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Fees and charges for IVD medical devices

16 August 2010

Overview

The TGA is fully cost-recovered and collects its revenue primarily through annual charges, application, evaluation, audit and assessment fees. The fees and charges currently applicable to IVD medical devices are available at Fees & Payments.

The TGA is very conscious of the costs associated with its regulatory responsibilities and is continually seeking to contain those costs through improvements in both efficiency and effectiveness. Each year, the level of fees and charges for IVD medical devices1 (IVD) is reviewed in consultation with industry associations, including:

  • the Medical Technology Association of Australia
  • AusBiotech Ltd
  • IVD Australia
  • Australian Dental Industry Association.

Annual charges are payable each financial year for IVDs that are on the Australian Register of Therapeutic Goods (ARTG) for any part of the financial year.

Fees are charged for submission, assessment and audit of new IVD applications. Fees are also payable when there are changes that the TGA needs to assess.

1. The use of the term 'medical device' is taken to include 'IVD medical devices' - the latter term will be used to denote references that are specific to IVD medical devices.

Annual charges

An annual charge is payable for maintaining a medical device in the ARTG. The annual charges may vary depending on the classification of the device. Different rates may apply for a:

  • Class 4 IVD including a Class 4 in-house IVD
  • Class 3 IVD
  • Class 2 IVD
  • Class 1 IVD

However, under the new IVD regulatory framework that commenced on 1 July 2010, annual charges have been set to $0 for all IVD classes until 30 June 2014.

If an IVD is included in the ARTG at any time in a financial year, the annual charge is payable in full. There is no reduction in the annual fee if an IVD is only on the ARTG for part of a year. A new IVD approved during a financial year will be liable for the full annual charge for that financial year, in addition to the application and/or assessment fees paid.

Annual charges are levied as a tax for cost recovery purposes through the Therapeutic Goods (Charges) Act 1989. Invoices for annual charges are generally issued to sponsors in July/August each year for all products on the ARTG as at 1 July of that year.

Sponsors can elect to receive their annual charges invoice electronically by completing the form available at Electronic invoices nomination form. Electronic invoicing improves the timeliness and delivery of invoices.

These invoices will include a complete list of ARTG entries for each sponsor. Any discrepancies or omissions from the list of product entries should be notified to the TGA immediately. Sponsors also have an opportunity to review the devices listed in the invoice and identify any products which should be cancelled (where supply ceased before 1 July of that year) and products for which a waiver of annual fees on the grounds of low value turnover will be sought.

The TGA allows sponsors to spread their liability for annual charges over the financial year by paying in quarterly instalments. Failure to make an instalment payment by the due date means the sponsor forfeits the option of making instalment payments for the remainder of the year. The outstanding amount of the invoice will become payable in full.

Non payment of annual charges for IVDs will result in the cancellation of the relevant products from the ARTG. Once cancelled, a new application would be required to continue to supply the IVD in Australia.

Low value turnover

The annual charge is not payable for low value turnover products. A sponsor must apply to the TGA providing a declaration that the turnover is of low volume and low value to obtain an exemption from the annual charge.

Low value turnover means a turnover of not more than 15 times the applicable annual charge for that IVD. The turnover of an IVD is the gross dollar receipts from sales in Australia for a financial year, exclusive of GST.

Applications for low value turnover exemptions for products on the ARTG at the beginning of the financial year must be accompanied by a statement of actual turnover signed by a person who is a qualified accountant under section 88B of the Corporation Act 2001. There is a non-refundable application fee to declare that a product is of low value. For more information please refer to Guidance on applying for low value turnover exemption from annual charges.

Fees

The TGA has a variety of fees for IVDs. They include:

  • application fees
  • conformity assessment fees
  • application audit (technical file review) fees.

Application fees

To avoid delays, sponsors and manufacturers should pay the application fee at the time of submitting an application. The application will not proceed until the fee is paid.

The fees payable vary depending on the type of application.

The TGA charges application fees to:

  • apply for a TGA Conformity Assessment Certificate
  • include an IVD medical device in the ARTG
  • vary an ARTG entry if the entry is incomplete or incorrect
  • obtain a Certificate of Free Sale or an Export Certificate, which are required by some countries that devices are exported to
  • lodge an application for consent to import into Australia, supply for use in Australia, or export from Australia an IVD that does not conform to the Essential Principles
  • notify the intention to sponsor a clinical trial of an IVD to be used solely for experimental purposes in humans - Clinical Trial Notification Scheme
  • apply for approval to use a specified kind of medical device solely for experimental purposes in humans - Clinical Trial Exemption Scheme (CTX).

