Submissions

Submissions

Advertising

Mar 2019Follow-up Submission to TGA consultation #2: Proposed Therapeutic Goods Advertising Code Guidance
Nov 2018Follow-up Submission to TGA Consultation #1: Proposed Therapeutic Goods Advertising Code Guidance
Oct 2018TGA Advertising Code Guidance
Jun 2018Complaints handling DTC advertising
Apr 2018TGA Advertising Code and Associated Guidelines
Oct 2017TGA Advertising Code revision
Dec 2016Advertising for therapeutic goods regulation
  

Annual TGA Performance Stats

Apr 2019Proposed content for the annual TGA performance statistics report
  

ARTG Variations

Feb 2016Feedback to the TGA RegTech Consultative Forum
  

Clinical Evidence

Jun 2016Clinical evidence guidelines Medical devices
  

Cybersecurity

Feb 2019Medical device cyber security
  

NZ Therapeutic Products

Apr 2019NZ Therapeutic Products Regulatory Scheme
  

Personalised including 3D printed medical devices

Mar 2019Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Dec 2017Proposed regulatory changes related to personalised and 3D printed medical devices
Oct 20173D Printing Technology in the Medical Device Field – Australian Regulatory Considerations
  

Prosthesis List

Oct 2018Comparison of prostheses pricing across different markets
  

Regulatory Reform

Apr 2019Proposed changes to the classification of active implantable medical devices and their accessories
Mar 2019Proposed reclassification of spinal implantable medical devices
Mar 2019Regulation of software, including Software as a Medical Device (SaMD)
Jan 2018Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017
Aug 2017Alignment with European medical device regulatory framework – Up-classification of surgical mesh, Patient implant cards
Jun 2017Comparable overseas regulators – medical devices
May 2017Enhancing sanctions and penalties in the TG Act 1989
May 2017Options for the future regulation of “low risk” products
Mar 2017Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)
Mar 2017Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016
Dec 2016Designation of Australian Conformity Assessment Bodies for Medical Devices
Dec 2016Accelerated assessment of medical devices – Priority Review pathway
Sep 2015Medicines and Medical Devices Review Taskforce
  

Senate Inquiry

Jun 2018MTAA Position Paper to the Senate Report: Number of women in Australia who have had transvaginal mesh implants and related matters
Jan 2018The effect of red tape on health services
Feb 2017Senate Inquiry into the Prostheses List Framework
  

UDI

Feb 2019TGA consultation: Proposal to introduce a Unique Device Identification system for medical devices in Australia