Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L00767 Regulations Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Therapeutic Goods Act 1989

 

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025

 

The instrument increases fees relating to therapeutic goods to support cost recovery.

 

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, Disability and Ageing (the Department), is responsible for administering the Act.

 

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

Relevantly, the regulations may prescribe fees in respect of matters under the Act, or the regulations made under the Act.

 

The main purpose of the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025 (the Amendment Regulations) is to amend the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations), to increase the fees set out in those respective regulations by 3.2 per cent for the 2025-26 financial year.

 

The 3.2 per cent indexation increase was calculated using the same formula used in most previous years to calculate adjustments to TGA fees and charges. The formula is comprised of the Australian Bureau of Statistics’ Consumer Price Index (50 per cent) and Wage Price Index (50 per cent), both for the year to September 2024. This increase is in line with the TGA’s cost recovery model and complements the Therapeutic Goods (Charges) Amendment (2025 Measures No. 1) Regulations 2025, which increases annual charges for therapeutic goods and licences to manufacture therapeutic goods for 2025‑26.

 

The fees that are prescribed, and that have had indexation applied, are based on the effort involved in processing or undertaking the relevant related service, (such as evaluating an application for marketing approval for a prescription medicine) in order to reflect the recovery of the costs of administering the Act, consistent with the Australian Government Cost Recovery Guidelines (the Guidelines).

 

The Amendment Regulations apply the 3.2 per cent increase to most TGA fees, including for example to: application fees for the registration, listing or inclusion of medicines and biologicals in the Australian Register of Therapeutic Goods (the Register); application fees for licences to manufacture, or to undertake a step in the manufacture of, therapeutic goods other than medical devices; fees relating to the evaluation of therapeutic goods for marketing approval; clinical trial notification fees; application fees for export certificates; and inspection fees for manufacturing premises. The indexed fees are rounded to the nearest dollar.

 

As well as the above indexation-based increases, the Amendment Regulations also reduce four design examination fee items in the MD Regulations. The TGA has undertaken, with significant input from sponsors, a detailed analysis of both its application audit and conformity assessment processes in relation to medical device processes, with a view to implementing shorter target assessment timeframes, streamlined processes and improved transparency. Implementation of the streamlined processes is underway, and the associated fees have been reviewed to identify adjustments to reflect these new processes and the efficiencies realised.

 

Separately, the Amendment Regulations also introduces a new exemption, from the requirement to be included in the Register, for Class 4 in-house in-vitro diagnostic (IVD) medical devices that are intended to test a person for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or COVID-19 to determine their suitability to donate blood, cells, tissues or organs.

 

Details of the Amendment Regulations are set out in the Attachment A. The Amendment Regulations are compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

 

The Act specifies no conditions that need to be satisfied before the power to make the Amendment Regulations may be exercised. The Amendment Regulations are a legislative instrument for the purposes of the Legislation Act 2003.

 

The Amendment Regulations commence on 1 July 2025.

 

Consultation

In relation to consultation, the TGA held bilateral meetings with 13 key industry representative bodies in November 2024 on proposed changes to TGA fees and charges for 2025-26. The industry bodies included Medicines Australia, the Generic and Biosimilar Medicines Association, AusBiotech, the Medical Technology Association of Australia, Consumer Healthcare Products Australia and Complementary Medicines Australia. Most bodies indicated their support for the proposed 3.2 per cent indexation increase.

 

The TGA also undertook public consultation to obtain broader stakeholder feedback, with a consultation paper released on the TGA website and submissions sought over a four-week period from 31 January 2025 to 28 February 2025. The TGA received 13 submissions – 9 from industry representative bodies, 2 from sponsors and manufacturers of therapeutic goods, and 1 from a regulatory affairs consultant and 1 from a consumer. Eleven respondents did not raise concerns, while 2 did not support the indexation increase. After considering submissions, the indexation increase is proposed because it is consistent with the Guidelines and critical to achieving full cost recovery of administering the regulatory scheme given rising costs, the need to avoid reducing service delivery to industry, and the efficient operation of the TGA’s activities.

 

Targeted consultation on the need for the proposed new exemption for Class 4 IVD medical devices for testing prospective blood, tissue, cell or organ donors for COVID-19 was undertaken with the Australian organ and tissue authority and relevant laboratory sectors, with stakeholder support for the proposal.

