You are here
Reduction of assessment fees for medical devices
Version 3.0, November 2015
2. ARTG application audits
The Act and the Regulations (under paragraph 41FH(1)(a) and regulation 5.3 respectively) specify that certain applications to include devices in the ARTG must be selected for audit (compulsory audits). An audit assessment fee is payable for each application that the legislation requires to be selected for auditing. The TGA may also decide to select certain applications for audit (non-compulsory audits). Assessment fees are not payable for application audits where the TGA has decided to select an application for audit.
Depending on the application and the kind of device, the level of audit assessment will be determined. There are different fees for Level 1 and Level 2 application audits and IVD application audits, as specified under Items 1.13, 1.14 and 1.14A of Schedule 5 of the Regulations. The specified audit fees can be reduced under Regulation 9.7 where assessment can be abridged; for example, when a sponsor submits more than one application for inclusion of similar devices that can be grouped together for the purposes of assessment.
The following scenario is an example showing how fees may be reduced for application audit assessments:
- A sponsor submits multiple effective applications for device ARTG inclusion.
- All the effective applications for inclusion are received on the same day (that is, the application fees are paid on the same day);
- The applications are subject to compulsory audit as per paragraph 41FH(1)(a) of the Act and regulation 5.3 of the Regulations;
- All the applications are for the same medical device classification and are covered under the scope of the same Full Quality Assurance certificate (same Manufacturer’s Evidence);
- A written request from the sponsor for reduced fees is electronically attached to each of the applications and includes:
- A reference to each of the relevant application ID numbers to be considered for abridged assessment fees; and
- An explanation on why and how the assessment can be abridged (i.e. information required for the audit assessment is sufficiently common for all applications to allow an abridgment of the assessment).
The delegate of the Secretary for the purposes of regulation 9.7 considers the request for fee reduction along with the other submitted information. If the delegate decides that there is sufficient information to allow abridgment of some of the assessment, then the audit assessment fees can be reduced, and in this case:
- A full scheduled audit assessment fee will be charged for the audit of one of the applications; and
- A reduced audit assessment fee (generally equivalent to 28% of the scheduled fee) will be charged for each of the other applications in the same group.
- An invoice will be issued by the TGA for the amount of the audit assessment fees approved by the delegate.
There may be other scenarios where the delegate would determine that adequate information was available to allow an application audit assessment to be abridged, and the corresponding fees to be reduced. Requests for such fee reductions are considered on a case by case basis.
- Any reduction of assessment fees remains at the discretion of the Delegate of the Secretary for the purposes of regulation 9.7.
- The amount of any reduced assessment fees is not negotiable.
- Once the assessment fees have been invoiced, the fees are due and payable according to the instructions on the invoice.
- The decision to reduce the audit assessment fees is not subject to review under section 60 of the Act.