With an eye toward ensuring consistency and transparency, Australia’s Therapeutic Goods Administration has unveiled guidelines explaining how medical device and in vitro diagnostic companies can save up to 70 percent on assessment fees.
Specifically, the guidelines offer additional information about the requirements and procedures used by the TGA to determine if fees can be lowered for application audit and conformity assessments. To that end, applicants must clearly demonstrate that the supply of the device is crucial to ensuring public health. If similar devices are already available on the Australian market, it is unlikely the fees would be reduced, the TGA says.
According to the regulator, the guidance is needed to help TGA staff determine if an abridged assessment and reduction of fees is appropriate. In addition, it will help make the fee assessment process more transparent and consistent for applicants.
The requirements are only likely to be met for devices of low value and limited sales potential. Applicants would need to provide details of potential sales figures and profit margins for the agency to consider the commercial viability of supplying the device, according to the guidance.
The new guidance doesn’t detail exact reduced fee amounts, but rather describes scenarios for shortening the assessment and provides a description of how to determine the reduced fee.
The regulations include provisions for reducing fees for application audit assessments and conformity assessments, if information is available that allows the assessment to be shortened, the TGA says.
“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 recognized conformity assessment body (e.g. European Notified Body), if sufficient evidence is available that allows the TGA to abridge the assessment,” says the guidance.