Posted by Michael Wonder on 19 Feb 2020
Medical device application processing times
19 February 2020 - Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review of Medicines and Medical Devices Regulation (MMDR).
The Government accepted MMDR recommendation 21 to 'establish target timeframes that reflect international benchmarks and the typical lifecycle of a medical device' for assessment and inclusion in the ARTG.
An independent reviewer was engaged to undertake consultation and examine how the TGA's process and timeframes compare with international regulators.
