TGA Annual Reporting Obligations for High-Risk Medical Devices

1. Overview and Purpose

The Therapeutic Goods Administration (TGA) requires sponsors of certain high-risk medical devices to submit annual reports for the first three years following inclusion in the Australian Register of Therapeutic Goods (ARTG). This requirement, under Regulation 5.11 of the Therapeutic Goods (Medical Devices) Regulations 2002, aims to confirm that devices continue to meet the Essential Principles for safety and performance, and that post-market surveillance can identify issues early. Source: https://www.tga.gov.au/resources/guidance/submitting-annual-reports-medical-devices

Reports cover data from both Australia and worldwide.

2. Devices Requiring Annual Reports

Annual reporting applies to:

• Implantable Class IIb devices
• Class III devices
• Active Implantable Medical Devices (AIMD), now classified as Class III

This focuses on high-risk devices new to the Australian market. Source: https://www.tga.gov.au/resources/guidance/submitting-annual-reports-medical-devices

3. Reporting Period and Deadlines

Reports cover the period from 1 July to 30 June and are due by 1 October each year. Key timing details:

• First report: Covers at least six months but no longer than 18 months after ARTG inclusion
• Subsequent reports: Submitted by 1 October for the next two years (total of three reports)
• If inclusion is between 1 July and 31 December, first report due the following 1 October
• If inclusion is between 1 January and 30 June, first report due the following 1 October

The TGA does not send reminders; failure to submit may lead to ARTG revocation. Source: https://www.tga.gov.au/resources/guidance/submitting-annual-reports-medical-devices

4. Required Information in Reports

Reports must be presented by product/model in a clear table format and include:

• ARTG number
• Product name(s)
• Model number(s)
• Number of devices supplied in Australia and worldwide
• Number of complaints in Australia and worldwide
• Number of adverse events and incident rates (Australia and worldwide)
• List of all complaints and adverse events with jurisdiction
• TGA Device Incident Report (DIR) numbers
• Details of regulatory/corrective actions or notifications

A template is available for structuring reports. Source: https://www.tga.gov.au/resources/guidance/submitting-annual-reports-medical-devices

5. Submission Process

Submit reports electronically via email to medicaldevicesurveillance@health.gov.au, addressed to the Annual Report Coordinator. Reports are treated as confidential and used for ongoing monitoring. The TGA reviews submissions and contacts sponsors only if further information is needed. Source: https://www.tga.gov.au/resources/guidance/submitting-annual-reports-medical-devices

6. Sponsor Responsibilities

Sponsors must ensure timely submission and accurate data. If limited data is available (e.g., device not supplied elsewhere), this should be stated. Reports support proactive identification of safety or performance concerns. Source: https://www.tga.gov.au/resources/guidance/submitting-annual-reports-medical-devices

7. Updates and Resources

Guidance published 21 June 2022, last updated 23 September 2024. Key resources include the annual report template (Excel file). Source: https://www.tga.gov.au/resources/guidance/submitting-annual-reports-medical-devices