 

Authority: Subsection 63(1) of the Therapeutic Goods Act 1989

ATTACHMENT A

 

Details of the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025

 

Section 1 – Name

This section provides that the title of the Regulations is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025 (the Amendment Regulations).

 

Section 2 – Commencement

This section provides that the Amendment Regulations commence on 1 July 2025.

 

Section 3 – Authority

This section provides that the Amendment Regulations are made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 – Schedules

This section provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and that any other item in a Schedule to the instrument has effect according to its terms.

 

Schedule 1 – Amendments

 

Part 1 – Amendments relating to fees

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

The MD Regulations provide for a number of matters in relation to the regulation of medical devices, including, relevantly, a schedule of fees relating to applications or requests under the Act in connection with medical devices. 

 

Items [1] and [2] – Subregulation 9.1AA(1), and subregulation 9.1AA(2) (method statement, step 2)

These items amend subregulations 9.1AA(1) and (2) of the MD Regulations to update the figure used for calculating a reduced fee amount that is applicable in certain circumstances set out in paragraph 9.1AA. The figure, which appears in subregulation 9.1AA(1) and the accompanying method statement in subparagraph 9.1AA(2), is updated from $31 to $32.

 

Item [3] – Paragraph 2.1(b) of Schedule 5

Item 3 amends paragraph 2.1(b) of Schedule 5 to the MD Regulations, to update the fee which applies to an assessment that is required to be conducted outside Australia, from an hourly rate of $496 to $512, to reflect the 3.2 per cent indexation-based increase from 1 July 2025.

 

Item [4] – Amendments of listed provisions—Part 1 of Schedule 5

Item 4 sets out a table of amendments to listed provisions of Part 1 of Schedule 5 to the MD Regulations. The effect of these amendments is to increase the fees for all relevant items by the indexation rate of 3.2 per cent, from 1 July 2025.
 


Therapeutic Goods Regulations 1990

 

The TG Regulations provide for a number of matters relating to the regulation of therapeutic goods other than medical devices (in practice, principally medicines and biologicals), including, relevantly, schedules of fees relating to applications or requests under the Act in connection with such goods. 

 

Item [5] – Amendments of listed provisions

Item 5 sets out a table of amendments to listed provisions of the TG Regulations.

 

Table item 1 applies a 3.09 percent indexation-based increase to the relevant fee from 1 July 2025. This indexation rate differs from the standard 3.2 percent increase applied elsewhere in the Amendment Regulations, as it relates to the turnover threshold for a holder of a manufacturing licence in relation to their eligibility or otherwise for the reduction mechanism in subregulation 43AAJ(2) of the TG Regulations. 

 

The rest of the amendments in the table in Item 5 of the Amendment Regulations increase the fees for all relevant items by the indexation rate of 3.2 per cent from 1 July 2025.

 

Items [6]-[9]– Amendments of listed provisions – clause 3 of Schedule 9, clause 4 of Schedule 9, clause 5 of Schedule 9, and Part 2 of Schedule 9A

Items 6 to 9 set out tables of amendments to listed provisions of the TG Regulations.

 

The effect of these amendments is to increase the fees for all relevant items by the indexation rate of 3.2 per cent, from 1 July 2025.

 

Part 2–Other amendments

 

Division 1–Main amendments

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Item [10] – Part 2 of Schedule 4 (at the end of the table)

 

On 15 March 2023, the Therapeutic Goods (Medical Devices–Donor Screening) (COVID-19 Emergency) Exemption 2023 (the Emergency Exemption) was made under section 41GS of the Act to deal with the threat to public health caused by the COVID-19 emergency. This notifiable instrument relevantly exempted certain kinds of in-vitro diagnostic (IVD) medical devices that are used for donor screening purposes from the requirement to be included in the Register.

 

Specifically, the Emergency Exemption applied in relation to Class 4 in‑house IVD medical devices that are intended to be used to detect the presence of, or exposure to SARS-CoV-2, for the purpose of assessing the suitability of a person for donating blood, blood components, blood products, cells, tissues or organs, or any other derivatives of these products, of human origin for transfusion or transplantation (the relevant kinds of medical devices).

