Annual Reports (Class III, AIMD, IIb Implants)
Overview
Certain high-risk device classes are subject to mandatory annual reporting obligations to the TGA after ARTG inclusion. Annual reports provide the TGA with ongoing assurance that devices continue to meet the Essential Principles and that the benefit-risk profile remains acceptable. Annual reporting is a condition of inclusion — failure to submit required annual reports on time is a breach of ARTG conditions and can result in suspension or cancellation of the ARTG entry.
Which Devices Require Annual Reports
Class III medical devices Annual reports are required for a minimum of 3 years after ARTG inclusion. After 3 years, the TGA assesses whether continued annual reporting is necessary based on the device's post-market safety profile.
AIMD (now classified as Class III) Same as Class III requirements above.
Implantable Class IIb devices Certain implantable Class IIb devices are also subject to annual reporting requirements. Check the TGA guidance on your specific device type to confirm whether annual reporting applies.
What Annual Reports Must Include
Annual reports are submitted by the sponsor and must include:
- Post-market surveillance summary — a summary of PMS activities conducted since the last report, including data sources reviewed and key findings
- Adverse event data — summary of adverse events and near adverse events reported to the TGA during the period, and overseas events for devices supplied in Australia
- Clinical evidence update — confirmation that the clinical evidence continues to support the device's safety and performance, or an updated clinical evaluation if new evidence has emerged
- Risk management update — any changes to the device's risk profile identified through PMS
- Status of corrective actions — any field safety corrective actions or recalls undertaken during the period and their status
- Supply data — volume of devices supplied during the reporting period
- Conformity assessment status — confirmation that conformity assessment certificates remain current and valid
- Significant changes — any changes to the device, its labelling, or its intended purpose during the period
Reporting Timeframes
Annual reports are due on the anniversary of the ARTG inclusion date, unless the TGA specifies a different timeframe. The TGA notifies sponsors of their annual reporting obligations and due dates. Reports must be submitted through the TGA's eBusiness Services (eBS) portal.
Annual Reporting After the Mandatory Period
After the mandatory 3-year annual reporting period for Class III devices, the TGA will assess whether ongoing annual reporting is required. This assessment is based on the device's post-market safety profile, the quality of PMS conducted, and any outstanding safety questions. Many Class III devices continue to be subject to annual reporting beyond the initial 3-year period.