Proposed regulatory changes for clinical trials of medical devices


Regulatory changes have been proposed by the Therapeutic Goods Administration (TGA) for clinical trials of medical devices, and AusBiotech is calling for feedback from affected members as it considers the impact on industry.

The proposed changes include:

  1. Increased regulatory oversight of clinical trials of certain unapproved, high-risk medical devices.
  2. Inclusion of all medical device clinical trials in Australia’s Good Clinical Practice (GCP) Inspection Program (to enable selected trials and documentation supporting these trials to be inspected).

All medical device trials in Australia have utilised the Clinical Trial Notification (CTN) pathway over the last five years (between 120-210 per year) and the TGA has received no Clinical Trial Approval (CTA) applications. While this may be appropriate in many instances, it allows novel permanently implantable investigational medical devices to be used in humans without review by the TGA.

Over time, medtech has increased in complexity and some emerging medical devices are posing an increasingly higher risk to patient safety; whilst regulatory changes have been implemented affecting the regulation of devices with these innovations that are marketed, no oversight is currently mandated for these devices used in the context of clinical trials.

It is proposed that certain invasive or implantable medical devices that have not previously been used or studied in people would be required to obtain TGA approval through the CTA pathway – the CTN would no longer be an available option. It is estimated that this proposed change would impact less than ten-per-cent of medical device clinical trials would be affected by the proposal.

In addition to targeting certain unapproved, high-risk medical devices, the TGA is also proposing to include all medical devices in its Good Clinical Practice (GCP) Inspection Program. Clinical trials of medical devices are already legally required to comply with the medical device GCP standard, however, the TGA does not currently conduct inspections of these sites, as they do for medicines and biologicals. This contrasts with regulators in comparable jurisdictions, such as the USA, UK, Canada and Japan.

The TGA’s proposed changes aim to assure the public that the rights, safety, and well-being of clinical trial participants are protected and that the trial data generated are credible.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science sector.

AusBiotech’s response to this consultation is being considered in collaboration with its AusMedtech Regulatory Affairs and Clinical Trials Advisory Groups.

To find out more on the consultation and to view the documents, click here.

Affected members are encouraged to contact Karen Parr, Director of Communications and Policy at AusBiotech by Friday 16 September 2022.