TGA, December 29, 2025 — The Therapeutic Goods Administration (TGA) in Australia has released updated guidance on the Authorised Prescriber Scheme, clarifying how unapproved therapeutic goods including medical devices can be supplied legally before full registration. This update is a key development for device makers exploring early patient access in Australia. The TGA’s refreshed guidance outlines the regulatory framework that allows medical practitioners to prescribe unapproved medical devices to patients with serious or life‑threatening conditions via the Authorised Prescriber Scheme. Importantly, the document explains how manufacturers and sponsors can support authorised prescribers while meeting reporting and safety obligations.
WHAT’S CHANGED FOR MANUFACTURERS?
Two Pathways, One Goal: Early Patient Access
The guidance confirms two main routes for access:
- Established History of Use Pathway: A simplified option for certain listed goods (primarily medicines).
- Standard Pathway: Applies broadly to medical devices and requires specialist endorsement and clinical justification.
For most device manufacturers, the Standard Pathway is the one to prioritise offering a way to get your unapproved device into practice ahead of full TGA approval, if a specialist clinician supports it.
TIMELINE & REPORTING OBLIGATIONS
Once a device is supplied under the scheme:
- Six‑monthly reports are now required, detailing quantities supplied and usage.
- Adverse event reporting rules apply, with serious incidents needing quick notification (7–15 days, depending on severity).
- Devices can only be supplied after the prescriber receives a formal TGA approval letter.
Compliance with these timelines is critical; missed reports or safety notifications can jeopardise access under the scheme.
WHO CAN PRESCRIBE?
Only specialist medical practitioners properly registered and experienced in the relevant therapy area can become Authorised Prescribers. Dentists, nurses, and provisional registrants are not eligible under this route.
Key Manufacturer Responsibilities
To support compliant supply under the scheme, manufacturers must:
- Work closely with prescribers to prepare strong clinical justification and evidence.
- Ensure timely submission of reports.
- Maintain a robust system for handling and reporting adverse events.
- Avoid any form of public promotion of unapproved devices.
These obligations ensure that early access does not compromise patient safety or regulatory integrity.
WHAT HAPPENS IF A REGISTERED ALTERNATIVE EXISTS?
A notable control in the guidance is that if an ARTG‑approved device becomes available that meets the same clinical need, the unapproved device may no longer be supported under the Authorised Prescriber Scheme unless a new justification is made and accepted.
This underscores the importance of strategic planning: while the scheme opens doors, it also places equal emphasis on post‑market compliance and alignment with full approval processes.
IMPACTED STAKEHOLDERS
- Manufacturers & Sponsors: Can leverage the scheme to introduce novel technologies earlier but must support reporting and compliance.
- Specialist Prescribers: Must be credentialed and provide strong patient‑specific justification.
- Regulatory Teams: Need to monitor reporting deadlines and safety data flow closely.
WHY THIS MATTERS NOW
This update signals a more structured approach by the TGA toward controlled early access for medical devices. For manufacturers with breakthrough technologies still awaiting full registration, the Authorised Prescriber Scheme offers a strategic pathway to real‑world use if regulatory and clinical support structures are well aligned.
Stay tuned for further TGA guidance updates, including potential extensions of reporting templates and prescriber‑support tools.