Point-of-care Manufacturing of Medical Devices Steering Committee, Meeting statement, Meeting 2, 5 March 2024

The Point-of-care (POC) Manufacturing of Medical Devices Steering Committee met on 5 March 2024 via videoconference.

Key discussion points included: 

• Agreement to the Steering Committee and the sector specific Working Groups Terms of Reference and publishing on the TGA’s website.
• Agreement to the process of ensuring the consumer voice is considered in the Steering Committee and sector specific Working Group’s deliberations via the Medical Devices Consumer Working Group.
• Consideration of the professional standards for engineers in Australia and information specific to the biomedical engineering discipline.
• The current governance structures (in both federal and state jurisdictions) of relevant regulators and statutory bodies which affect and influence the regulatory requirements and/or oversight mechanisms of point-of-care manufacturing of medical devices in Australia.
• A process for considering potential refinements to the current regulatory framework for medical devices manufactured at the point-of-care.
• The publication by the TGA of its guidance resources and the development of additional education materials through various media.

Further information

For meeting statements and information on the Point-of-care Manufacturing of Medical Devices Steering Committee, visit POC Manufacturing of Medical Devices Steering Committee and Working Groups