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Medical device reforms: point-of-care manufacturing of medical devices

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

Last updated

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

Stakeholder engagement

Surveys

In 2023, to start gathering information for the review of current regulations, we conducted four (4) surveys targeting specific sectors where POC manufacturing takes place:

  1. The allied health sector
  2. The dental sector
  3. Manufacturing hubs within hospitals
  4. 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

Targeted consultation on potential options for regulatory refinement

Targeted consultation on potential options for regulatory refinement

The TGA has commenced discussions with stakeholder groups to consider potential options for refining the regulation of patient-matched medical devices, including those manufactured at the POC.

These discussions involve state and territory representatives, the Point-of-Care Manufacturing Steering Committee, the sector-specific working groups, and consumer groups. The feedback received is informing our ongoing work in shaping regulatory refinements prior to public consultation in 2026. 

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 framework
  • details about webinars and workshops.

More information

Product types

Page history

Show all page updates (3)

Added 'targeted consultation on potential options for regulatory refinement' section.

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 'targeted consultation on potential options for regulatory refinement' section.

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.