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On 29 November 2023, the Point-of-care (POC) Manufacturing of Medical Devices - Dental Sector Working Group was established. This Working Group is an extension of the time-limited Personalised medical devices: Australian Dental Sector Working Group (DSWG).
The DSWG is no longer operational.
For membership and meeting statements visit the POC Manufacturing of Medical Devices Steering Committee and Working Groups page.
On 9 April 2021, seven (7) peak professional and industry bodies representing the dental and oral health sector participated in a workshop convened by the Therapeutic Goods Administration (TGA) to discuss the implementation of the new personalised medical devices framework. The new framework legislation and regulations are made and agreed by the Australian Government Minister and/or the Parliament. The TGA is responsible for publishing guidance on compliance with the legislation and regulations.
Participants agreed that there is a need for ongoing liaison between stakeholders representing the sector and the TGA, and expressed interest in formally establishing an Australian Dental Sector Working Group (the DSWG).
Feedback from the DSWG will assist the TGA and the sector to implement the new personalised medical devices framework, including identifying concerns and/or areas requiring additional communication and clarification (including in guidance material). The DSWG will also be an important mechanism to help inform the TGA on updates to the Minister, including about concerns identified and potential refinements to the framework (for consideration by the Minister, the Australian Government or Parliament as appropriate).
Purpose
- Assist with the development of resources and communications that will support the implementation of the personalised medical devices framework;
- Identify, discuss and provide feedback on components of the personalised medical devices framework that may require clarification and/or potential refinements. This would include those matters identified at the Stakeholder Workshop held on 9 April 2021;
- Provide information and support to relevant stakeholders through their networks; and
- Offer suggestions, feedback and input to the TGA’s communication and engagement activities and ongoing implementation, including activities and initiatives that are working well.
Meetings and communiques
DSWG meetings will be held on a bi-monthly (once every two months) basis via teleconference, with further teleconferences and face-to-face meetings arranged to address specific time-critical issues if required.
Following each meeting, a communique is published. DSWG members may also be requested to provide feedback on documents or other issues as they arise out of session. Where out of session input is requested, an overview of these requests and feedback received will be summarised and reported to the DSWG at each formal meeting.
Membership
The members of the DSWG will consist of two (2) representatives from the following organisations:
- Australian Dental Association (ADA)
- Australian Dental Industry Association (ADIA)
- Australian Dental and Oral Health Therapists Association (ADOHTA)
- Australian Dental Prosthetists Association (ADPA)
- Australian Society of Orthodontists (ASO)
- Dental Hygienists Association of Australia (DHAA)
- Dental Implant Registry (DIR)
The working group will also consist of two dental technicians, who have been nominated by the dental sector and agreed to by the TGA.
As required, the TGA may invite other guests who have specific knowledge or expertise to participate in the meeting discussions. The DSWG may be requested to assist in identifying the relevant invited guests.
Contact us
Australian Dental Sector Working Group
personaliseddevices@health.gov.au