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Medical devices reforms: Consumer Working Group

14 April 2022
Additional information on medical device consumer working groups

Medical devices reforms: Consumer Working Group meeting statement, Meeting 4, 27 November 2020

17 February 2021
Agenda

The working group met via teleconference on 27 November 2020 to discuss:

Action Area 3 of the priorities agreed by the working group at their meeting on 19 November 2019; Benefits realisation Consumer fact sheet for personalised medical devices; The Reforms website; and The Action...

Medical devices reforms: Consumer Working Group meeting statement, Meeting 3, 18 June 2020

17 February 2021
Agenda

The working group met via teleconference on 18 June 2020 to discuss:

Action Areas 1 and 8 of the priorities agreed by the working group at their meeting on 19 November 2019; and The Action Plan for Medical Devices Report Card. Key points

Key points discussed at the meeting...

Medical devices reforms: Consumer Working Group meeting statement, Meeting 2, 20 February 2020

17 February 2021
Agenda

The working group met via teleconference on 20 February 2020 to finalise the terms of reference for the group and discuss Action Areas 2 and 5 of the priorities agreed by the working group at their meeting on 19 November 2019.

Key points

The majority of members were unable to...

Medical devices reforms: Consumer Working Group meeting statement, Meeting 1, 19 November 2019

17 February 2021
Agenda

Over 40 consumer representative groups were invited to participate in a workshop convened by the Therapeutic Goods Administration (TGA) on 20 August 2019 to discuss strategies and action items detailed in An Action Plan for Medical Devices .

Following the workshop, a number of the...

Webinar presentation: Personalised Medical Devices Framework

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

Emergency COVID-19 exemptions end for ventilators and personal protective equipment

29 January 2021
Two emergency exemptions that were made to facilitate the supply of ventilators and personal protective equipment in Australia during the COVID-19 emergency will cease on 31 January 2021

Advice for health procurement teams about therapeutic goods and medical devices

12 March 2021
Guidance for procurement areas in hospitals, aged care residential facilities and other facilities

Is my software regulated?

27 July 2021
The purpose of this document is to guide developers and users of software to decide which software and apps are medical devices

Examples of regulated and unregulated software (excluded) software based medical devices

11 October 2021
Guidance presenting examples that illustrate the boundaries between regulated and unregulated software.

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