Therapeutic Goods (Medical Devices—Foreign Countries) Amendment Determination 2026

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act is administered by the Therapeutic Goods Administration (the TGA) within the Australian Government Department of Health, Disability and Ageing (the Department).

Section 41HD of the Act provides that the Secretary may approve the importation into, or the importation and supply in, Australia of specified medical devices that are not included in the Australian Register of Therapeutic Goods (the Register), if the Secretary is satisfied of certain matters. Section 41HD is critical to the Department’s ability to manage and alleviate the potentially serious consequences of medical device shortages in Australia as it facilitates the importation and supply of substitute medical devices for medical devices included in the Register that are unavailable or in short supply, or that may become so in the reasonably foreseeable future.

Under subsection 41HD(1), the Secretary may approve the importation, or importation and supply, of a specified medical device if the Secretary is satisfied that:

the kinds of medical devices included in the Register that could act as a substitute for the specified medical device are unavailable or in short supply, or may, in the reasonably foreseeable future, become unavailable or be in short supply; and
either of the following apply:

 the specified medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection 41HD(5);

 an application has been made in accordance with section 41FC of the Act for inclusion in the Register of the kind of medical device that includes the specified medical device, and that application has passed preliminary assessment; and

the medical device is specified by the Secretary in a determination under subsection 41HD(6) of the Act; and
the approval is necessary in the interests of public health.

The Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026 (the Principal Determination) is a legislative instrument made under subsections 41HD(5) and 41HD(6) of the Act. It specifies, under subsection 41HD(5), the foreign countries in which registration or approval for general marketing of the specified medical devices is required for the purposes of subparagraph 41HD(1)(d)(i) of the Act. It also specifies, under subsection 41HD(6), medical devices that can be the subject of an approval under section 41HD, being devices that are cannulas for use in cardiac surgery or cardiopulmonary bypass procedures.

The Therapeutic Goods (Medical Devices—Foreign Countries) Amendment Determination 2026 (the Amendment Determination) is made under subsection 41HD(6) of the Act. It amends the Principal Determination to:

specify the following as medical devices that can be the subject of an approval under section 41HD of the Act:

 Class I, Class IIa, Class IIb or Class III medical devices;

 Class 1, Class 2, Class 3 or Class 4 in vitro diagnostic (IVD) medical devices; and

make a small number of consequential revisions, including to insert several definitions, and to reflect that new Schedule 2 to the Principal Determination comprises two Parts.

These amendments are prompted by the current Middle East conflict, as there are concerns the conflict may disrupt critical supply chains relating to medical devices that are included in the Register. However, as outlined below, shortages of medical devices can occur for a variety of reasons, and circumstances may arise at any time in the future which require the Department to act quickly to manage shortages (or expected shortages) of a range of medical devices that are needed to support the health of Australians. The Amendment Determination creates a preparedness for the Department to do so – specifically, by giving the Secretary an option to grant an approval under section 41HD for the importation, or importation and supply, of a range of overseas medical devices, if the other preconditions in the relevant subsection are also satisfied.

Background

Shortages of medical devices, including short supply and unavailability of devices, can occur for a number of reasons, ranging from manufacturing issues, logistical difficulties or unexpected increases in demand. Global events also have the potential to affect a range of supply chains. Shortages impede timely availability of medical devices and risk interruption to treatment or surgery, which in turn impacts patient health and causes stress and anxiety for patients and health practitioners who require the affected medical devices. A medical device shortage in Australia could have potentially grave consequences, significantly impacting the health and wellbeing of patients.

Importing and supplying substitute medical devices is an important means of managing and alleviating the effects of a medical device shortage, provided suitable substitute medical devices can be readily obtained from overseas. However, the Act prohibits the importation into, exportation from, or manufacture or supply in, Australia of therapeutic goods that are not registered, listed or included in the Register, unless the goods are exempt from that requirement, or a relevant approval or authority has been granted or applies under the Act – see, relevantly, sections 41MI and 41MIB of the Act in relation to medical devices. A person may commit an offence or be liable to a civil penalty for contravening these provisions.

Section 41HD of the Act provides a legislative basis for the Secretary to approve the importation, or importation and supply, of a specified medical device that is not included in the Register. An approval under section 41HD is an important tool that may facilitate the importation and supply of overseas medical devices that are a substitute for medical devices that are approved for supply, but unavailable or in shortage, in Australia.

Importantly, the Secretary’s exercise of a power under section 41HD is subject to the Secretary’s satisfaction of the matters set out in the relevant subsection. The matters of which the Secretary must be satisfied before granting an approval under section 41HD are important patient health safeguards, noting that the substitute medical devices are not approved for supply in Australia. Those matters, and the ability to impose conditions, ensure there are carefully determined safety-related parameters in place for patients.

