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Other as amended, taking into account amendments up to Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Personalised Medical Devices) Instrument 2021
Administered by: Health
Registered 27 Aug 2021
Start Date 21 Aug 2021
Table of contents.

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Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020

made under subsection 41BD(2B) of the

Therapeutic Goods Act 1989

Compilation No. 2

Compilation date:                             21 August 2021

Includes amendments up to:           F2021L01160

 

 


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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

5  Classes of articles specified to be medical devices.................................................................... 1

Schedule 1—Specified classes of articles that are medical devices                            2

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—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)    health practitioner;

(b)    manufacturer;

(c)    medical device;

(d)    supply.

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.

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.

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).


 

 

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



 

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

Application, saving and transitional provisions

Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020

23 Apr 2020

(F2020L00463)

24 Apr 2020

¾

Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Borderline Products—COVID-19) Instrument 2021

30 Jul 2021

(F2021L01048)

31 Jul 2021

¾

Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Personalised Medical Devices) Instrument 2021

20 Aug 2021 (F2021L01160)

21 Aug 2021

¾

 


 

Endnote 4—Amendment history

 

Provision affected

How affected

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

rep LA s 48D

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

am F2021L01160

s 5........................................

am F2021L01048

s 6........................................

rep LA s 48C

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

am F2021L01048; F2021L01160

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

rep LA s 48C