Mandatory reporting of medical device-related adverse events: Is your organisation prepared?

In Australia, healthcare facilities now face new regulatory requirements around the reporting of adverse events related to medical devices. Under recent updates from the Therapeutic Goods Administration (TGA), it is mandatory for healthcare facilities to report specific information whenever a medical device causes, or could cause, a serious deterioration in a patient's health or death.

While the goal of these changes is to strengthen patient safety and improve monitoring of device performance, meeting these mandatory reporting obligations can add another layer of complexity to already stretched clinical and administrative teams.

At Cgov, we understand these challenges, and we’re here to help. Our Quality Management Solutions (QMS) provides healthcare organisations with the tools they need to help stay compliant, manage reporting efficiently, and maintain high standards of patient care.

Healthcare facilities must now report a minimum set of data when submitting adverse event reports related to medical devices. The required information includes:

• Healthcare facility identifier: An auto-generated, unique code assigned to each facility.
• Date and time of incident: Accurate recording of when the adverse event occurred.
• Comprehensive description of the incident: A detailed narrative explaining what happened.
• Extent of injury: Including any death or serious deterioration in health, and a description of the impact.
• Name and description of the device: Identifying the device involved.
• Device manufacturer: If known, to assist the TGA in product investigations.

Each of these fields must be completed accurately to ensure timely investigation, transparency, and regulatory compliance.

While the new regulations are critical for safeguarding patient health, they also present significant operational challenges for healthcare organisations. Facilities must ensure that:

• Data is collected accurately: Missing or incomplete fields can delay investigations and expose organisations to compliance risks.
• Staff are trained and aware: Clinical and administrative teams must know what events need to be reported and how to document them correctly.
• Processes are efficient and scalable: Manual or paper-based systems increase the risk of errors, lost information, and reporting delays.

Without a robust system in place, healthcare facilities risk non-compliance, increased administrative burden, and potential reputational damage.

Cgov’s Quality Management Solutions (QMS) is designed to simplify mandatory reporting, reduce administrative effort, and support healthcare facilities in maintaining compliance with the TGA’s requirements.

Our QMS features a dedicated incidents module, allowing healthcare organisations to accurately capture, categorise, and manage adverse event reports. Each incident can be validated, investigated, and closed with a documented outcome, to help ensure a complete and compliant process.

Importantly, the TGA highlights that adverse events are not always caused by the device itself — they can result from user interaction, external factors, or even near misses. In these cases, Cgov’s QMS enables organisations to initiate a Quality Improvement initiative directly from the incident report. Similarly, associated risks can also be identified and managed within the system, helping organisations to drive continuous improvement and enhance patient safety.

Cgov’s QMS can help your organisation to:

• Capture required fields easily: Our system helps you to ensure that every mandatory field, from facility identifier to device manufacturer, is accurately recorded.
• Streamline the reporting process: Automated workflows guide users through each step, reducing human error and improving data quality.
• Maintain a compliant, complete data set: All adverse event information is stored securely and is easily accessible for auditing or review purposes.
• Generate reports aligned with TGA standards: Our solution makes it simple to compile and submit required reports without unnecessary duplication of effort.
• Adapt to your organisation’s needs: Whether you are a small healthcare facility or a large hospital network, Cgov’s QMS can be tailored to suit your structure and processes.
• Promote continuous improvement: By linking incidents to quality initiatives and risk management processes.

Our approach means you can focus on patient care while feeling confident that your reporting obligations are being met.

Mandatory reporting is more than a regulatory requirement; it plays a crucial role in improving the safety and effectiveness of medical devices across the healthcare sector. By contributing accurate and timely reports, healthcare facilities help identify risks earlier, prevent further incidents, and drive improvements in device design and regulation.

Implementing a strong reporting framework not only protects patients but also supports your organisation’s reputation for quality and responsibility.

If your organisation is looking for a better way to manage mandatory adverse event reporting, now is the time to act.

Register for a QMS demo today and discover how Cgov’s Quality Management Solutions can help simplify your reporting obligations, strengthen compliance, and support safer patient outcomes.