Post-Market Surveillance: Sponsor's Role in TGA Vigilance

Australia Post-Market Surveillance: Sponsor's Role in TGA Vigilance

Post-Market Surveillance (PMS) is a mandatory requirement for all medical devices listed on the Australian Register of Therapeutic Goods (ARTG) and is critical for maintaining market authorization. The system is managed by the Therapeutic Goods Administration (TGA), with the Australian Sponsor serving as the primary party responsible for vigilance reporting.

The Australian Sponsor's Core Responsibilities

The Australian Sponsor acts as the local regulatory point of contact and is required to manage all post-market reporting activities on behalf of the manufacturer. These responsibilities include:

• Reporting Adverse Incidents: Submitting reports of all adverse events and complaints that occur in Australia directly to the TGA.
• Reporting Overseas Actions: Reporting any regulatory actions taken by other countries, such as recalls, field safety notices, or safety alerts.
• Managing Information: Establishing procedures to continually monitor device performance and promptly obtaining the results of manufacturer investigations, clinical studies, and reviews related to adverse events.
• Maintaining Distribution Records: Keeping records of device distribution to facilitate potential recalls or TGA queries.

TGA Vigilance and Regulatory Action

The TGA reviews adverse event reports and, if necessary, an expert panel evaluates them. TGA action resulting from post-market vigilance may include:

• Recalls: Withdrawal of a device from the market.
• Hazard or Safety Alerts: Issuing warnings to healthcare professionals and the public.
• Surveillance Audits: Initiating audits of manufacturing sites.
• Product Modifications: Requiring changes to the device or its labeling.

Specific Reporting Requirements for High-Risk Devices

Sponsors of the highest-risk devices have an additional, mandatory reporting obligation to the TGA:

• Devices Affected: Active Implantable Medical Devices (AIMD), Class III devices, and implantable Class IIb devices.
• Report Type: The Sponsor must submit three consecutive annual reports to the TGA after the device's listing on the ARTG.
• Report Content: These annual reports must include all complaints received by the manufacturer that relate to product usage issues, providing a comprehensive overview of the device's performance in the field.

Effective PMS is essential for ensuring ongoing compliance with the Essential Principles and preventing the suspension or cancellation of the device's ARTG inclusion.