Australia Personalised Medical Device Update
The Therapeutic Goods Administration (TGA) made acknowledgement to those who gave a response for its public consultation on “Proposed regulatory scheme for personalized medical devices, including 3D-printed devices”. on 2nd December 2019. Following earlier public consultations and forums in 2017 and 2018, the intention of this consultation was to understand the potential effect that the proposed amendments may exert on the medical devices industry, health care professionals, patients and healthcare system. The consultation feedback paper consists of six questions; any perceived advantages, disadvantages, unintended consequences, comments, suggestions, anticipated financial implications and estimated time periods that might be required to effectively implement the proposed new arrangements, if agreed by the Government.