On 29 June 2021, the second 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:
- Work that had occurred since the previous meeting, including updated guidance published on the TGA website, webinars, meetings, requirements in relation to annual reporting for custom-made devices, and briefings provided to the Government.
- Ways for the TGA to improve its outreach to training and education institutions providing training in dental technology;
- The suitability of current Global Medical Device Nomenclature Terms for describing dental and orthodontic appliances supplied in Australia, noting that many Terms refer to 'custom-made' and that additional guidance would help sponsors to identify the most appropriate terms;
- The public consultation on proposed refinements to the regulation of personalised medical devices, which closes on 14 July and an overview of the next steps following the consultation period closing including analysis, publishing of the outcomes, preparation of advice for Government consideration and implementing the Government decisions; and
- The Therapeutic Goods Advertising Code (No. 2) 2018 and the need for specific guidance to assist in clarifying the requirements for advertising of personalised medical devices (from a dental sector-specific perspective) to consumers and health professionals, and how this interacts with other advertising requirements for dental health professionals administered through the Australian Health Practitioner Regulation Agency (Ahpra).
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