 

The effect of the Emergency Exemption was to allow accredited pathology laboratories to manufacture or supply the relevant kinds of medical devices, subject to certain conditions, notwithstanding that those devices were not included in the Register and had therefore not been evaluated by the TGA for quality, safety or performance. However, pursuant to its terms, the Emergency Exemption ceased to have effect after 30 June 2024.

 

The ongoing availability of the relevant kinds of medical devices is critical to minimising the risk of recipients of blood, blood components, blood products, cells, tissues or organ contracting SARS‑CoV‑2 in connection with receiving the relevant product.

 

This item introduces new item 2.19 in the table in Part 2 of Schedule 4 to the MD Regulations, to conditionally exempt the relevant kinds of medical devices from the requirement to be included in the Register. The conditions that apply in relation to this exemption are comparable to the conditions for the exemption of Class 4 in-house IVD medical devices in item 2.10A of Part 2 of Schedule 4 to the MD Regulations.

 

In particular:

 

  • the device must be manufactured or supplied only by an accredited pathology laboratory (within the meaning of subsection 3(1) of the Health Insurance Act 1973);
  • the manufacturer or supplier of the device must keep records relating to the manufacture, supply or both (as applicable) of the device, and provide these records to the Secretary if requested;
  • if manufacture of the device commences on or after 1 July 2025, the device must comply with the essential principles, and the manufacturer of the device must apply the appropriate conformity assessment procedures in relation to the device at all times;
  • the manufacturer of the device must, if requested by the Secretary, provide the following information within 20 working days of receiving the request:
    • if manufacture of the device commences on or after 1 July 2025—whether the device complies with the essential principles and the conformity assessment procedures have been applied to the device; and
    • regardless of when manufacture of the device commenced or commences—whether the device complies with every applicable requirement relating to advertising under Part 5-1 of the Act or the TG Regulations;
  • the manufacturer must have the following information available at all times:
    • if manufacture of the device commences on or after 1 July 2025—sufficient information to substantiate that the conformity assessment procedures have been applied to the device; and
    • regardless of when manufacture of the device commenced or commences—information relating to any changes to the device and quality management system;
  • the manufacturer must allow an authorised person to do any of the following:
  • enter, at any reasonable time, any premises at which the device is manufactured or from which the device is supplied;
  • inspect the premises and the device, and examine, take measurements of, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device;
  • make any still or moving image or any recording of those premises or anything on those premises;
  • the manufacturer or supplier must produce any documents relating to the device if asked to do so by an authorised person and allow the authorised person to copy the documents; and
  • the Secretary must not have directed that supply cease because the supply compromises public health and safety.

 

The conditions in paragraphs (e), (g) and (h) in column 3 of new table item 2.19 are necessary to ensure that the TGA can obtain information to determine whether a relevant kind of medical device complies with the essential principles, and that the manufacturer has applied the appropriate conformity assessment procedures to the device. This is critical to ensuring that relevant kinds of medical devices remain safe for use, and is necessary to facilitate a more timely and cooperative information exchange between the TGA and persons who voluntarily participate in the therapeutic goods regulatory scheme.

 

This is particularly important as the relevant kinds of medical devices have not been subject to pre‑market scrutiny before being able to be lawfully used in connection with patients requiring donations of critical materials such as blood or organs in Australia. Without these conditions, there is a risk that the Secretary will not have sufficient information to monitor the safety, quality or performance of these kinds of medical devices. This is of particular concern given the critical use of these medical devices in ensuring the safety of donated blood, tissues, cells and organs for recipients. If one of these Class 4 IVDs did not comply with the essential principles and as a result did not function as intended, it is possible that a vulnerable patient could contract COVID-19 as a result, with potentially grave or even fatal consequences.

 

The conditions in paragraphs (e) and (h) to request certain information, and paragraph (g) to enter certain premises and carry out an inspection, in column 3 of new table item 2.19 would be exercised in circumstances where the TGA:

 

  • receives information that suggests that the device may be unsafe for use, or that the manufacturer of a relevant kind of medical device may not have applied the appropriate conformity assessment procedures, or that such a device may not comply with the essential principles; or
  • undertakes compliance monitoring and investigation activities in respect of a relevant kind of medical device to verify that the device complies with the essential principles, that the appropriate conformity assessment procedures have been applied, and that the quality and safety of the device is acceptable.