Purpose

The Amendment Determination is made under subsection 41HD(6) of the Act. It repeals and replaces Schedule 2 to the Principal Determination to specify the following as medical devices that can be the subject of an approval under section 41HD:

Class I, Class IIa, Class IIb or Class III medical devices; and
Class 1, Class 2, Class 3 or Class 4 IVD medical devices.

The Amendment Determination also amends section 4 of the Principal Determination to insert several definitions that are consequential to the amendments outlined above. Additionally, the Amendment Determination amends subsection 5(2) of the Principal Determination to reflect that new Schedule 2 comprises two Parts.

The Amendment Determination addresses concerns regarding the vulnerability to disruption of critical medical device supply chains, including, for example, as a result of the current conflict in the Middle East. The Department considers there is a heightened risk that, in the reasonably foreseeable future, medical devices included in the Register may become unavailable or be in short supply. This risk applies to medical devices across all medical device classifications. To manage or alleviate the consequences of such shortages, the Secretary may consider granting approvals under section 41HD of the Act for the importation, or importation and supply, of suitable substitute overseas medical devices.

It follows that the Amendment Determination amends the Principal Determination to specify medical devices in all medical device classifications. This provides the Secretary with the option to grant an approval under section 41HD in relation to an overseas medical device, provided the Secretary is also satisfied that the other preconditions set out in the relevant subsection are met. Such preconditions include, for example, that Secretary is satisfied the approval is necessary in the interests of public health.

Consultation

In March and April 2026, the TGA consulted with 46 representatives of key industry peak bodies on a proposal to amend the Principal Determination to specify each medical device classification under subsection 41HD(6) of the Act. Stakeholders included members of the Regulatory and Technical Consultative Forum for medical devices, 20 representatives from state and territory health departments, 8 representatives from private hospitals, and 17 representatives from the Public Health Laboratory Network. All stakeholders were supportive of the proposed amendments and did not provide any objections.

Other details

Details of the Amendment Determination are set out in Attachment A.

The Amendment Determination is 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 Amendment Determination is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences the day after registration on the Federal Register of Legislation.

Attachment A

Details of the Therapeutic Goods (Medical Devices—Foreign Countries) Amendment Determination 2026

Section 1 – Name

This section provides that the name of the instrument is the Therapeutic Goods (Medical Devices—Foreign Countries) Amendment Determination 2026 (the Amendment Determination).

Section 2 – Commencement

This section provides that the Amendment Determination commences the day after registration on the Federal Register of Legislation.

Section 3 – Authority

This section provides that the legislative authority for making the Amendment Determination is subsection 41HD(6) of the Therapeutic Goods Act 1989 (the Act).

Subsection 33(3) of the Acts Interpretation Act 1901 relevantly provides that, where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character, the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument. The Amendment Determination is made in accordance with that provision.

Section 4 – Schedules

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

Schedule 1 – Amendments

This Schedule amends the Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026 (the Principal Determination).

Item 1 amends section 4 of the Principal Determination to insert several definitions. This item is consequential to amendments made below. The definitions inserted by this item include ‘MD Regulations’, which means the Therapeutic Goods (Medical Devices) Regulations 2002, as well as the following definitions that have the same meaning as in those regulations:

‘Class 1 IVD medical device’;
‘Class 2 IVD medical device’;
‘Class 3 IVD medical device’;
‘Class 4 IVD medical device’;
‘Class I medical device’;
‘Class IIa medical device’;
‘Class IIb medical device’;
‘Class III medical device’;
‘IVD medical device’.

Item 2 amends subsection 5(2) of the Principal Determination to insert “Part 1 and Part 2 of” after “specified in”. This item is consequential to amendments made below.

Item 3 repeals Schedule 2 to the Principal Determination, which, under subsection 41HD(6) of the Act, currently specifies medical devices that are cannulas for use in cardiac surgery or cardiopulmonary bypass procedures. In its place, this item substitutes new Schedule 2 to the Principal Determination, which specifies the following as medical devices that can be the subject of an approval under section 41HD:

in Part 1—Class I, Class IIa, Class IIb or Class III medical devices; or
in Part 2—Class 1, Class 2, Class 3 or Class 4 in vitro diagnostic (IVD) medical devices.

These amendments address concerns regarding the vulnerability to disruption of critical supply chains for medical devices, including, for example, because of the current conflict in the Middle East. The Department considers there is a heightened risk that, in the reasonably foreseeable future, medical devices across all medical device classifications may become unavailable or be in short supply. To manage or alleviate the consequences of such shortages, the Secretary may consider granting approvals under section 41HD of the Act for the importation, or importation and supply, of medical devices not included in the Register (overseas medical devices).

The Amendment Determination provides the Secretary with the option to grant an approval under section 41HD in relation to overseas medical devices across all medical device classifications. This creates a preparedness for the Secretary to act quickly to approve the importation, or importation and supply, of overseas medical devices under section 41HD, if such a measure is considered necessary to manage a shortage (or expected shortage) of medical devices included in the Register.

