Therapeutic Goods Amendment Bill 2016 March 2017

On 10 February 2017 MTAA received an invitation from the Community Affairs Legislation Committee to provide a written submission on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016.  The MTAA would like to thank the Community Affairs Legislation Committee for the opportunity to provide feedback on the proposed changes to the Therapeutic Goods Act 1989. The MTAA supports the overarching intentions of the proposed amendment to implement key recommendations of the Expert Panel Review of Medicines and Medical Devices Regulations relevant to medical devices (recommendations 15, 24 and 27), and streamline the structure of statutory advisory committees for medical devices. However, certain proposed changes outlined in the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, require further discussion and clarification as detailed in this submission.