Conformity assessment fees

Conformity assessment fees are payable for Description of fees
Applying for:
  • a TGA Conformity Assessment Certificate
  • re-certification of a TGA Conformity Assessment Certificate when it is due to expire
Application fee is payable for lodging the application with the TGA

Assessment of the documentation supplied to demonstrate compliance with the Essential Principles, either for:

  • an initial application
  • a re-certification
  • TGA will conduct a preliminary assessment to determine the appropriate conformity assessment fee
  • An invoice will be raised and sent to the manufacturer for payment
  • Fees vary depending on the procedures the manufacturer has used
Surveillance audits of a manufacturer
  • The issue of a TGA Conformity Assessment Certificate may require an initial audit by the TGA
  • After this, audits will occur regularly - generally at least 18 months apart and no more than five years apart. Audits may be conducted more frequently if issues arise
  • In addition to the audit fee, reasonable travel, accommodation and allowance costs for travel both in and outside Australia are payable
Changes to a TGA Conformity Assessment Certificate Fees vary depending on the procedures the manufacturer has used and the extent of the change
Testing of medical devices by the TGA, if required for type examination for a kind of medical device under Schedule 3, Part 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. Direct and/or indirect costs of conducting the tests, including the cost of any consumables used to conduct the tests

Application audit (technical file review) fees

Some applications to include IVDs on the ARTG will automatically undergo an application audit. Fees apply for IVD applications automatically selected for an application audit.

Note: for IVD applications, an application audit will take the form of a technical file review.

Fee reductions

The therapeutic goods legislation:

  • allows exemption from annual charges for low value turnover products
  • allows audit and assessment fees to be reduced
  • has no provisions to reduce application fees.

Regulation 9.6 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) provides for a 70% reduction in assessment fees payable in relation to a medical device (including IVDs) if the supply of the device:

  1. is in the interest of public health, and
  2. would not be commercially viable for the manufacturer or sponsor if the full amount of the fee were paid.

Regulation 9.7 of the Regulations includes provisions for reduced fees for application audits and conformity assessments, where information is available that allows the assessment to be abridged. Relevant information must relate to the IVD or some or all aspects of the conformity assessment procedures applicable to the device.

The applicant may provide the TGA with the details of previous conformity assessment evidence or previous TGA registrations or current TGA licenses. The TGA may request copies of the documentation if the assessment was conducted by another conformity assessment body. This may allow the TGA to reduce the level of assessment and consequently the applicable conformity assessment fees. If the TGA determines that the information is sufficient for an abridged assessment to be conducted, the TGA will determine the appropriate reduced fee.

Application audit fees may be reduced if the evidence of conformity is applicable to several kinds of IVDs and the applications are submitted at the same time. This would usually apply to applications for Class 2 and 3 IVDs that have different collective terms. Normally application audit fees would be levied for each kind of IVD. The sponsor needs to apply to the TGA for a reduction in fees. For more information on the criteria and timeframes that must be met for a successful application to reduce the fees please refer to Section - Application audits.

By default, the TGA will undertake full assessment of an application at the full prescribed fee.

Payment of fees by instalments

In accordance with Regulation 9.5 of the Regulations, the TGA may approve an instalment payment plan where the assessment fees exceed $10,000 and the payment of the fee as a lump sum would result in financial hardship for the manufacturer or sponsor.

Instalment payment plans will be designed to ensure full payment is made prior to the finalisation of an assessment. Conditions, including interest, may be applied for an approved instalment plan. Payment plans that extend beyond the financial year will usually have interest imposed on the debt.

Sponsors must:

  • apply in writing for an instalment plan
  • include supporting information demonstrating financial hardship (financial statements, budget projections etc).

The usual instalment plan is:

  • 50% of the fee prior to commencement
  • 25% to be made 30 days later
  • the balance is payable on completion of the assessment/audit or withdrawal of the application by the applicant.

Failure to make an instalment payment by the agreed date will result in the balance of the amount being payable in full.

The TGA cannot consider a request for instalment payments while another fee or charge remains unpaid.

The TGA will advise the applicant in writing within 30 days if the decision to grant instalment payments is approved. Applicants are required to agree to the conditions relating to the instalment payment plan in writing.

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