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Point-of-care manufacturing of medical devices
Work is ongoing to review medical device regulations for point-of-care (POC) manufacturing.
Project overview
Healthcare facilities in Australia are developing point-of-care (POC) manufacturing capabilities using methods such as 3D printing. These capabilities produce a wide variety of medical devices.
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 framework for medical device regulation may not always be appropriate.
Regulatory changes in 2021 for personalised medical devices highlighted the scale and scope of POC manufacturing. There is a need to further review current regulations. We aim to determine whether refinements are needed to protect patient health and safety, contribute to positive patient outcomes, and support the introduction of innovative technologies.
Note:
Medical devices manufactured at the POC are currently regulated the same as devices manufactured in other settings. How a device is regulated depends on the type of device it is. Often, POC manufacturing produces patient-matched medical devices.
Personalised medical devices
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SectionA medical device can be any instrument, product or software (including AI) that works to achieve a therapeutic purpose in a human being.
Consultation
To start gathering information for the review of current regulations, we 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 Medical devices manufactured at the POC – Analysis of survey responses by sector.
National symposium on POC manufacturing of medical devices
In June 2023, we convened a National Symposium. We presented the survey results and discussed these.
Attendees included nominated representatives and observers from:
- TGA
- 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 departments.
For a summary of the meeting and agreed outcomes, see National Symposium on Point-of-care Manufacturing of medical devices.
National Symposium participants agreed the TGA, in collaboration with other regulators and state and territory governments, would establish a steering committee, and sector-specific working groups.
Point-of-care Manufacturing of Medical Devices Steering Committee and sector-specific Working Groups
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CommitteeInformation on the role and membership of the POC Manufacturing of Medical Devices Steering Committee and Working Groups
Keep up to date
For questions or comments, contact us at devices@tga.gov.au.
You can also send an email to devices@tga.gov.au 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.
More information
Page history
Added information on device regulation to Project Overview. Consolidated sections on key information and guidance into one section. Small text changes to enhance readability.
Original publication.
Added information on device regulation to Project Overview. Consolidated sections on key information and guidance into one section. Small text changes to enhance readability.
Original publication.