IVD Australia



Submissions and Reviews

Advocacy on behalf of the IVD industry is a major part of the activities undertaken by IVD Australia as it seeks to influence policy regarding the importation, regulation, reimbursement and market access for in vitro diagnostics.

To this end IVD Australia is active in Government reviews and in regular meetings with key Federal Ministers and the Opposition, regulatory agencies such as the TGA and AQIS, learned societies and groups such as RCPA, AACB, ASM and AIMS and other bodies such as AAPP, PPA, Standards Australia and NATA.

Consultations and Submissions are a key means of communicating the IVD industry's position on these important matters.


2016-17 Submissions


2015-16 Submissions


2014 Submissions

2013 Submissions

  • "Submission on "Changes to premarket assessment for medical devices"
  • Submission on "Description of a possible joint regulatory scheme for therapeutic products under Australian and New Zealand Therapeutic Products Agency (ANZTPA)"
  • Submission on "Draft Report of Stage 1 of the Review focusing on Blood Glucose Test Strips"

2012 Submissions

  • Submission on "Proposed Fees and Charges''
  • Submission on "Review of Products and Medicines Used in the Management of Diabetes"
  • Submission on "MSAC Protocol Survey"

2011 Submissions

  • Submission on "Regulatory Standards for the Approval of Medical Devices''
  • Submission on "Review of the Funding Arrangements for Pathology Services"
  • Submission on "Panel to Review the Transparency of the Therapeutic Goods Administration"
  • Submission on "Proposal for changes to MSAC Processes for Application for Public Funding"
  • Submission on "Patent Amendment (Human Genes & Biological Materials) Bill 2010"

2010 Submissions

  • Submission on "Reforms in the Medical Devices Regulatory Framework"
  • Submission on "Consultation Draft on Assessing a Pair of Co-Dependent Technologies"
  • Submission on "Consultation Paper on Advertising of Therapeutic Goods"
  • Submission on "Position Paper on the Promotion of Therapeutic Goods"
  • Submission to "Review of Pathology Funding Arrangements"
  • TGO on "Standard for minimising infectious disease transmission"

2009 Submissions

  • Submission on Standards for Heparin