On 19 June 2023, the TGA convened a National Symposium on point-of-care (POC) manufacturing of medical devices with representatives from other relevant regulators, and State and Territory health departments.
Topics included the current regulation of these kinds of devices, changes to the way these devices are manufactured and the unique risks associated with POC manufacturing models.
A meeting summary and follow-up actions are available on the TGA website.
Meeting participants agreed to collaborate with us to establish:
- An overarching POC Manufacturing of Medical Devices Steering Committee to maintain oversight of the work, provide advice and ensure delivery of objectives/outcomes.
- Sector-specific Working Groups to discuss and map current regulatory pathways in order to identify existing, and inform the development of appropriate, regulatory pathways for POC manufacturing of medical devices.
Terms of reference
The POC Manufacturing of Medical Devices Steering Committee and sector-specific Working Groups will work in tandem to:
- Review the current regulations, measures, and arrangements for point-of-care manufacturing activities.
- Establish clear boundaries between regulators and statutory bodies who have oversight of patient safety and point-of-care manufacturing activities.
- Identify areas where refinements may need to be made to:
- Address risks associated with the manufacture of medical devices at the point-of-care.
- Improve timely access to the most appropriate medical devices for patients.
- Reduce unnecessary financial, administrative, or regulatory burdens.
- Educate and communicate with stakeholders about their regulatory responsibilities.
The Steering Committee and Working Groups will deliver these outcomes via their separate and distinct roles.
Committee
The Steering Committee is tasked to:
- Maintain strategic oversight of the point-of-care manufacturing project
- Provide support and information to the sector-specific Working Groups to help guide their agreed activities.
- Identify and progress agreed refinements through relevant governance structures including providing advice to government at both Federal and State/Territory levels.
- Identify and engage with relevant stakeholders within their jurisdiction or remit to support the work of the point-of-care manufacturing project.
Membership
The members of the POC Manufacturing of Medical Devices Steering Committee will consist of representatives from the following organisations:
- Therapeutic Goods Administration (TGA)
- Australian Health Practitioner Regulation Agency (Ahpra)
- National Alliance of Self Regulating Health Professions (NASRHP)
- National Disability Insurance Agency (NDIA)
- The Australian Commission on Safety and Quality in Healthcare (ACSQHC)
- State and territory government health departments
- Engineers Australia – Biomedical College
Optional attendance at Steering Committee meetings is extended to representatives from:
- The Aged Care Quality and Safety Commission (ACQSC); and
- National Disability Insurance Scheme Quality and Safeguards Commission (NDISQSC).
Meetings and communiques
Frequency of meetings
The Steering Committee will meet approximately every two months.
Sector-specific Working Groups
There are three sector-specific point-of-care manufacturing of medical devices Working Groups:
- Allied Health Sector Working Group
- Complex Manufacturing Hubs in Healthcare Facilities Working Group
- Dental Sector Working Group
The Working Groups are tasked to:
- Provide an avenue for engagement with relevant professionals and other stakeholders involved in the manufacture of medical devices at the POC.
- Inform the Steering Committee of barriers and opportunities within the sector.
- Document existing structures or measures for regulation, licensing, professional development, accreditation, registration, education and/or qualifications.
- Develop and deliver sector-specific targeted communication and education for impacted stakeholders to support compliance.
Sector-specific Working Groups Membership
The sector-specific Working Groups will be chaired by the TGA with at least one representative from the Steering Committee present to support each Working Group.
The Working Group(s) membership will consist of up to two representatives and two observers nominated from relevant professional peak bodies, industry, State and Territory health departments and other regulators.
Allied Health Sector Working Group
The members of the POC Manufacturing of Medical Devices Allied Health Sector Working Group include:
- Therapeutic Goods Administration (TGA)
- Ahpra Occupational Therapy Board of Australia
- Ahpra Podiatry Board of Australia
- Allied Health Professions Australia (AHPA)
- Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM)
- Australian Hand Therapy Association (AHTA)
- Australian Orthotic Prosthetic Association (AOPA)
- Australian Podiatry Association (APODA)
- Department of Health, Australian Capital Territory
- Department of Health, New South Wales
- Department of Health, Queensland
- Department of Health, South Australia
- Department of Health, Tasmania
- Department of Health, Western Australia
- Engineers Australia – Biomedical College
- National Disability Insurance Agency (NDIA)
- National Alliance of Self Regulating Health Professions (NASRHP)
- Occupational Therapy Australia (OTA)
- Pedorthic Association Australia
Dental Sector Working Group
The members of the POC Manufacturing of Medical Devices Dental Sector Working Group include:
- Therapeutic Goods Administration (TGA)
- Ahpra Dental Board of Australia
- Australian Commission on Safety and Quality in Health Care
- Australian Dental and Oral Health Therapists Association (ADOHTA)
- Australian Dental Association (ADA)
- Australian Dental Industry Association (ADIA)
- Australian Dental Prosthetists Association (ADPA)
- Australian Dental Technicians Association (ADTA)
- Australian and New Zealand Association of Oral and Maxillofacial Surgeons (ANZAOMS)
- Australian Society of Orthodontists (ASO)
- Dental Hygienists Association of Australia (DHAA)
- Dental Implant Registry (DIR)
- Department of Health, Australian Capital Territory
- Department of Health, New South Wales
- Department of Health, Queensland
- Department of Health, South Australia
- Department of Health, Tasmania
- Department of Health, Victoria
- Department of Health, Western Australia
Complex Manufacturing Hubs in Healthcare Facilities Working Group
The members of the POC Manufacturing of Medical Devices Complex Manufacturing Hubs in Healthcare Facilities Working Group include:
- Therapeutic Goods Administration (TGA)
- NSW - John Hunter Hospital
- NSW - Westmead Hospital
- WA - Royal Perth Hospital
- VIC - Royal Melbourne Hospital
- QLD - Herston Biofabrication Institute
- NSW - Chris O’Brien Lifehouse
- Stryker R&D Lab (based at the Royal Brisbane and Women’s Hospital, QLD)
- Australian Commission on Safety and Quality in Healthcare (ACSQHC)
- Australian Research Council Training Centre for Medical Implant Technologies (ARC CMIT) – University of Melbourne and Griffith University
- Day Hospitals Association
- Department of Health, Western Australia
- Department of Health, New South Wales
- Department of Health, Queensland
- Department of Health, Australian Capital Territory
- Engineers Australia – Biomedical College includes the National Committee of Rehabilitation Engineering (NCRE)
- Sydney Biomedical Accelerator
Meetings and communiques
Outcomes from each Working Group will be reported back to the Steering Committee for consideration, including to inform the development of any potential refinements to regulation, supporting guidance, and the delivery of education and communication strategies.
Frequency of meetings
The sector specific Working Groups will meet every two months, 10-15 days after the Steering Committee meeting.
Steering Committee Meeting Communiques
Steering Committee Meeting Communiques
Steering Committee Meeting #2 communique, 5 March 2024
Steering Committee Meeting #1 communique, 17 November 2023
Allied Health Sector Working Group Meeting Communiques
Allied health sector Working Group Meeting #1 communique, 27 November 2023
Complex Manufacturing Hubs in Healthcare Facilities Working Group Meeting Communiques
Dental Sector Working Group Meeting Communiques
Dental sector Working Group Meeting #1 communique, 29 November 2023
Contact us
Outcomes
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Meeting statementsA meeting statement from the second meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available.
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Meeting statementsA meeting statement from the Point-of-care Manufacturing of Medical Devices Complex Manufacturing Hubs in Healthcare Facilities Working Group is now available.
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Meeting statementsA meeting statement from the first meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available.