New Advisory: AS25/01 – Mandatory reporting of medical device adverse events

Before the year ends the Australian Commission on Safety and Quality in Health Care (the Commission) has released a new Advisory AS25/01: Mandatory reporting of medical device adverse events, applicable to all health service organisations and approved accrediting agencies.

Advisory AS25/01 outlines new legislative reporting obligations for adverse events involving medical devices under amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, which came into effect on 21 March 2025. It establishes mandatory reporting requirements aligned to Action 1.11 of the National Safety and Quality Health Service (NSQHS) Standards.

While assessors and accrediting agencies may identify risks during assessment, the health service organisation remains solely responsible for recording the risk and meeting all mandatory reporting requirements.

Key requirements for health service organisations

Health service organisations must ensure that organisation-wide incident management and investigation systems are in place to identify, manage and report adverse events involving medical devices.

This includes:

• Supporting staff to recognise and report medical device incidents and near misses
• Capturing and analysing risks and treatment-related incidents
• Using this data to drive continuous improvement and inform risk management systems, and
• Providing feedback to relevant stakeholders including the governing body, workforce, and consumers

Organisations must also report medical device adverse events to the Therapeutic Goods Administration (TGA) within specified timeframes:

• Within 10 days for events involving death or serious deterioration, and
• Within 45 days for near misses and treatment-related incidents.

Accreditation assessment requirements

As per the Commission’s advice, from 21 March 2026, accreditation assessments will include confirmation that health service organisations have implemented appropriate systems for managing and reporting adverse events involving medical devices.
Accrediting agencies will assess compliance with these requirements under NSQHS Standards, Action 1.11. Where these systems are not in place, the rating for Action 1.11 may be affected. Importantly, accreditation assessments do not replace the organisation’s legal obligations to report to the TGA.

Expectations for assessors

During assessments, assessors will:

• Confirm that effective systems for reporting and managing medical device adverse events are in place, and
• Reinforce organisational responsibilities where risks or incidents are identified.

Assessors are not responsible for:

• Investigating the clinical details of adverse events, and
• Reporting adverse events to the TGA.

Please ensure you refer to the details of Advisory AS25/01 on the Commission’s website. If you have any questions please reach out to our QIP Clinical Services Team who will be more than happy to assist.