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THERAPEUTIC GOODS (MEDICAL DEVICES) AMENDMENT REGULATIONS 2009 (NO. 1) (SLI NO 181 OF 2009)
Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (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. Schedule 5 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Principal Regulations) sets out the table of fees payable under the Act in relation to medical devices.
Paragraph 63(3)(b) of the Act provides, in part, for the reduction of fees in cases identified in the regulations. Paragraph 9.4(2)(b) of the Principal Regulations sets out the fee payable where the Secretary of the Department of Health and Ageing (the Secretary) decides to conduct an abridged conformity assessment of a medical device in prescribed circumstances and to charge a reduced fee for that assessment. Paragraph 9.4(2)(a) of the Therapeutic Goods (Medical Devices) Regulations 2002 allows the Secretary to decide to conduct an abridged conformity assessment of a medical device in prescribed circumstances and to charge a reduced fee for that assessment under paragraph 9.4(2)(b). The Regulations increase the level of that applicable fee by 4.3 per cent.
Schedule 5 to the Principal Regulations provides the list of fees payable 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 (the Register) and initial and subsequent assessments under conformity assessment procedures. These fees reflect the costs incurred by the TGA in performing the various tasks under the Act and the Principal Regulations. The Regulations increase the level of all of the fees in Part 1 of Schedule 5 (General) and Part 2 (Additional Fees) by 4.3 per cent.
The purpose of the Regulations is to increase, by 4.3 per cent, all fees payable in relation to the regulation of medical devices which are required to be included on the Register. In applying the increases, fees have been rounded to the nearest $10 for items under $10,000 in value and to the nearest $100 for items over $10,000 in value.
The increases enable the TGA to recover its costs in administering the Act and continue to meet the Australian Government’s Cost Recovery Guidelines.
The Regulations, when taken together with the amendments to the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Charges) Regulations 1990 (which are the subject of separate Regulations), are expected to increase the fees and charges collected by the TGA by $8.8 million (to $99.9 million) over the 2009-10 financial year.
Details of those Regulations are set out in the Attachment.
Consultations with industry associations and consumer health representatives on the TGA’s draft Business Plan, Budget and proposed Schedule of Fees and Charges were convened at the TGA Industry Consultative Committee meeting on 3 March 2009. The proposals for fees and annual charges were subject to additional bilateral consultation at sectoral bilateral meetings convened between 16 and 19 March 2009.
The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.
The Regulations commence on 10 July 2009.
The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Authority: Subsection 63(1) of the Therapeutic Goods Act 1989
ATTACHMENT
Details of the Therapeutic Goods (MEDICAL DEVICES) Amendment Regulations 2009 (No. 1)
Regulation 1 provides for the Regulations to be referred to as the Therapeutic Goods (Medical Devices) Amendment Regulations 2009 (No. 1).
Regulation 2 provides for the Regulations to commence on 10 July 2009.
Item [1]
This item increases the fee for an abridged conformity assessment, in paragraph 9.4(2)(b) of the Principal Regulations, by 4.3 per cent.
This item also increases the fees for all relevant items in Part 1 of Schedule 5 by 4.3 per cent.
Part 2 of Schedule 5 currently provides for additional fees for assessments that are required to be conducted outside Australia. These fees are currently calculated at a rate of $310 for each hour of preparation by each assessor involved.
This item increases the fee of $310 per hour of preparation by each assessor currently payable under paragraph 2.1(b) of Part 2 of Schedule 5 by 4.3 per cent, to $320.