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Clinical Trial Pathways

Overview​

Medical devices used in clinical trials in Australia are generally exempt from the requirement to be included in the ARTG, provided the trial is conducted under an approved pathway. This exemption recognises that requiring full ARTG inclusion before a device can be trialled would prevent evidence generation — defeating the purpose of the pre-market evidence requirements.

Two schemes govern clinical trials of therapeutic goods in Australia: the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme. Almost all medical device trials use the CTN scheme.

Clinical Trial Notification (CTN) Scheme​

How it works​

Under CTN, the trial sponsor notifies the TGA of the trial — it is a notification, not an application for approval. The substantive oversight responsibility sits with a Human Research Ethics Committee (HREC), not the TGA.

Process:

  1. The trial sponsor (the entity responsible for the trial, often the manufacturer or an academic institution) prepares the trial protocol and safety documentation
  2. The sponsor submits the protocol to an HREC for ethical review and approval
  3. The HREC assesses the scientific merit and safety basis of the trial
  4. If the HREC approves, the trial sponsor notifies the TGA using the CTN form before the trial commences
  5. The TGA acknowledges receipt — it does not approve or reject the notification
  6. The trial proceeds under ongoing HREC oversight

TGA's role under CTN​

Despite not pre-approving CTN trials, the TGA retains the power to:

  • Inspect trial sites for compliance with Good Clinical Practice (GCP)
  • Require the trial to cease if serious safety concerns arise
  • Require reporting of serious adverse events from the trial

ARTG exemption conditions​

The ARTG exemption for clinical trial devices applies provided:

  • The trial is conducted under a valid CTN or HREC approval
  • The device is used only within the scope of the trial
  • The trial complies with GCP requirements (ISO 14155 for medical device trials)
  • Serious adverse events are reported to the TGA and HREC within required timeframes

Clinical Trial Approval (CTA) Scheme​

Under CTA, the TGA itself assesses and approves the trial before it commences — reviewing the safety and scientific data submitted by the sponsor. This pathway is more burdensome and is used in limited circumstances, including:

  • Where an HREC is not satisfied with available safety data and refers the trial to the TGA
  • Where the TGA requires CTA for specific product categories

The vast majority of medical device trials in Australia proceed under CTN rather than CTA.

Good Clinical Practice (GCP) for Medical Device Trials​

Clinical investigations of medical devices in Australia must comply with GCP requirements. The applicable standard is ISO 14155 — Clinical investigation of medical devices for human subjects, which covers:

  • Clinical investigation plan (protocol) requirements
  • Informed consent procedures
  • Investigator and sponsor responsibilities
  • Adverse event reporting within the trial
  • Data integrity and monitoring requirements
  • Site management and auditing

The TGA conducts GCP inspections of clinical trial sites. Non-compliance with GCP can result in the trial being suspended and data from the trial being rejected.

Post-Trial Pathway to ARTG Inclusion​

Clinical trial data generated in Australia (or accepted from overseas trials) forms part of the clinical evidence required under Essential Principle 14 for ARTG inclusion. After a successful trial:

  1. The manufacturer compiles the clinical evaluation report incorporating trial results
  2. The sponsor applies for ARTG inclusion with the full evidence package
  3. The appropriate conformity assessment procedures must still be applied
  4. For high-risk devices, the TGA may conduct an application audit reviewing the clinical trial data

Where a device is being studied in a clinical trial and a patient outside the trial has a serious condition for which no alternative exists, early access may be possible under SAS Category A. This requires notification to the TGA within 28 days of first supply, but does not require prior approval. The trial sponsor and HREC should be notified of any compassionate use occurring outside the trial.​

Where a device is being studied in a clinical trial and a patient outside the trial urgently needs access, the SAS or Authorised Prescriber pathways can be used alongside the ongoing trial — they are not mutually exclusive.

Reporting Obligations During Trials​

Trial sponsors must report to both the TGA and HREC:

  • Serious adverse events occurring during the trial
  • Unexpected serious adverse device effects
  • Device deficiencies that could have led to a serious adverse event

Timeframes for reporting vary depending on severity — generally 7–15 days for life-threatening events.

Official Sources​