Importantly, before exercising a power under section 41HD, the Secretary must still be satisfied of the other matters set out in the relevant subsection. For example, before granting an approval under subsection 41HD(1), the Secretary must still also be satisfied that:

medical devices included in the Register that could act as a substitute for the overseas medical device are, or may in the reasonably foreseeable future become, unavailable or in short supply; and
the overseas medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection 41HD(5), or is otherwise the subject of an application to the TGA, that has passed preliminary assessment, for the device to be included in the Register; and
the approval is necessary in the interests of public health.

Notably, medical devices that are cannulas for use in cardiac surgery or cardiopulmonary bypass procedures are generally classified as Class IIb or Class III medical devices. Such medical devices are therefore still medical devices that can be the subject of an approval under section 41HD of the Act.

Attachment B

Statement of Compatibility with Human Rights

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

Therapeutic Goods (Medical Devices—Foreign Countries) Amendment Determination 2026

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 legislative instrument

Section 41HD of the Therapeutic Goods Act 1989 (the Act) provides that the Secretary may approve the importation into, or the importation and supply in, Australia of specified medical devices that are not included in the Australian Register of Therapeutic Goods (the Register), if the Secretary is satisfied of certain matters. Section 41HD is critical to the Department’s ability to manage and alleviate the potentially serious consequences of medical device shortages in Australia as it facilitates the importation and supply of substitute medical devices for medical devices included in the Register that are unavailable or in short supply.

Under subsection 41HD(1), the Secretary may approve the importation, or importation and supply, of a specified medical device if the Secretary is satisfied that:

the kinds of medical devices included in the Register that could act as a substitute for the specified medical device are unavailable or in short supply, or may, in the reasonably foreseeable future, become unavailable or be in short supply; and
either of the following apply:

 the specified medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection 41HD(5);

the medical device is specified by the Secretary in a determination under subsection 41HD(6) of the Act; and
the approval is necessary in the interests of public health.

specify the following as medical devices that can be the subject of an approval under section 41HD of the Act:

 Class I, Class IIa, Class IIb or Class III medical devices;

 Class 1, Class 2, Class 3 or Class 4 in vitro diagnostic (IVD) medical devices; and

make a small number of consequential revisions, including to insert several definitions, and to reflect that new Schedule 2 to the Principal Determination comprises two Parts.

Background

Purpose

Class I, Class IIa, Class IIb or Class III medical devices; and
Class 1, Class 2, Class 3 or Class 4 IVD medical devices.

Human rights implications

The Amendment Determination engages the right to health in Article 12 of the International Covenant on Economic, Social and Cultural Rights (the ICESCR). Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standards of physical and mental health and includes an obligation 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 healthy, 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 Determination takes positive steps to promote the right to health by supporting continuity of access to medical devices that are critical for patient care and wellbeing when there is a shortage, or anticipated shortage, of medical devices that are included in the Register. It does so by ensuring that certain matters that the Secretary must be satisfied of before granting an approval under section 41HD of the Act can be satisfied if the need arises for the Secretary to approve the importation or supply of medical devices to manage a shortage or unavailability of medical devices in Australia.

The Amendment Determination addresses concerns regarding the vulnerability to disruption of critical medical device supply chains, including, for example, disruptions caused by the current conflict in the Middle East. The Department considers there is a heightened risk that, in the reasonably foreseeable future, medical devices included in the Register may become unavailable or be in short supply. This risk applies to medical devices across all medical device classifications. To manage or alleviate the consequences of such shortages, the Secretary may consider granting approvals under section 41HD of the Act for the importation, or importation and supply, of suitable substitute overseas medical devices.

It follows that the Amendment Determination specifies all medical device classifications under subsection 41HD(6) of the Act. The effect of these amendments is that medical devices of all classifications can be the subject of an approval granted under section 41HD. This, in turn, will support the right to health through helping Australian patients avoid the suffering that may otherwise occur due to an interruption in treatment for their condition.

Importantly, before granting an approval under section 41HD, the Secretary must also be satisfied that all the other preconditions to the exercise of that power are satisfied. For example, before granting an approval under subsection 41HD(1), the Secretary must also be satisfied that:

medical devices included in the Register that could act as a substitute for the overseas medical device are, or may in the reasonably foreseeable future become, unavailable or in short supply; and
the overseas medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection 41HD(5), or is otherwise the subject of an application to the TGA, that has passed preliminary assessment, for the device to be included in the Register; and
the approval is necessary in the interests of public health.

Conclusion

The Determination is compatible with human rights because it promotes the right to health in Article 12 of the ICESCR and otherwise does not raise any other human rights issues.

Administered by Department of Health, Disability and Ageing

Interactions

Legislation content

Interactions

Authorises

All Versions