Therapeutic Goods (Medical Devices) Amendment Regulations 2005 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2005L02313 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Select Legislative Instrument 2005 No. 193

 

Issued by the Authority of the Parliamentary Secretary to the Minister for

Health and Ageing

 

Therapeutic Goods Act 1989

 

Therapeutic Goods (Medical Devices) Amendment Regulations 2005 (No. 1)

 

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 and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The Therapeutic Goods Administration (the TGA) 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.  Paragraph 63(2)(h) of the Act provides that the regulations may prescribe fees in respect of matters under the Act or the regulations.  Paragraph 63(3)(b) of the Act provides, in part, for the reduction of fees in cases identified in the regulations. 

 

Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) provides the list of fees chargeable under Chapter 4 (Medical Devices) of the Act.  The fees payable pursuant to Schedule 5 include the processing of applications for inclusion of medical devices in the Australian Register of Therapeutic Goods and initial and subsequent assessments under the conformity assessment procedures.  These fees reflect the cost incurred by the TGA in performing the various tasks under the Act and the Principal Regulations. 

 

Subregulation 9.4(2) of the Principal Regulations allows the Secretary of the Department of Health and Ageing to conduct an abridged conformity assessment of a medical device in prescribed circumstances and to charge a reduced fee for that assessment, currently $2,670. 

 

The purpose of the Regulations is to increase, by 1.6 per cent, the fees payable in relation to medical devices listed in Schedule 5, and the reduced fee in subregulation 9.4(2).  These fees predominately relate to conformity assessments, application audit assessments and applications in relation to clinical trials of medial devices. These fees are increased annually, and the proposed increases would enable the TGA to continue to meet the Government’s requirement that the TGA operate on a full cost-recovery basis.

 

The increase in fees is usually calculated by adding together 50 per cent of the annual Wage Cost Index (WCI) for the preceding year ended December and 50 per cent of the Consumer Price Index (CPI) for the preceding year ended December, which would work out to be a 3.1 per cent increase on this occasion.  However, given the level of operating reserves of the TGA and the demands on industry in preparing for the new Trans Tasman Joint Agency, the increase in charges is limited to 1.6 per cent.

 

The level of fees was reviewed in consultation with industry associations, including Medicines Australia, the Generic Medicines Industry of Australia, the Australian

Self-Medication Industry, the Complementary Healthcare Council of Australia and the Medical Industry Association of Australia. Industry associations had agreed to the WCI/CPI formula being applied to fees as the basis for a 3.1 per cent increase.  Industry associations would not oppose limiting the overall increase to 1.6 per cent.

 

The new fees have been rounded to ten dollar increments (for amounts up to ten thousand dollars) or one hundred dollar increments (for amounts of ten thousand dollars or more).   

 

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

 

Details of the Regulations are set out in the Attachment.

 

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003. 

 

The Regulations commence on the day after they are registered on the Federal Register of Legislative Instruments.

 

 


ATTACHMENT

 

Details of the Therapeutic Goods (Medical Devices) Amendment Regulations

2005 (No. 1)

 

Regulation 1 – Name of Regulations

 

This regulation provides that the title of the Regulations is the Therapeutic Goods (Medical Devices) Amendment Regulations 2005 (No. 1)

 

Regulation 2 – Commencement

 

This regulation provides for the Regulations to commence on the day after they are registered on the Federal Register of Legislative Instruments.

 

Regulation 3 – Amendment of the Therapeutic Goods (Medical Devices) Regulations 2002  

 

This regulation provides that the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) are amended as set out in the Schedule.                                                                                                                                                                                     

Schedule 1 - Amendments

 

Item [1] – Paragraph 9.4 (2) (b)

 

This item amends paragraph 9.4(2)(b), to increase the level of reduced fees that apply for an abridged conformity assessment by 1.6 per cent, from $2,670 to $2,710.

 

Item [2] – Schedule 5, Part 1, column 4

 

This item increases the fees for all items of in Part 1 of Schedule 5 to the Principal Regulations by 1.6 per cent.

