Submissions

Submissions

This page includes all submissions produced by MTAA.

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
  

AI - Artificial Intelligence

Oct 2024Safe and Responsible Artificial Intelligence in Health Care – Legislation and Regulation Review
Oct 2024TGA Consultation: Clarifying and Strengthening the Regulation of Artificial Intelligence (AI)
Oct 2024Safe and Responsible AI in Australia | Proposals Paper for Introducing Mandatory Guardrails for AI in High-Risk Settings
  

Annual TGA Performance Stats

Apr 2019Proposed content for the annual TGA performance statistics report
  

ARTG Variations

Feb 2016Feedback to the TGA RegTech Consultative Forum
  

Budget

Jan 2024Pre-Budget Submission 2023/24
April 2022Pre-Budget Submission 2022/23
Jan 2021Pre-Budget Submission 2021/22
Aug 2020Pre-Budget Submission 2020
  

Clinical Evidence

Jun 2016Clinical evidence guidelines Medical devices
  

Clinical Quality Registries

February 2020Response to National Clinical Registry Strategy Consultation
  

Digital Health

Oct 2024Safe and Responsible Artificial Intelligence in Health Care – Legislation and Regulation Review
Oct 2024TGA Consultation: Clarifying and Strengthening the Regulation of Artificial Intelligence (AI)
Oct 2024Safe and Responsible AI in Australia | Proposals Paper for Introducing Mandatory Guardrails for AI in High-Risk Settings
August 2023Supporting Responsible AI (joint paper with APACMed)
May 2023Digital Health: Breaking Barriers to Deliver Better Patient Outcomes
Feb 2019Medical device cyber security
  

House of Representatives Inquiry

Nov 2020MTAA Submission to the Inquiry into approval processes for new drugs and novel medical technologies in Australia
  
 

National Reconstruction Fund

Feb 2023MTAA Submission Paper to National Reconstruction Fund
 

NZ Therapeutic Products

Apr 2019NZ Therapeutic Products Regulatory Scheme
  

Personalised Medical Devices

July 2021Proposed Refinements to the Regulation of Personalised Medical Devices
July 2019MTAA comments to the IMDRF consultation on regulatory pathways for personalized 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
  

Privacy

Mar 2023Privacy Act Review Report
  

Productivity Commission

April 2022Response to the Productivity Commission Inquiry into Productivity
  

Prosthesis List

Sep 2021Prostheses List Consultation: Definition, Purpose and Scope
Feb 2021Options for Reforms and Improvements to the Prostheses List
Mar 2020General Miscellaneous Review MTAA Submission to the Department of Health
Oct 2018Comparison of prostheses pricing across different markets
  

Regulatory Reform

Apr 2021MTAA’s submission to the Deregulation Taskforce
Nov 2020Proposed enhancements to adverse event reporting or medical devices
May 2020Scope of regulated software-based products
Oct 2019Proposed changes to the medical device Essential Principles for safety and performance
Sep 2019Surgical Implantation of Medical Mesh in South Australia
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

Oct 2024Senate Inquiry into the Whole Investor test
May 2020MTAA submission to the Senate Select Committee on COVID-19
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

Nov 2020Exploring options for the introduction of an Australian Unique Device Identification (UDI) System
Feb 2019TGA consultation: Proposal to introduce a Unique Device Identification system for medical devices in Australia