Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023
made under subsection 41BD(3) of the
Therapeutic Goods Act 1989
Compilation No. 3
Compilation date: 1 January 2026
Includes amendments: F2025L01530 and F2025L01648
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 2026 (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. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).
Application, saving and transitional provisions
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. Any modifications affecting the law are accessible on the Register.
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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
3 Authority
4 Definitions
5 Articles that are not medical devices
6 Application, saving and transitional provisions
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:
(a) included in the Register;
(b) listed goods;
(c) medical device;
(d) medicine;
(e) Register;
(f) registered goods;
(g) therapeutic goods.
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 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.
vaping device has the meaning given by subsection 41P(1) of the Act.
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.
6 Application, saving and transitional provisions
(1) This section applies to articles in items 13 to 16 of the table in Schedule 1 that, immediately before the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, were included in the Register as a kind of medical device.
(2) Items 13 to 16 of the table in Schedule 1 do not apply to the medical devices mentioned in subsection (1) until the earlier of:
(a) the date on which the goods become registered goods or listed goods; and
(b) 1 January 2031.
(3) Despite subsection (2), the articles mentioned in subsection (1) may be dealt with as if items 13 to 16 of the table in Schedule 1 apply from 1 January 2026, including for the purposes of the following:
(a) an application for the registration or listing of the therapeutic goods;
(b) any applicable provisions in Part 3-2 of the Act in relation to applications for the registration or listing of therapeutic goods.
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 medicine in such a way that the medicine 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 multi‑dose) |
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 |
12 | vaping devices that are pre-filled with a therapeutic vaping substance that form a single integral product which is intended exclusively for use in the given combination and that are not reusable (may be multi-dose) |
13 | toothpastes and other dentifrices that achieve their principal intended action through having an effect by chemical or pharmacological means |
14 | head or body lice treatments that achieve their principal intended action through having an effect by chemical or pharmacological means |
15 | moisturisers and emollients that achieve their principal intended action through having an effect by chemical, metabolic or pharmacological means |
16 | weight loss treatments that are ingested into the body and that affect absorption of calories in the gastrointestinal system by metabolic means |
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 | p = page(s) |
amdt = amendment | para = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub‑subparagraph(s) |
ch = Chapter(s) | pres = present |
cl = clause(s) | prev = previous |
cont. = continued | (prev…) = previously |
def = definition(s) | pt = Part(s) |
Dict = Dictionary | r = regulation(s)/Court 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 |
gaz = gazette | s = section(s)/subsection(s) |
LA = Legislation Act 2003 | /rule(s)/subrule(s)/order(s)/suborder(s) |
LIA = Legislative Instruments Act 2003 | sch = Schedule(s) |
(md not incorp) = misdescribed amendment | SLI = Select Legislative Instrument |
cannot be given effect | SR = Statutory Rules |
mod = modified/modification | sub ch = Sub‑Chapter(s) |
No. = Number(s) | sub div = Subdivision(s) |
Ord = Ordinance | sub pt = Subpart(s) |
| underlining = whole or part not |
| commenced or to be commenced |
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 | — |
Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration 2025 | 21 Jan 2025 (F2025L00027) | 22 Jan 2025 | — |
Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 | 10 Dec 2025 (F2025L01530) | 1 Jan 2026 | — |
Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 3) 2025 | 23 Dec 2025 (F2025L01648) | 1 Jan 2026 | — |
Endnote 4—Amendment history
Provision affected | How affected |
s 2………………………………. | rep LA s 48D |
s 4………………………………. | am F2023L01682; F2025L00027; F2025L01530 |
s 6………………………………. | rep LA s 48C ad F2025L01530 am F2025L01648 |
Schedule 1……………………… | am F2023L01682; F2025L00027; F2025L01530; F2025L01648 |
Schedule 2……………………… | rep LA s 48C |