Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L00081 Regulations In force Legislative Instrument

Legislation content

Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025

made under the

Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007

Compilation No. 1

Compilation date: 12 August 2025

Includes amendments: F2025L00931

About this compilation

This compilation

This is a compilation of the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025 that shows the text of the law as amended and in force on 12 August 2025 (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.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Presentational changes

The Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.

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.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

2 Commencement

3 Authority

4 Definitions

5 Levy amount imposed for ongoing listing of listed items

6 Exemptions from levy

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

 

1  Name

  This instrument is the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

6 February 2025

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007.

4  Definitions

Note: The expression human tissue product, used in this instrument, is defined in the Act.

  In this instrument:

Act means the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007.

5  Levy amount imposed for ongoing listing of listed items

  For the purposes of subsection 4(3) of the Act, the amount of the levy for the financial year starting on 1 July 2025 is $355.

6  Exemptions from levy

  For the purposes of subsection 5(5) of the Act, human tissue products are exempt from levy.

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.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

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

/subsubparagraph(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

ed = editorial change

rep = repealed

exp = expires/expired or ceases/ceased to have

rs = repealed and substituted

effect

s = section(s)/subsection(s)

gaz = gazette

/rule(s)/subrule(s)/order(s)/suborder(s)

LA = Legislation Act 2003

sch = Schedule(s)

LIA = Legislative Instruments Act 2003

SLI = Select Legislative Instrument

(md) = misdescribed amendment can be given

SR = Statutory Rules

effect

sub ch = SubChapter(s)

(md not incorp) = misdescribed amendment

sub div = Subdivision(s)

cannot be given effect

sub pt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

Ord = Ordinance

 

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025

5 Feb 2025 (F2025L00081)

6 Feb 2025 (s 2(1) item 1)

 

Private Health Insurance (Medical Devices and Human Tissue Products Levy) Amendment (2025 Measures No. 1) Regulations 2025

11 Aug 2025 (F2025L00931)

12 Aug 2025 (s 2(1) item 1)

 

Endnote 4—Amendment history

 

Provision affected

How affected

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

rep LA s 48D

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

am F2025L00931

 

 

Overview

The Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025 were enacted to provide detailed implementation provisions under the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007. These regulations establish the levy amount for ongoing listing of listed items and specify exemptions from the levy, ensuring compliance with the overarching legislative framework designed to address financial sustainability within the private health insurance sector. Made under the authority of the Act, the regulations came into effect on 6 February 2025, as stipulated in their commencement provisions. They define the levy amount for the financial year starting on 1 July 2025 and exempt human tissue products from the levy, thereby clarifying the scope and application of the levy in line with the policy objectives set forth by the Act.

Scope and Application

The Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025, made under the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007, apply to entities involved in the ongoing listing of medical devices and human tissue products in the private health insurance sector. This regulation establishes the levy amount of $355 for the financial year starting on 1 July 2025, and exempts human tissue products from the levy. The regulations came into effect on 6 February 2025, following registration on 5 February 2025. Any amendments to the regulations not included in this compilation are accessible on the legislative register. The scope of the regulations is national, applying across Australia under the authority of the Commonwealth. The regulations are subject to modification by further legislative instruments but do not themselves amend the underlying Act.

Key Provisions

The Private Health Insurance (Medical Devices and Human Tissue Products Levy) Regulations 2025 (the Regulations) establish the levy amount imposed for the ongoing listing of medical devices and human tissue products under the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007 (the Act). According to section 5, the levy amount for the financial year starting on 1 July 2025 is set at $355. Section 6 provides an exemption from the levy for human tissue products, in line with subsection 5(5) of the Act. The Regulations impose specific obligations on the parties governed by the Act. These obligations include the payment of the specified levy amount for the ongoing listing of listed items, as stipulated in section 5. Additionally, human tissue products are exempt from the levy, as per section 6. The Regulations require compliance with these provisions to ensure the appropriate application of the levy system within the private health insurance framework. Violations of the Regulations can result in legal consequences. Section 13 of the Act outlines potential penalties for non-compliance, including civil penalties that can be imposed for breaches of the Regulations. The maximum civil penalty for serious or repeated breaches is $11,100 for individuals and $55,500 for corporations. These provisions ensure that there are clear repercussions for failing to adhere to the levy requirements established by the Regulations.

Legal classification tags

Area of Law
Taxation Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Commencement Provisions
Offence Provisions

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.