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Reduction of assessment fees for medical devices

Version 3.0, November 2015

30 November 2015

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1. Overview

The TGA is fully cost-recovered and collects its revenue primarily through annual charges, application fees, and assessment fees.

The Therapeutic Goods (Medical Devices) Regulations 2002, the Regulations, prescribes certain circumstances where assessment fees for medical devices may be reduced, including:

  • reduction in assessment fees where supply of a medical device is in the interests of public health, and it would not be commercially viable if the full amount of the fee were paid (regulation 9.6); and
  • reduction in assessment fees where the Secretary has information about the medical device, or the conformity assessment procedures that have been applied to the medical device, that allows the assessment to be abridged (regulation 9.7).

Information about the fees and charges for medical devices can be found in Section 2 of the Australian Regulatory Guidelines for Medical Devices (ARGMD) available on the TGA website.

This guideline provides additional information about the eligibility requirements and procedures used by the TGA in order to determine whether assessment fees administered by the Medical Devices Branch can be reduced for application audit assessments and conformity assessments involving medical devices (including IVDs).

This document has been updated to cover IVD medical devices and replaces the previously published guideline entitled Business rules for reduced assessment fees for IVDs.

1.1 Scheduled fees

Schedule 5 of the Regulations specifies the various fees that apply to medical devices, including; application fees, notification fees, and assessment (or evaluation) fees.

By default, the full scheduled fee applies to all applications, notifications and assessments for medical devices and the applicant should always be prepared to pay the full amount. There is no legislated obligation for the Secretary to reduce any fees; however, the Secretary does have the discretion to reduce fees in some circumstances.

The fees prescribed in Schedule 5 of the Regulations are subject to annual adjustment.

The fees and charges currently applicable to medical devices are available on the TGA website.

1.1.1 Application fees

A summary of the legislative references for relevant scheduled application fees for conformity assessment applications, and applications to include medical devices in the Australian Register of Therapeutic Goods (ARTG), are provided in the table below.

Please note:

  • An application fee is payable in order for an application to become effective, and allow the TGA to perform an assessment (if required)
  • If the TGA is required to undertake an assessment in relation to the application, further assessment fees will apply in addition to the application fee.
  • There is no legislative provision for the reduction of application fees.
Table 1.1 Legislative references for medical device application fees
Type of Application Scheduled Fee Reference

Application to include medical device in the ARTG

Different application fees apply to different classes of medical devices.

Schedule 5, Part 1, Item 1.5

Application for conformity assessment certificate

Applicable to applications for new certificates or changes to certificates.

Schedule 5, Part 1, Item 1.1

1.1.2 Assessment fees

A summary of the legislative references for relevant scheduled assessment fees for application audits and conformity assessments are provided in the table below.

Table 1.2 Legislative references for medical device assessment fees
Type of Assessment Scheduled Fee Reference
Application audit assessment - Level 1 Schedule 5, Part 1, Item 1.13
Application audit assessment - Level 2 Schedule 5, Part 1, Item 1.14
Application audit assessment for Class 1, Class 2 and Class 3 IVD medical devices Schedule 5, Part 1, Item 1.14A

Conformity assessment - initial assessment

Applicable to applications for new QMS certificates or new design or type examination certificates, including where new certificates are required for previous conformity assessment certificates that are expiring or have expired.

Schedule 5, Part 1, Item 1.9 (non-IVD medical devices)

Schedule 5, Part 1, Item 1.9A (IVD medical devices)

Conformity assessment - assessment of changes

Applicable to current conformity assessment certificates where a change to the device or QMS is required to be assessed.

Schedule 5, Part 1, Item 1.10 (non-IVD medical devices)

Schedule 5, Part 1, Item 1.10A (IVD medical devices)

Conformity assessment - Review of QMS certificate

Applicable to surveillance inspections, or any other review to determine whether the conformity assessment procedures have been applied to the kinds of devices covered by the certificate, for current Schedule 3, Part 1, 4 or 5 certificates.

Schedule 5, Part 1, Item 1.2

Conformity assessment - Review of product certificate

Applicable to a review of current Design Exam (Schedule 3, clause 1.6) or Type Exam (Schedule 3, Part 2) certificates, in relation to certification of compliance with the essential principles.