 

Additionally, it is appropriate that the conditions in paragraphs (g) and (h) are contained in delegated legislation, rather than primary legislation, because:

 

  • these paragraphs establish conditions for the new exemption. This exemption is made under subsection 41HA(2) of the Act, which provides that such an exemption may be subject to conditions that are prescribed in the regulations;
  • the Act therefore anticipates that the exemption may be prescribed in the regulations subject to conditions. These conditions are intended to be specified in the regulations. It is not desirable to fragment conditions attaching to an exemption across the Act and the regulations. Rather, it is preferrable for conditions to remain attached to the relevant exemption; and
  • the inclusion of these conditions of exemption are appropriately limited to the relevant medical devices specified in new table item 2.19. These conditions are more confined than, for example, the general power to request information or documents under section 45AB of the Act.

Requesting certain information

 

Paragraph (e) in column 3 of new table item 2.19 enables the Secretary to request that the manufacturer of a relevant kind of medical device produce information demonstrating compliance with the essential principles and application of the conformity assessment principles in relation to that device. Upon receipt of such a request, the manufacturer must provide the requested information within 20 working days.

 

Paragraph (h) in column 3 of new table item 2.19 enables an authorised person under the MD Regulations to request that the manufacturer or supplier of a relevant kind of medical device produce any documents relating to the device that the authorised person requires. Once in receipt of such documents, the authorised person would be permitted to make copies of the same.

 

The inclusion of these conditions obligating the provision of information in delegated legislation is critical to the TGA’s ability to gather relevant information concerning relevant kinds of medical devices in a timely and effective manner. Specifically, the inclusion of paragraphs (e) and (h) in new table item 2.19 is necessary and appropriate because:

 

  • the TGA may be unable to request information or documents relating to relevant kinds of medical devices through alternative mechanisms, such as statutory notices issued under section 45AB of the Act, if there is insufficient information available regarding possible contraventions of the Act, TG Regulations or MD Regulations; or
  • in comparison to more formal means of requiring the production of information, programmed compliance monitoring may in certain circumstances facilitate a more cooperative exchange of information between manufacturers and suppliers of relevant kinds of medical device and the TGA.

 

The TGA’s ability to gather information in a timely and complete manner is particularly important when responding to a safety signal, noting that swift regulatory action may be critical to protecting public health and safety. As noted above, non-compliance of a relevant kind of medical device with the essential principles, or a failure to apply the appropriate conformity assessment procedures to such a device, may have potentially grave consequences for patients.

 

If either of these conditions are not complied with, the exemption cannot be relied upon to support the lawful supply of the devices. A person relying on an exemption, but who does not meet the obligations imposed on them through the conditions of the exemption, will lose the benefit of the exemption. Other regulatory action for on-compliance with a condition of an exemption may also be taken.

 

Entry and inspection of premises

 

Paragraph (g) in column 3 of new table item 2.19 enables authorised persons under the MD Regulations to enter and, among other things, inspect any premises at which a relevant kind of medical device is manufactured, or from which such a device is supplied, by an accredited pathology laboratory.

 

The AGD Guide was considered when drafting paragraph (g). In particular, paragraph 8.6 provides that the Commonwealth Parliament has accepted powers to enter premises without express consent or a warrant in certain limited circumstances. Such circumstances apply in relation to the discretionary powers in paragraph (g), as the circumstances in which these powers are enlivened are analogous to circumstances relating to licensed premises discussed in paragraph 8.6 of the AGD Guide.

 

Specifically, licence or registration holders referred to in the AGD Guide are not dissimilar to manufacturers and suppliers of relevant kinds of medical devices. Both categories of persons have chosen to voluntarily subject themselves to conditions or regulatory requirements under a legislative scheme. By complying with the conditions imposed by new table item 2.19, accredited pathology laboratories would be permitted to lawfully manufacture or supply relevant kinds of medical devices in Australia without having to apply for inclusion in the Register.

