Point-of-care manufacturing of medical devices

Work is ongoing to review medical device regulations for point-of-care (POC) manufacturing.

Last updated

8 May 2025

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

Personalised medical devices

7 May 2025

Page

Information about how we regulate personalised medical devices.
Medical devices

Section

A 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.