Position Statements, Policies and Submissions

In addition to providing a range of services for its members, Pathology Technology Australia pursues a strategy of raising the awareness of the clinical and cost utility of diagnostics in the provision of effective healthcare across Australia.

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

To this end the Association is active in Government reviews and meetings with key Federal and State Ministers, regulatory agencies such as the TGA, DoH and DAWR, learned societies and groups such as AACB, AIMS, PA, PPA and RCPA, and other bodies such as Standards Australia and NATA.

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

Position Statements

IVD Australia Position Statements and Policies

Position Statement - Direct to Consumer Genetic Testing

Position Statement - Non-Medical Testing

Position statement - Vendor Credentialing
Pathology Technology Australia does not support the imposition of vendor credentialing programs unless the Standards Australia (SA) Vendor Credentialing Standard is adopted by HCFs. The SA Standard is available from SAI Global.

Pathology Technology Australia Advocacy Agenda

Use of Pathology Technology Australia Logo Policy

Trade Practices Act Disclaimer

Areas under development include:

Reimbursement of Pathology Testing
Point of Care and Near Patient Testing
Personalised Medicine and Pharmacogenomics



2016-17 Submissions

IVD Australia Submission to the 2017 - 2018 Federal Budget
IVD Australia Submission to the Therapeutic Goods Act Amendment 2016
IVD Australia Response to Draft AS-NZS 4760 - KEY ISSUES
IVD Australia Response to Draft AS-NZS 4760 - TABLE
IVD Australia Response - Designation of Australian Conformity Assessment Bodies for Medical Devices
IVD Australia - Accelerated Assessment of Medical Devices - Priority Review Pathway - Implementation
IVD Australia Response to the Advertising Consultation
2015-16 Submissions
IVD Australia Submission to MSAC Technical Guidelines Consultation
IVD Australia Submission to National Diabetes Consultation
IVD Australia Submission to Classification of IVDs to Detect Pathogens on NNDSS List
IVD Australia Submission to Changes to the URPTG
IVD Australia Submission to the Cancer Drugs Senate Inquiry
IVD Australia Submission to the Federal Budget
IVD Australia Response Proposed Performance Requirements and Risk Mitigation Strategies for HIV Tests
IVD Australia Submission to the Expert Review of Medicines & Medical Devices Regulation
2014 Submissions
Submission on "Self Testing for HIV"
MTAA and IVDA Joint Submission: Post-market Review of Products Used for Diabetes
Management – Stage Two of the Diabetes Review on Insulin Pumps
Low Value Low Turnover Submission

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

Powered by Wild Apricot Membership Software