Therapeutic Goods Regulations 1990.

sporicide has the same meaning as in the Regulations.

sterilant has the same meaning as in the Regulations.

therapeutic vaping device has the same meaning as in the MD Regulations.

therapeutic vaping device accessory has the same meaning as in the MD Regulations.

therapeutic vaping pack has the same meaning as in the Regulations.

therapeutic vaping substance accessory has the same meaning as in the Regulations.

tuberculocide has the same meaning as in the Regulations.

virucide has the same meaning as in the Regulations.

5  Articles that are not medical devices

  For the purposes of the Act, the instruments, apparatus, appliances, software, implants, reagents, materials or other articles, or classes of instruments, apparatus, appliances, software, implants, reagents, materials or other articles, specified in Schedule 1 are not medical devices.


Schedule 1—Articles that are not medical devices

Note: See section 5.

Articles that are not medical devices

Column 1

Column 2

Item

Articles or classes of articles

1

articles incorporating tissues, cells or substances of human origin, other than medical devices incorporating stable derivatives of either human blood or human plasma, that act on, or are likely to act on, the human body in a way that is ancillary to the device

2

articles incorporating viable tissues, cells or substances of animal origin

3

articles that are intended to administer a therapeutic good in such a way that the therapeutic good and the article form a single integral product which is intended exclusively for use in the given combination and that are not reusable (may be multidose)

4

chemical oxygen generators

5

hospital grade disinfectants or household grade disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides

6

in-vivo imaging agents injected, ingested, or otherwise instilled into the body

7

riboflavin products instilled into the eye that are used in the treatment of disorders of the eye which cause structural changes within the cornea

Note: These riboflavin products are used with UV-A light illumination in order to achieve an alteration of the normal chemical process of crosslinking of collagen, with the purpose of making the cornea stronger and more stable.

8

topical applications intended to remove or neutralise chemical, biological or radiological agents used in chemical, biological or radiological warfare

9

unmedicated preparations for topical use for protecting against, or providing relief from, nappy rash symptoms by acting only as a barrier for the skin (whether or not the preparations also have a moisturising action)

10

therapeutic vaping devices or therapeutic vaping device accessories in a therapeutic vaping pack

11

therapeutic vaping substance accessories

 

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 how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

 

Endnote 2—Abbreviation key

 

ad = added or inserted

orig = original

am = amended

par = paragraph(s)/subparagraph(s)

amdt = amendment

/subsubparagraph(s)

c = clause(s)

pres = present

C[x] = Compilation No. x

prev = previous

Ch = Chapter(s)

(prev…) = previously

def = definition(s)

Pt = Part(s)

Dict = Dictionary

r = regulation(s)/rule(s)

disallowed = disallowed by Parliament

reloc = relocated

Div = Division(s)

renum = renumbered

exp = expires/expired or ceases/ceased to have

rep = repealed

effect

rs = repealed and substituted

F = Federal Register of Legislation

s = section(s)/subsection(s)

gaz = gazette

Sch = Schedule(s)

LA = Legislation Act 2003

Sdiv = Subdivision(s)

LIA = Legislative Instruments Act 2003

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

cannot be given effect

SubCh = SubChapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

o = order(s)

commenced or to be commenced

Ord = Ordinance

 

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023

18 Aug 2023

(F2023L01088)

19 Aug 2023

Therapeutic Goods (Articles that are Not Medical Devices) Amendment (Vaping) Declaration 2023

15 Dec 2023

(F2023L01682)

1 Jan 2024

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2……………………………….

rep LA s 48D

s 4……………………………….

am F2023L01682

s 6……………………………….

rep LA s 48C

Schedule 1………………………

am F2023L01682

Schedule 2………………………

rep LA s 48C