 

The condition obligating the manufacturer or supplier to facilitate inspection of a site ensures that the TGA can appropriately monitor compliance with applicable regulatory requirements. Additionally, inspection is an efficient way for the TGA to monitor compliance, rather than requiring rounds of statutory notices, for example issued under section 45AB of the Act. The authorised person’s ability to enter and inspect in paragraph (g) is limited in nature and do not confer broad powers to seize documents and other evidential material, in contrast to analogous powers in the Act to enter and, among other things, search premises (see the condition of inclusion imposed by subsection 41FN(1), for example).

 

As outlined above, manufacturers and suppliers of relevant kinds of medical devices have chosen to rely on an exemption to support the lawful supply of the devices, whereby participation in the regulated market and obtaining the benefit of an exemption is contingent on them reasonably and appropriately complying with their obligations imposed through the conditions of the exemption. Manufacturers and suppliers may alternatively choose not to rely on the exemption in new table item 2.19 and instead apply for the inclusion of their device in the Register.

 

Importantly, if an accredited pathology laboratory purporting to rely on the exemption in new table item 2.19 refuses to comply with the condition imposed by paragraph (g), authorised persons cannot compel them to do so. In refusing to comply, however, the exemption cannot be relied upon to support the lawful supply of the devices. A person relying on an exemption, but who does not meet the obligations imposed on them through the conditions of the exemption, will lose the benefit of the exemption. The accredited pathology laboratory may also be committing an offence against section 41MN of the Act, or be liable to a civil penalty under section 41MNA of the Act.

 

In practice, authorised persons conducting site inspections under paragraph (g) would possess the relevant training, skills and experience to carry out regulatory investigations and/or compliance action. Additionally, in accordance with section 52 of the Act, all authorised persons must be issued with an identity card. It is expected that, consistent with analogous powers concerning other therapeutic goods in the Act and its regulations, authorised persons will carry and, on request, present identity cards to persons prior to entering and inspecting any premises of a kind mentioned in paragraph (g). Further, authorised persons must comply with applicable Commonwealth, state and territory codes of conduct.

 


Considerations when requesting information or conducting an inspection

 

It is anticipated that, when deciding whether to request information under paragraphs (e) or (h), or carry out an inspection under paragraph (g), authorised persons or, where relevant, the Secretary or their delegates, would consider the following factors:

 

  • the reliability and extent of information that the TGA possesses with respect to the relevant kind of medical device, including information from the sponsor of the device and third parties;
  • the seriousness of any potential non-compliance with the essential principles or applicable conformity assessment procedures (if known), including whether, and to what degree, the non-compliance may pose a risk to the health or safety of patients;
  • the manufacturer’s reputation and any history of non-compliance with the Act, the TG Regulations and the MD Regulations, or corresponding state or territory laws;
  • whether the TGA has previously exercised these powers in respect of the relevant kind of medical device, and if so, the outcomes in relation to the exercise of those powers;
  • the impact of the exercise of these powers on the manufacturer or supplier, including the time and costs of compliance with the conditions of the exemption;
  • the availability, appropriateness and efficacy of any alternative regulatory compliance and/or enforcement action, such as obtaining a warrant if there are legal grounds to do so, as well as alternative options such as engaging with a manufacturer or supplier on an informal basis;
  • the significance and implications of any anticipated regulatory outcomes (if known), including with respect to the availability of other relevant kinds of medical devices (i.e., for use in screening potential organ and tissue donors for SARS-CoV-2);
  • the time and expense involved for the TGA to exercise these powers, such as the cost of travel to a manufacturing site.

 

Further, the requesting of information or carrying out of an inspection must be legally reasonable and, as a matter of policy, have a clear regulatory purpose. In practice, it is anticipated that the production of information will obviate the need for authorised persons to enter and inspect premises. However, the condition in paragraphs (g) permits this if needed.

 

Item [11] – In the appropriate position in Part 11

 

This item introduces new Division 11.25 in the MD Regulations to provide for the application of the amendments to the MD Regulations that are made by Part 2 of Schedule 1 to the Amendment Regulations.

 

New Division 11.25 contains regulation 11.86, which provides that the amendment of Schedule 4 to the MD Regulations applies in relation to therapeutic goods on and after 1 July 2025 regardless of whether the goods were manufactured before, on or after that day.


