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On 27 August 2021, the third meeting of the Australian Dental Sector Working Group occurred and continued its discussions around the implementation of the new regulatory framework for personalised medical devices.
Key discussion points included:
- Action items from previous meetings.
The outcomes of the public consultation on proposed refinements to the regulation of personalised medical devices, including a summary of the outcomes, and the newly commenced amendments:
- Therapeutic Goods (Medical Devices - Specified Articles) Amendment (Personalised Medical Devices) Instrument 2021
- Therapeutic Goods (Excluded Goods) Amendment (Personalised Medical Devices) Determination 2021.
(The Dental Sector Working Group and the TGA will collaborate on targeted guidance to address these changes.)
- The Therapeutic Goods Advertising Code (No. 2) 2018 requirements for advertising medical devices with a focus on personalised medical devices (from a dental sector-specific perspective) to consumers and health professionals.
- The need for guidance establishing clear boundaries between the intersection of regulation of clinical practice under Ahpra and the manufacturing of personalised medical devices as regulated by TGA.
Further information
Meeting statements are published after each meeting.
For further information on the Australian Dental Sector Working Group, please visit: Personalised medical devices: Dental Sector Working Group.