Events

Information session for external stakeholders about the proposed IVD regulation changes.

In this webinar we will provide an update on the Australian UDI implementation and discuss the challenges and benefits of having UDI in healthcare and the role of hospitals and other healthcare providers in relation to using UDI.

Guest speakers from Zebra Technologies will share observations and learnings from the UK Scan4Safety pilot.

Using UDIs in healthcare - real world experience.

UDI Webinar No. 8

UDI Webinar No. 7 - Global manufacturer UDI learnings.

General regulatory requirements of medical devices, what antiviral claims can be made and types of evidence required.

TGA presentation slides from International Society of Pharamacovigilance (ISoP) Annual Meeting 2021 – Post conference course III, NSW (18 November 2021).

UDI Webinar #6 – 2021 Wrap-up, questions, and answers.

TGA presentation slides from International Society of Pharmacovigilance Annual Meeting, Victoria (10 November 2021).

A presentation on the role of a UDI Issuing Agency, including project update and Q&A.

TGA presentation slides from NSW Active MedTech Webinar (8 September 2021).

A presentation and Q&A on UDI from a perspective of a global medical technology company.

Further considerations for the Australian UDI, including global alignment, GMDN and data elements.

TGA presentation slides from Queensland Cardiovascular Research Network Webinar (25 June 2021).

An introduction to the Australian Unique Device Identification system

EU Medical Device Regulation changes and the implications for the TGA and Australia

TGA presentation slides from Virtual Public-Private Dialogue (PPD) on Biotechnological products in partnership with Peru INS (11 May 2021).

Guidance for industry on the new regulatory framework for personalised medical devices commencing on 25 February 2021.