Would cost recovery be inconsistent with government policy objectives?
The administrative rules for cost recovery for IVDs will be the same as other medical devices. Sponsors will be required to submit fees at the time of application, although fees for conformity assessments will be notified following validation of the path of conformity and the scheduling of quality system audits. • Applications will be lodged via the TGA’s online electronic lodgment system which permits an invoice to be created at the time of processing. Companies may pay fees by cheque, credit card or via online payment systems; and • Fees for conformity assessment are payable prior to commencement of the assessment. Annual charges relating to the maintenance of an inclusion on the ARTG will be invoiced each year in July. Companies may pay the amount by cheque, credit card (up to $10k) or via online payment systems. The cost recovery arrangements are considered to be cost effective – they are simple, well understood by Sponsors, require payment at the time a service is to be performed,