 

Item [3] - Schedule 5, Part 1, paragraph 2.1 (b)

 

This item increases the hourly rate for assessments conducted outside Australia by

1.6 per cent, from $280 to $290 per hour.

 

Overview

The Therapeutic Goods (Medical Devices) Amendment Regulations 2005 (No. 1) were enacted to address the need for regular updates to the fees associated with medical device regulation in Australia, ensuring the Therapeutic Goods Administration (TGA) can operate on a full cost-recovery basis. This legislative instrument amends the Therapeutic Goods (Medical Devices) Regulations 2002, which were established under the Therapeutic Goods Act 1989. The Act aims to maintain a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods in Australia, with the TGA responsible for administering the Act. The Regulations increase fees related to conformity assessments, application audit assessments, and clinical trials for medical devices by 1.6 per cent, reflecting the TGA's operating costs. The fee adjustment was determined in consultation with various industry associations and was limited to 1.6 per cent to accommodate industry demands and the TGA's operating reserves. These Regulations were issued by the Authority of the Parliamentary Secretary to the Minister for Health and Ageing and will commence on the day after their registration on the Federal Register of Legislative Instruments.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods that are used in Australia or exported from Australia, establishing a national system of controls for their quality, safety, efficacy, and timely availability. The Therapeutic Goods Administration (TGA), under the purview of the Minister for Health and Ageing, administers this Act. It applies to various entities, including manufacturers, importers, and suppliers of therapeutic goods, ensuring that these goods meet specified standards. The Therapeutic Goods (Medical Devices) Amendment Regulations 2005 (No. 1) extend the application of the Act by amending the fees associated with medical devices, as outlined in Schedule 5 of the Therapeutic Goods (Medical Devices) Regulations 2002. These fees, which cover the processing of applications and assessments, are increased by 1.6% to ensure the TGA can operate on a full cost-recovery basis. The increase is calculated based on a formula comprising the Wage Cost Index and the Consumer Price Index, with the final adjustment made in consultation with industry associations to balance operational costs and industry demands. The Regulations are applicable nationally, as they pertain to goods used or exported from Australia, and commence on the day after their registration on the Federal Register of Legislative Instruments.

Key Provisions

The Therapeutic Goods (Medical Devices) Amendment Regulations 2005 (No. 1) (the Regulations) primarily amend the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) by increasing the fees for medical devices. The Regulations, pursuant to subsection 63(1) of the Therapeutic Goods Act 1989 (the Act), were made under the authority of the Act to prescribe fees in respect of matters under the Act or the Regulations. Regulation 3 of the Regulations provides that the Principal Regulations are amended as set out in the Schedule, which details the fee increases. Specifically, the fees for conformity assessments, application audits, and clinical trials applications for medical devices, listed in Schedule 5 of the Principal Regulations, are increased by 1.6 per cent. Additionally, the reduced fee for an abridged conformity assessment is increased from $2,670 to $2,710, as detailed in Item [1] of the Schedule. The hourly rate for assessments conducted outside Australia is also increased by 1.6 per cent, from $280 to $290 per hour, as noted in Item [3] of the Schedule. The Regulations impose obligations on parties or entities that need to pay the increased fees for medical devices. Manufacturers, importers, and sponsors of clinical trials must now pay higher fees for conformity assessments, application audits, and clinical trials applications. The increased fees reflect the TGA's cost of performing these tasks under the Act and the Principal Regulations. The Regulations require these entities to pay the new fees when submitting applications or undergoing assessments related to medical devices. The Regulations also require the TGA to implement the fee increases and ensure compliance by the relevant parties. The Act and the Regulations do not explicitly outline specific offences, penalties, or consequences for non-compliance with the fee increases. However, failure to pay the correct fees could result in the TGA not processing applications or conducting assessments, which could delay or prevent the marketing and use of medical devices in Australia. The Act and the Regulations aim to ensure that the TGA can operate on a full cost-recovery basis, and non-compliance with the fee requirements could potentially lead to enforcement actions by the TGA. While the Regulations do not specify maximum penalties for non-compliance, the TGA may take appropriate action to ensure compliance with the fee requirements under the Act.

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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.