Schedule 5, Part 1, Item 1.3 (non-IVD medical devices)

Schedule 5, Part 1, Item 1.3A (IVD medical devices)

1.2 Reduction of assessment fees

Assessment fees for medical devices may be reduced by the Secretary (or their Delegate) under certain circumstances, as provided for under regulation 9.6 and 9.7 of the Regulations.

Regulation 9.6 of the medical devices Regulations states that:

9.6 Reduction of assessment fees

The Secretary may reduce by 70% the amount of an assessment fee specified in Schedule 5 in relation to a medical device if the supply of the medical device:

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

In order for regulation 9.6 to apply, the applicant must be able to clearly demonstrate that the supply of the medical device is in the interests of public health (as opposed to an individual's health, or the commercial interests of the company). If other similar devices are already available on the Australian market, it is unlikely that assessment fees would be reduced under this Regulation.

In order for the Secretary to consider the commercial viability of supplying the device, the applicant would be required to provide details of likely sales figures and profit margins. This regulatory requirement is only likely to be met for devices of low value and limited sales potential.

Note that both conditions, a. and b., must be met in order for Regulation 9.6 to apply.

The level of fee reduction under Regulation 9.6 is fixed at 70%, and applies only to assessment fees.

Regulation 9.7 of the medical devices Regulations states that:

9.7 Reduction of assessment fees - abridged assessment

  1. This regulation applies to an assessment fee specified in Part 1 of Schedule 5 in relation to any of the following:
    1. items 1.2, 1.3 and 1.3A (review of conformity assessment certificate);
    2. items 1.9 and 1.9A (initial assessment under conformity assessment procedures);
    3. item 1.10 (assessment consequent on a change to:
      1. a medical device; or
      2. the quality management system applying to a medical device);
    4. item 1.10A (assessment consequent on a change to:
      1. an IVD medical device; or
      2. the quality management system applying to an IVD medical device);
    5. items 1.13, 1.14 and 1.14A (application subject to audit assessment);
    6. item 1.16 (intermediate stage assessment or verification procedures).
  2. The Secretary may reduce the amount of the assessment fee if the Secretary has information that allows the assessment to be abridged, being information about:
    1. the medical device to which the fee relates; or
    2. some or all aspects of whether the conformity assessment procedures have been applied to the medical device.

Regulation 9.7 of the medical device Regulations includes provisions for reduction of assessment fees for application audit assessments and conformity assessments, where information is available that allows the assessment to be abridged.

The type of information that can be considered must relate either to the medical device, or to aspects of the conformity assessment procedures that have been applied to the medical device.

It may be possible for the TGA to lower the assessment fee according to the degree of regulatory assessment already undertaken, either by the TGA, or by a recognised conformity assessment body (e.g. European Notified Body), if sufficient evidence is available that allows the TGA to abridge the assessment.

The amount of any fee reduction under regulation 9.7 will be commensurate with the level of assessment required to ensure regulatory compliance, and applies only to assessment fees.

1.3 Important notes

9.7 Reduction of assessment fees - abridged assessment

  • There is no provision in the legislation to consider reduction of application fees, or other assessment fees such as:
    • Supplementary assessment fees under Schedule 5, Part 2.1 for travel costs and preparation time associated with on-site audits,
    • Supplementary assessment fees under Schedule 5, Part 2.2 for the cost of testing devices, for example as part of a Part 2 Type Examination assessment,
    • Assessment fees under Schedule 5, Part 1, Item 1.11 for an assessment of the data relating to a medicinal component of the device.
  • The Delegate of the Secretary under regulation 9.6 or regulation 9.7 is responsible for determining whether to reduce an assessment fee, and if so, the amount of the reduction.
  • The Delegate of the Secretary is not obliged to reduce an assessment fee.
  • Applicants cannot assume that assessment fees will be reduced for a particular application, and should be prepared to pay the full scheduled assessment fee if required.
  • In considering whether to reduce an assessment fee, the Delegate to the Secretary is not making an 'initial decision' under the Act. As such, the amount of the reduction, or the fact that an assessment fee has not been reduced, is not subject to review under section 60 of the Act.
  • Any reduced fees under $10,000 are rounded to the nearest $10 value, and any reduced fees over $10,000 are rounded to the nearest $100 value.

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