While the consultation is open you can make a submission at our TGA consultation hub.
We review the submissions carefully. After that the submissions and our decision will be available on the same page at the TGA consultation hub.
About this consultation
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed regulatory changes to strengthen safety oversight of clinical trials for medical devices:
- To increase the degree of regulatory oversight of clinical trials of certain unapproved, high-risk medical devices.
- To include clinical trials of all medical devices in Australia's Good Clinical Practice Inspection Program (to enable selected trials and documentation supporting these trials to be inspected).
All recent TGA consultations can be found at the TGA consultation hub.
Consultation documents
Contents
- Introduction
- Background
- Clinical trials regulation in Australia
- Proposed changes
- CTA approval for clinical trials of certain high-risk devices
- Include medical devices in the GCP Inspection Program
- Benefits of the proposed changes
- Your input is valuable to us
- How to submit
- Enquiries
All recent TGA consultations can be found at the TGA consultation hub.
Topics