Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020
made under subsection 41BD(2B) of the
Therapeutic Goods Act 1989
Compilation No. 5
Compilation date: 1 January 2026
Includes amendments: F2025L01529
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 Classes of articles specified to be medical devices
6 Application, saving and transitional provisions
Schedule 1—Specified classes of articles that are 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 (Medical Devices—Specified Articles) Instrument 2020.
3 Authority
This instrument is made under subsection 41BD(2B) of the Therapeutic Goods Act 1989.
4 Definitions
Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act including:
(a) conformity assessment certificate;
(b) health practitioner;
(c) included in the Register;
(d) listed goods;
(e) manufacturer;
(f) medical device;
(g) medicine;
(h) Register;
(i) registered goods;
(j) supply;
(k) therapeutic goods.
Note 2: Other grammatical forms of a defined word have a corresponding meaning (see section 18A of the Acts Interpretation Act 1901), for example, manufacturer and manufacture.
In this instrument:
Act means the Therapeutic Goods Act 1989.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
relevant practitioner means a health practitioner, or other person suitably trained or qualified who is acting on the instruction, or at the request, of a health practitioner.
therapeutic cannabis vaping good has the same meaning as in the MD 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.
5 Classes of articles specified to be medical devices
The classes of instruments, apparatus, appliances, software, implants, reagents, materials and other articles mentioned in Schedule 1 are specified to be medical devices for the purposes of paragraph 41BD(1)(ab) of the Act.
Note: The meaning of medical device in section 41BD of the Act includes any article that is included in a class of articles specified under subsection 41BD(2B).
6 Application, saving and transitional provisions
(1) This section applies to therapeutic goods in items 8 to 14 of the table in Schedule 1 that, immediately before the commencement of the Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025, were registered goods or listed goods.
(2) Items 8 to 14 of the table in Schedule 1, as inserted by Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025, do not apply to the therapeutic goods mentioned in subsection (1) until the earlier of:
(a) the date on which the goods are included in the Register as a kind of medical device; and
(b) 1 January 2031.
(3) Despite subsection (2), the therapeutic goods mentioned in subsection (1) may be dealt with in accordance with the amendments made by the Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025, including for the purposes of the following:
(a) an application for a conformity assessment certificate;
(b) an application for inclusion in the Register as a kind of medical device;
(c) any applicable provisions in Part 4-4 of the Act in relation to conformity assessment certificates and Part 4-5 in relation to the inclusion of kinds of medical devices in the Register.
Schedule 1—Specified classes of articles that are medical devices
Note: See section 5.
Specified classes of articles | |
Column 1 | Column 2 |
Item | Specified class |
1 | articles that are non-sterile personal protective equipment or safety apparel (including but not limited to aprons, face masks, gloves, goggles, gowns and visors) intended, by the person under whose name the articles are or are to be supplied, to be used for the prevention of the transmission of disease between persons, including where that intention may be ascertained from the articles being represented as suitable for use in surgery, or clinical, medical or other health services |
2 | 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 the articles 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 |
3 | bedding, clothing, towels and other articles made principally of fabric that are: (a) intended, by the person under whose name the articles are or are to be supplied, to be used primarily on, or in close contact with, the human body; and (b) represented expressly to be effective against the virus that causes coronavirus disease (COVID-19); other than articles that are mattresses, household furnishings, furniture or articles specified in item 1 |
3A | materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner for the direct restoration of teeth, including but not limited to: (a) amalgam; (b) composite resins and respective bonding systems; (c) core build-up materials; (d) crown forms; (e) fibre or metal preformed posts; (f) fibre reinforcement materials; (g) fissure sealants; (h) glass ionomers; (i) liners and bases; (j) resin-modified glass ionomers; (k) temporary crown or bridge materials |
3B | materials and articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner for the indirect restoration of teeth, including but not limited to: (a) ceramic; (b) crown forms; (c) metal alloy; (d) temporary crown or bridge materials |
3C | materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner in the manufacture of externally-applied orthopaedic devices, including but not limited to: (a) fibreglass bandages used in the manufacture of splints or orthoses; (b) software; (c) thermoplastic sheeting used in the manufacture of splints or orthoses |
3D | materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner to manufacture non-implantable dental appliances, including but not limited to: (a) acrylic; (b) denture repair or reline materials; (c) metal alloy used in casting; (d) orthodontic components (such as bands, brackets, chains, elastics, ligature ties, separators and wire); (e) palate expanders; (f) preformed acrylic teeth; (g) preformed clasps; (h) software; (i) thermoplastic; (j) wrought wire used in the manufacture of clasps or retainers |
3E | materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner to obtain dental impressions |
4 | substances that are intended, by the person under whose name the products are or are to be supplied, specifically to be used for disinfecting a medical device |
5 | substances that are intended, by the person under whose name the products are or are to be supplied, to be used only to clean a medical device (other than contact lenses) by means of physical action |
6 | substances that are intended, by the person under whose name the products are or are to be supplied, specifically to be used for disinfecting, cleaning, rinsing or hydrating contact lenses |
7 | articles or components that are, or are likely to be taken to be, for use in the manufacture of therapeutic vaping devices, therapeutic vaping device accessories or therapeutic cannabis vaping goods, including but not limited to the following: (a) mouthpieces; (b) heating elements, for example, coils; (c) batteries; (d) lights; (e) casements; other than bolts, nuts, screws, or other fasteners |
8 | locking solutions to be used in vascular access devices that are intended, by the person under whose name the articles are, or are to be, supplied, to be used solely to maintain the patency of the device |
9 | substances generated by ozone generators that are intended, by the person under whose name the substances are, or are to be supplied, to be used in: (a) sanitising or disinfecting another medical device, or medical equipment; or (b) cleaning of the oral cavity |
10 | pre-filled saline flush syringes where the saline is intended, by the person under whose name the articles are, or are to be, supplied, to be used solely to maintain the patency, or to flush the lumen, of another medical device |
11 | weight loss treatments that are ingested into the body and that achieve their principal intended action only by means of physical action |
12 | head or body lice treatments that achieve their principal intended action only by means of physical action |
13 | toothpastes and other dentifrices that achieve their principal intended action only by means of physical action |
14 | moisturisers and emollients that achieve their principal intended action only by means of physical action |
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 (Medical Devices—Specified Articles) Instrument 2020 | 23 Apr 2020 (F2020L00463) | 24 Apr 2020 | — |
Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Borderline Products—COVID-19) Instrument 2021 | 30 Jul 2021 (F2021L01048) | 31 Jul 2021 | — |
Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Personalised Medical Devices) Instrument 2021 | 20 Aug 2021 (F2021L01160) | 21 Aug 2021 | — |
Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Vaping) Instrument 2023 | 15 Dec 2023 (F2023L01681) | 1 Jan 2024 | — |
Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2024 | 10 Oct 2024 (F2024L01282) | 11 Oct 2024 | — |
Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025 | 10 Dec 2025 (F2025L01529) | 1 Jan 2026 | — |
Endnote 4—Amendment history
Provision affected | How affected |
s 2………………………………. | rep LA s 48D |
s 4………………………………. | am F2021L01160; F2023L01681; F2024L01282; F2025L01529 |
s 5………………………………. | am F2021L01048 |
s 6………………………………. | rep LA s 48C ad F2025L01529 |
Schedule 1……………………… | am F2021L01048; F2021L01160; F2023L01681; F2024L01282; F2025L01529 |
Schedule 2……………………… | rep LA s 48C |