Consultation: Proposed changes to the IVD medical device classifications and definitions

Closes 23 May 2025

Opened 12 Mar 2025

Contact

IVDs@tga.gov.au

Overview

The Therapeutic Goods Administration (TGA) is seeking stakeholders’ feedback on proposed changes to the IVD medical device classifications and definitions.

This consultation aims to confirm views on aligning classification rules, principles, and definitions with the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR) where appropriate. The proposed changes include:

•            Australian classification rules and principles that classify IVD devices in proportion to the health risk posed by their intended purpose, technology, and use.

•            Adoption of certain terminology from the EU classification rules to enhance clarity and ensure the rules encompass new and emerging technologies.

•            Increased clarity on specific IVD terms currently not defined in the Australian Regulations.

 

This consultation does not address the Australian classification rule 1.4 for self-tests. The TGA plans to conduct a separate consultation to review the regulatory controls for IVD self-tests.

 

The consultation paper will be available for public comments from 12 March 2025 to 23 May 2025. Submissions in response to the consultation paper can be made through the online survey link below during this time period.

You can right click on the consultation paper below and open a new tab to access the paper while going through the online survey.

For any questions relating to this consultation, please email us at IVDs@tga.gov.au.

Give us your views

Online Survey

Events

  • Webinar

    From 8 May 2025 at 12:30 to 8 May 2025 at 13:30

    This webinar will be held to provide an overview of the consultation and opportunity for stakeholders to ask questions on the consultation. For more information, please visit the link below.

    Add to my Calendar (.ics)

Audiences

  • Aboriginal and Torres Strait Islander People
  • Seniors
  • Men
  • Women
  • Carers and guardians
  • Families
  • Parents
  • Young people
  • Academics
  • Consumers
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Health professionals
  • Health workforce
  • General public
  • Community groups
  • Businesses
  • Industry
  • Sponsors
  • Manufacturers
  • Sponsor
  • Manufacturer
  • Consumer/Public
  • Health professional
  • Advertisers
  • Medical Devices & IVDs

Interests

  • Health technology
  • Legislation
  • Regulatory policy