AMA urges greater transparency in medical device safety reviews
15 Oct 2026
The AMA said reports should include cases where devices remain compliant or no formal regulatory action is taken. Publishing only negative findings could give patients and healthcare professionals an incomplete picture of a device’s safety.
Clearer reporting would help doctors make informed treatment decisions and give patients greater confidence when reviews find that a device remains safe and suitable for use.
The AMA recommends that information about medical devices should be:
- Timely and easy to find: Safety and performance information should be accurate, searchable and useful for clinical decisions.
- Clearly categorised: Preliminary safety concerns, ongoing reviews, voluntary corrective actions, completed reviews with no regulatory action and formal decisions should be clearly distinguished.
- Shared directly when action is needed: Relevant health services, doctors and affected patients should be contacted when findings require clinical action.
- Supported by strong safety monitoring: The AMA wants continued oversight of medical devices, including exempt devices and information about their sponsors.
Protecting public safety: Commercially sensitive details should remain confidential where needed, but the TGA must still identify affected devices and explain safety concerns and investigation findings.
The AMA said protecting public health and supporting the safe use of medical devices should remain the priority.
It supports the proposed changes to improve transparency and clinical decision-making. The submission also recommends reviewing the changes after implementation to check whether the information is timely, useful and easy to understand.
AMA urges greater transparency in medical device safety reviews
Source: Australian Medical Association (AMA).