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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.