Australia to revise device evaluation fees:
This article was originally published in Clinica
Executive Summary
A revised schedule of premarket evaluation fees is to be introduced by the Australian Therapeutic Devices Branch (TDB) during 1995. The fees will be established according to the level of equivalence to a previously evaluated and currently registered device. The greater the equivalence, the lower the fee, according to the Australian Therapeutic Device Bulletin. It will therefore be vital for companies to submit properly developed tables of equivalence in support of product applications, says the TDB. In the case of applications which are received concurrently and which are capable of simultaneous evaluation, the fee charged will be one-third of the normal fee in each category for each of the applications apart from the first.