 

ATTACHMENT B

 

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025

 

This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the Legislative Instrument

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, Disability and Ageing (the Department), is responsible for administering the Act.

 

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

Relevantly, the regulations may prescribe fees in respect of matters under the Act, or the regulations made under the Act.

 

The main purpose of the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025 (the Amendment Regulations) is to amend the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations), to increase the fees set out in those respective regulations by 3.2 per cent for the 2025-26 financial year.

 

The 3.2 per cent indexation increase was calculated using the same formula used in most previous years to calculate adjustments to TGA fees and charges. The formula is comprised of the Australian Bureau of Statistics’ Consumer Price Index (50 per cent) and Wage Price Index (50 per cent), both for the year to September 2024. This increase is in line with the TGA’s cost recovery model and complements the Therapeutic Goods (Charges) Amendment (2025 Measures No. 1) Regulations 2025, which increases annual charges for therapeutic goods and licences to manufacture therapeutic goods for 2025‑26.

 

The fees that are prescribed, and that have had indexation applied, are based on the effort involved in processing or undertaking the relevant related service, (such as evaluating an application for marketing approval), in order to reflect the recovery of the costs of administering the Act, consistent with the Australian Government Cost Recovery Guidelines (the Guidelines).

 

The Amendment Regulations apply the 3.2 per cent increase to most TGA fees, for example, to: application fees for the registration; listing or inclusion of medicines and biologicals in the Australian Register of Therapeutic Goods (the Register); application fees for licences to manufacture, or to undertake a step in the manufacture of, therapeutic goods other than medical devices; fees relating to the evaluation of therapeutic goods for marketing approval; clinical trial notification fees; application fees for export certificates; and inspection fees for manufacturing premises. The indexed fees are rounded to the nearest dollar.

 

As well as the above indexation-based increases, the Amendment Regulations also reduce four design examination fee items in the MD Regulations. The TGA has undertaken, with significant input from sponsors, a detailed analysis of both its application audit and conformity assessment processes in relation to medical device processes, with a view to implementing shorter target assessment timeframes, streamlined processes and improved transparency. Implementation of the streamlined processes is underway, and the associated fees have been reviewed to identify adjustments required to reflect these new processes and the efficiencies realised.

 

Separately, the Amendment Regulations also introduces a new exemption, from the requirement to be included in the Register, for Class 4 in-house in-vitro diagnostic (IVD) medical devices that are intended to test a person for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or COVID-19 to determine their suitability to donate blood, cells, tissues or organs.

 

Human rights implications

In relation to the amendments to fees, the Amendment Regulations do not introduce any changes to the TG Regulations or MD Regulations other than to implement the fees-related changes outlined above and as such, they do not engage any of the applicable rights or freedoms.

 

In relation to the new exemption for Class 4 IVD in-house medical devices intended to test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or COVID-19 for the purpose of assessing suitability of a person to donate specified biologicals of human origin from requiring to be included in the Register, the Amendment Regulations engage the right to health in Article 12 of the International Covenant on Economic, Social and Cultural Rights (the ICESCR).

 

The right to health

 

The Amendment Regulations engage the right to health in Article 12 of the ICESCR. Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standard of physical and mental health and includes an obligation on state parties to take reasonable measures within available resources to progressively secure broader enjoyment of the right.

 

In General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a ‘fundamental human right indispensable for the exercise of other human rights’, and that the right to health is not to be understood as the right to be health, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.

 

The Amendment Regulations take positive steps to enable continued access to unapproved therapeutic goods used to detect SARS-CoV-2 for the purpose of assessing suitability of a person to donate blood, cells, tissues and organs. The ongoing availability of the relevant kinds of medical devices is critical to minimising the risk of organ recipients contracting SARS‑CoV‑2 and therefore, enabling the supply of safe transfusions and transplantations in Australia.

 

The Amendment Regulations, therefore, take positive steps to support the right to health. 

 

Conclusion

The Amendment Regulations are compatible with human rights because they maintain and support the right to health in Article 12 of the ICESCR as outlined above, and otherwise do not raise any other human rights issues.

 

Mark Butler, Minister for Health and Ageing

 

 

Interactions

Authorises

All Versions

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.