TGA Updates Guideline on Reducing Medical Device Assessment Fees

Australia’s Therapeutic Goods Administration has updated the procedures for determining when fees can be reduced for audits and conformity assessments of medical devices.

Under the guidance, issued April 24, the TGA may reduce the fee by 70 percent if an applicant can show there is a public health need for the device or that it would not be commercially viable for the devicemaker to pay the full amount.

Application fees also may be lowered based on the amount of regulatory assessment already undertaken by the TGA or a recognized conformity assessment body, such as a European notified body, the agency says.

The revised guidance doesn’t include exact reduced fee amounts for the various circumstances that allow for a shortened conformity assessment, but rather describes scenarios for shortening the assessment and provides a description of how to determine the reduced fee.

Read the guidance, which replaces a 2011 version, at www.fdanews.com/4-15-TGA-Fees.pdf.
— Jonathon Shacat