Point-of-care Manufacturing of Medical Devices Allied Health Sector Working Group Meeting Statement, Meeting 1, 27 November 2023

The Point-of-care (POC) Manufacturing of Medical Devices Allied Health Sector Working Group met for the first time on 27 November 2023 via videoconference.

Key discussion points included: 

• The introduction of the personalised medical devices framework and the implications for the allied health sector.
• The commencement of the point-of-care manufacturing work and convening a National Symposium attended by state/territory government health departments and federal regulators.
• The role and purpose of the newly established POC Manufacturing of Medical Devices Steering Committee and the importance of maintaining active channels of communication to facilitate the timely sharing of information between the Steering Committee and the Allied Health Sector Working Group.
• The importance of leveraging the collective experience of Working Group participants and feedback from their members to ensure any potential options/solutions put forward by the Steering Committee are fit-for-purpose, focus on patient safety and do not introduce any unnecessary regulatory burden.
• Clarification on the regulation of externally applied orthopaedic medical devices and the increasing use of software in their manufacture.
• Agreement that cross-agency collaboration between regulators is needed to ensure information is communicated and handled effectively, for example to comprehensively review complaints that related to clinicians manufacturing medical devices. 

More information

Meeting statements and information on the Point-of-care Manufacturing of Medical Devices Allied Health Sector Working Group, visit POC Manufacturing of Medical Devices Steering Committee and Working Groups.