In response to stakeholder feedback received during the implementation of the Personalised Medical Devices Framework (the Framework), the TGA is focusing on how the new Framework applies to manufacturing at the point-of-care and what refinements could be made to ensure regulation is appropriate without introducing unnecessary burden for point-of-care facilities.
Four surveys, which closed on 17 May 2023, were conducted to obtain more information about point of care manufacturing activities in four sectors from the following cohorts:
- Allied health sector
- Dental sector
- Manufacturing hubs at the point-of-care
- Hospital and healthcare facilities where medical devices are manufactured at the point-of-care
The paper provides an analysis of the survey results from the four surveys. It includes:
- a snapshot of response numbers
- brief insight into the demographic of respondents
- information relating to the adaptation, design, manufacture, and supply of medical devices
- identification of emerging themes and issues.
Contents
- Overview
- Allied health sector
- Dental health sector
- Manufacturing hubs
- Hospitals and health care facilities - for policy/governance teams