Posted by Michael Wonder on 26 Oct 2017
Strengthening the assessment of medical devices and information for consumers
26 October 2017 - A new regulatory framework for surgical mesh devices and provision of information to the consumers for all implantable medical devices was approved by the Minister for Health, the Hon Greg Hunt.
The changes are intended to maintain the alignment of the Australian regulatory framework with similar initiatives recently announced in Europe.
They are another step in the implementation of the broader regulatory reform agenda set by the Review of the Medicines and Medical Devices Regulations. In particular, the Government has accepted recommendation 20 of the Review which states that the regulation of medical devices by the TGA is, whenever possible, aligned with the European Union framework.
