Who Must Report Adverse Events for Medical Devices – TGA Obligations

1. Mandatory Reporting Obligations

Under the Therapeutic Goods Act 1989 and associated regulations, certain parties are legally required to report adverse events involving medical devices included in the Australian Register of Therapeutic Goods (ARTG). The primary obligation rests with the sponsor of the device. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/obligations-report-adverse-event-medical-devices

Sponsors must report when they become aware of information that:

• Indicates or suggests a death or serious injury/death associated with the device
• Indicates a deterioration in the health of a patient, user or other person
• Could lead to death or serious injury if the problem recurs

2. Who Is Considered the Sponsor

The sponsor is the person or company responsible for importing, exporting, or manufacturing the device and having it included in the ARTG. This includes:

• Australian-based entities that import or manufacture devices
• Overseas manufacturers who appoint an Australian sponsor
• Entities that modify or repackage devices in a way that changes their regulatory status Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/obligations-report-adverse-event-medical-devices

Only the current sponsor listed in the ARTG is required to report under the mandatory scheme.

3. Additional Reporting Responsibilities

While the primary obligation lies with the sponsor, other parties may have reporting duties:

• Manufacturers (especially overseas) must report to the sponsor any information that could affect safety or performance
• Importers and exporters may have obligations if they are also the sponsor
• Users (healthcare professionals, hospitals) are encouraged to report voluntarily, and under certain reforms, mandatory user reporting for serious incidents is being considered or implemented in stages Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/obligations-report-adverse-event-medical-devices

Voluntary reporting by anyone (including patients) is always welcomed and contributes to safety monitoring.

4. What Must Be Reported

Reportable information includes:

• Any malfunction, deterioration, or performance issue that could lead to harm
• Serious injury or death associated with the device (even if causality is uncertain)
• Trends or clusters of less serious events that may indicate a systemic problem
• Any new information that changes the risk-benefit profile of the device Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/obligations-report-adverse-event-medical-devices

Reports should be submitted as soon as possible after becoming aware of the issue, ideally within specified timeframes for serious events.

5. How to Report – The IRIS System

All mandatory reports must be submitted through the TGA's online Incident Reporting and Investigation Scheme (IRIS) system. The system:

• Provides structured fields to ensure complete information
• Generates a unique Device Incident Report (DIR) number for tracking
• Allows attachment of supporting documents Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/obligations-report-adverse-event-medical-devices

Sponsors should ensure their contact details are up to date to receive follow-up requests or questionnaires.

6. Consequences of Non-Reporting

Failure to comply with mandatory reporting obligations is a breach of the Therapeutic Goods Act and may result in:

• Regulatory sanctions
• Civil or criminal penalties
• Suspension or cancellation of ARTG inclusion
• Reputational damage Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/obligations-report-adverse-event-medical-devices

Prompt and accurate reporting is essential for maintaining compliance and protecting public health.

7. Support and Guidance

The TGA provides detailed guidance, including:

• Step-by-step instructions for IRIS reporting
• Examples of reportable and non-reportable events
• Contact details for the Device Incident Team
• Links to related resources and FAQs Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/obligations-report-adverse-event-medical-devices

Sponsors are encouraged to establish robust internal systems for capturing, investigating, and reporting adverse events to meet their obligations effectively.

These reporting obligations form a cornerstone of Australia's medical device post-market surveillance system, helping ensure devices remain safe and perform as intended throughout their lifecycle.