Comments outside of the of proposal 2- Cancer Voices Australia: (1) Support the idea of all models and variations of a device be registered to ensure safety of use and to remove confusion as to what exactly is registered and what is not. (Proposal 3 Product name); (2) Strongly support more product information being – required to be published on the TGA website. (Proposal 4) Attachment E: Previous and current reform proposals The following maps the reform proposals in the 2010 and 2013 consultation processes, illustrating how these proposed reforms have developed over this period. TGA Blueprint October 2010 January 2013 Implementation Plan July May 2013 RIS Exposure Draft Notes Consultation Paper Consultation 2012* Proposal 1 Agreed Done replacement – implants were reclassified Reclassification of joint from 1 July 2012. replacement implants Proposal 2A The TGA will further develop Proposal C Abolition of Option 2 - Proposal C - – these proposals in consultation requirement for TGA Abolition of requirement for Use of third party assessment with stakeholders and provide conformity assessment for TGA conformity assessment for bodies for all Australian advice to Government. Australian manufacturers of Australian manufacturers medical device manufacturers lower risk medical devices (applies to all classes of (limited application to Class IIb devices, as originally proposed and lower) in 2010 proposal) Proposal 2B The TGA will further develop these proposals in consultation Increasing pre market scrutiny with stakeholders and provide for implantable medical advice to Government. devices
Comments outside of the of proposal 2- Cancer Voices Australia: (1) Support the idea of all models and variations of a device be registered to ensure safety of use and to remove confusion as to what exactly is registered and what is not. (Proposal 3 – Product name); (2) Strongly support more product information being required to be published on the TGA website. (Proposal 4) Attachment E: Previous and current reform proposals The following maps the reform proposals in the 2010 and 2013 consultation processes, illustrating how these proposed reforms have developed over this period. October 2010 Consultation Paper TGA Blueprint Implementation Plan July 2012* January 2013 Consultation May 2013 RIS Exposure Draft Notes Proposal 1 Reclassification of joint replacement implants Agreed Done – replacement implants were reclassified from 1 July 2012. Proposal 2A Use of third party assessment bodies for all Australian medical device manufacturers The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government. Proposal C – Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower risk medical devices (limited application to Class IIb and lower) Option 2 - Proposal C - Abolition of requirement for TGA conformity assessment for Australian manufacturers (applies to all classes of devices, as originally proposed in 2010 proposal) Proposal 2B Increasing pre market scrutiny for implantable medical devices The TGA will further develop these proposals in consultation with stakeholders and provide advice to Government.