Point-of-care manufacturing of medical devices
Information and guidance about the regulation of point-of-care manufacturing of medical devices.
Healthcare facilities in Australia are developing point-of-care (POC) manufacturing capabilities using methods such as 3D printing to produce a wide variety of medical devices. POC manufacturing regulations apply to those people (eg: healthcare professionals) manufacturing these medical devices, in both public and private settings.
POC manufacturing often takes place:
- in facilities regulated by entities other than the Therapeutic Goods Administration (TGA)
- by people who manufacture devices as a component of clinical practice
These manufacturing processes are often different to traditional medical device manufacturing practices and the current framework for medical device regulation may not always be appropriate.
The recent introduction of new requirements for personalised medical devices has highlighted the scale and scope of POC manufacturing, and the need to review the current regulations.
A review of current regulations is underway to determine whether refinements are needed to protect patient health and safety, contribute to positive patient outcomes, and support the introduction of innovative technologies that seek to improve manufacturing at the POC.
To commence the information gathering for the review of the current regulations, we recently conducted four (4) surveys targeting specific sectors where POC manufacturing takes place:
- The allied health sector
- The dental sector
- Manufacturing hubs within hospitals
- Policy and governance teams within hospitals that have a manufacturing hub.
For an overview of the survey results see our publication Medical devices manufactured at the POC – Analysis of survey responses by sector.
National Symposium on POC manufacturing of medical devices
On 19 June 2023, we convened a National Symposium to present the results of the four surveys and to discuss issues associated with POC manufacturing as identified by survey respondents and gaps in regulation.
Attendees included nominated representatives and observers from:
- Australian Health Practitioner Regulation Agency (Ahpra) and its National Boards
- National Alliance of Self Regulating Health Professions (NASRHP)
- National Disability Insurance Agency (NDIA)
- The Australian Commission on Safety and Quality in Healthcare (ACSQHC)
- The Aged Care Quality and Safety Commission (ACQSC)
- State and territory government health department.
For a summary of the meeting and agreed outcomes, see our National Symposium on Point-of-care Manufacturing of medical devices page.
Keep up to date
Please contact us at email@example.com should you have any queries or comments.
You can also send an email to firstname.lastname@example.org with ‘SUBSCRIBE PMD’ in the subject line to receive:
- notifications when guidance documents and other information resources are published
- updates about the new framework
- details about webinars and workshops.
- GuidanceInformation for manufacturers to assist them with addressing risks and meeting the Australian regulatory requirements for medical devices
- Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devicesPublicationsRegulation Impact Statement in support of proposed reforms around personalised medical devices