Events

This information session introduces UDI for clinical quality registries. Australia’s UDI framework supports improved identification of medical devices and in vitro diagnostic (IVD) devices

The TGA hosted an information session to discuss the key issues identified in the consultation paper and outlined the proposed regulatory options to address these issues.

This session provided an overview of the public consultation on the proposed amendments to the conformity assessment procedures for medical devices.

This presentation provides a background on our digital transformation and a walkthrough of the Beta (demonstration) version of the new TGA business services portal.

Learn about the temporary risk-based strategies being introduced on 1 July 2025 to expedite the reduction of the Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) backlog.

The Australian UDI Database opened for sponsors to submit data 30 March 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presentations given by the TGA at the 2025 ARCS Annual Conference, 3-4 June 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

This presentation provides an overview of TGA’s Good Clinical Practice (GCP) Inspection Program clinical trial compliance activities.

This presentation provides information for external stakeholders about the proposed IVD regulation changes.

Are you interested in applying to be a member of one of the TGA’s Statutory Advisory Committees? Hear first-hand from current members and the Chief Medical Adviser about what this exciting role is like.

This is a Q&A session for industry about the recently published guidance on listed probiotic medicines.

An overview of the amended sponsor portal to include unapproved medical devices and provides guidance on how to apply for consent to import, supply or export medical devices that do not comply with the Essential Principles (EPs).

Guidance on completing updated notification form for new therapeutic vaping products, and information on the re-statement of compliance when requested by TGA.

See the upcoming changes in the PRAC – the new procedure document that will replace the Uniform Recalls Procedure for Therapeutic Goods (URPTG).

Presentations given by the TGA at the ARCS 2025 Regulatory Summit, 19 February 2025