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

Advisory details

Purpose

To describe the legislated requirements for health service organisations to report medical device related adverse events.

Issue

The Therapeutic Goods Amendment (2022 Measures No.1) Act 2023 is supported by amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 and came into effect on 21 March 2025.

The legislation establishes a framework for the mandatory reporting of medical device adverse events by healthcare facilities and requires Chief Executive Officers (or equivalent) of health service organisations (including public hospitals, private hospitals and day-hospital facilities) to report serious adverse events involving a medical device to the Therapeutic Goods Administration (TGA).

This relates to Action 1.11 of the National Safety and Quality Health Service Standards which requires health service organisations to have organisation-wide incident management and investigation systems, and: 

1. Support the workforce to recognise and report incidents
2. Support patients, carers and families to communicate concerns or incidents
3. Involve the workforce and consumers in the review of incidents
4. Provide timely feedback on the analysis of incidents to the governing body, the workforce and consumers
5. Use the information from the analysis of incidents to improve safety and quality
6. Incorporate risks identified in the analysis of incidents into the risk management system
7. Regularly review and acts to improve the effectiveness of the incident management and investigation systems.

Transition arrangements from March 2025

Transition arrangements are based upon the level of harm that may occur, with a focus in the earlier stages on reporting of the most serious adverse events. Health service organisations are encouraged to report adverse events involving lower risk medical device classifications and near misses or treatment outcomes. 

From 21 March 2025 a 12-month transition period commenced, whereby health service organisations are encouraged to report medical device related adverse events to the TGA. Reporting is voluntary. The transition period is intended to allow time for facilities to implement and evaluate their reporting capability. 

From 21 March 2026, reporting by health service organisations will become mandatory for all adverse events resulting in death, serious injury and serious deterioration associated with high-risk medical devices. High-risk medical devices include:

• Class III medical devices
• Class 4 IVD medical devices.

From 1 April 2028 reporting by health service organisations will be expanded to include medium-risk medical devices and near miss adverse events involving the following classes of medical devices:

• Class IIa medical devices
• Class IIb medical devices
• Class III medical devices
• Class 3 IVD medical devices.
• Class 4 IVD medical devices.

From 1 April 2030, reporting by health service organisations will expand to also include treatment for serious injury. This is the final stage of implementation.

Reporting

Reporting will be in line with TGA requirements, listed on the TGA website, https://www.tga.gov.au/safety/reporting-problems/reporting-adverse-events

Reports on medical device related adverse events that resulted in death or serious deterioration must be provided within 10 days. The 10-day period begins from the day of death or the day the serious deterioration in the health of the person was first identified within a health service organisation.

Reports on medical device-related near misses and treatment-related incidents must be provided within 45 days. The 45-day period begins from the date of intervention (for near misses) or the date the treatment was provided for serious deterioration. The TGA encourage healthcare facilities to submit batch reports on the first business day of each month for consistency and ease of processing.

Medical device adverse event reports are to be sent to the TGA.

They may be sent to the Australian Commission on Safety and Quality in Health Care at ACSQHCmedicaldevices@safetyandquality.gov.au The Commission will forward reports to the TGA.

Requirements

Health service organisations must implement systems to report medical device related adverse events and near misses as defined in the Act and the accompanying Regulations by the dates outlined in this advisory.

During an accreditation assessment assessors will ensure health service organisation has implemented a system that complies with the requirements for reporting and monitoring reportable adverse events involving medical devices from March 2026 .

Assessors will rate Action 1.11 as ‘Met’ where the health service organisation has implemented a system that complies with the requirements for monitoring and reporting reportable adverse events involving medical devices from 21 March 2026.