Reduction of assessment fees for medical devices

Guidelines for reducing assessment fees for ARTG application audits and conformity assessments of medical devices (including IVDs)

30 November 2015

Book pagination

TGA guidance for reduction of medical device assessment fees

Guidance about reduction of assessment fees for medical devices (including IVDs) has been developed with the aim of:

  • Simplifying the guidance used by TGA staff to determine if an abridged assessment and reduction of assessment fees is possible and appropriate.
  • Making the TGA process of determining the level of reduced assessment fees for medical devices more consistent and transparent to applicants.

The guidance does not prescribe exact reduced assessment fee amounts for different circumstances that allow for an abridged conformity assessment. Instead, it describes scenarios where an abridged assessment may be possible and provides a description of how a reduced assessment fee may be determined by the TGA financial delegate.

The document also incorporates guidance on the reduction of assessment fees for application audits of medical devices (including IVDs), as this is done under the same regulation as that for reducing conformity assessment fees.

Version history

Version Description of change Author Effective date
V1.0 First version of this document. Combined elements of previous internal TGA business rules. Office of Devices Authorisation 06/10/2011
V1.1 Minor amendments for consistency, including clarification that the document does not relate to IVD medical devices. Office of Devices Authorisation 21/11/2011

References to Department of Health and Ageing updated to Department of Health

References to Office of Devices Authorisation updated to Devices Authorisation Branch

Various edits to improve clarity including addition of document numbering, addition of information box in Section 3.1.1 and other textual edits.

Correction to Table 1.2 to remove "recertification" and to add "where new certificates are required for previous conformity assessment certificates that are expiring" under Item 1.9.

Fractional fees updated to percentages in Section 3.3

Devices Authorisation Branch 22/04/2015

Updated to include IVD medical devices

References to Devices Authorisation Branch updated to Medical Devices Branch

Reference to Monitoring and Compliance Branch in Section 1 removed

Medical Devices Branch 24/11/2015

Book pagination