Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled new guidance on the eligibility requirements for medical device and in vitro diagnostic (IVD) companies looking to reduce assessment fees by as much as 70%.
The reduction in fees could save industry a significant amount of money as, according to the new fees published in July by TGA, conformity and audit assessment fees can range from about $4000 to more than $50,000, depending on the type of assessment.
The fee reductions were first instituted under the Therapeutic Goods (Medical Devices) Regulations 2002, in certain cases:
- when the 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
- when TGA can abridge an assessment
Public Health Need
The new guideline from Monday offers additional information about the eligibility requirements and procedures used by 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.
For devices that a company believes are in the interest of public health and would not be commercially viable if the full amount of the fee were paid, device applicants must ensure that similar devices are not already available on the Australian market.
Device applicants also would have to provide to TGA details of likely sales figures and profit margins if companies decide to use this route and prove that there’s limited sales potential.
When information is already available on a device that allows a device’s assessment to be abridged, companies can also reduce their assessment fees from between 15% and 65%, depending on the type of assessments, TGA says. The amount of the reduction in these cases is commensurate with the level of assessment required to ensure regulatory compliance.
“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,” the guideline says.
TGA also includes other examples of when fees may be reduced for application audit assessments, and quality system and product certificate assessments.
Reduction of Assessment Fees for Medical Devices