Australia's New Procedures for Recalls (PRAC) in Post-Market Surveillance Medical Devices

On March 5, 2025, the Australian Therapeutic Goods Administration (TGA) rolled out new guidelines called the ‘Procedures for Recalls, Product Alerts, and Product Corrections’ (PRAC), bringing important updates to how medical devices and other therapeutic products are handled after they hit the market. This new approach replaces the previous ‘Uniform Recall Procedure for Therapeutic Goods’ (URPTG) and aims to make the process smoother, faster, and more transparent, improving the overall safety of medical devices in Australia.

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These changes are especially important for foreign manufacturers who hold the marketing authorisation for their products through the Australian Register of Therapeutic Goods (ARTG). When an adverse event related to a medical device occurs in the Australian market, manufacturers must follow the Therapeutic Goods Act and the relevant regulations. Post-market surveillance ensures that patients, healthcare professionals, and users are protected by reducing risks and preventing recurring issues.

What’s Changed: Simplifying the Process

The new PRAC system streamlines the way medical device recalls and corrections are managed. Under the previous system, the URPTG had eight categories of actions, which could be confusing and complicated. PRAC simplifies this by merging those into four clear categories that are easier to understand and implement:

Recall: A product is pulled off the market due to safety concerns.

Product Alert: A notice to inform stakeholders about new safety information.

Product Correction: Modifications are made to a product, but it stays on the market.

Quarantine: A temporary halt in distribution while further checks are done.

These simplified categories are just the beginning. Here are some other key changes:

New Terminology: The confusing distinction between ‘recall’ and ‘non-recall’ has been replaced by a broader term: ‘market actions’.

Fewer Steps: The recall process has been simplified from 10 steps to just 5, speeding up response times.

Clearer Guidelines: The PRAC provides easy-to-follow documentation with tables and diagrams to explain the process.

More Accessible Definitions: The definitions of market share classifications and actions have been made simpler and clearer.

Better Communication: The TGA now takes on the responsibility of sending out sponsor-approved letters to customers. Sponsors will now be accountable for keeping their customer lists accurate to avoid delays.

For more serious situations—such as issues with radiopharmaceuticals, blood, tissue, or clinical trials—sponsors must quarantine the affected products immediately, notify everyone involved, and then consult with the TGA.

The Five Phases of Post-Market Surveillance

The PRAC process unfolds in five phases, each designed to make the management of recalls and corrective actions more efficient:

Problem Assessment: First, gather all relevant data and assess the risk posed by the product.

Notification to the TGA: The required documents are submitted to the TGA through their dedicated portal.

Review and Approval: The TGA reviews the case and issues an authorisation letter, allowing sponsors to move forward with their actions.

Market Action: Sponsors communicate with customers and manage their responses.

Process Closure: Finally, the process is closed with periodic reports, ensuring that everything is properly documented and finalized.

Understanding Market Risk Levels

PRAC also introduces a new way to classify market actions based on the level of risk:

Class I: These are critical issues requiring immediate action.

Class II: Moderate risks that need urgent corrective action.

Class III: Low-risk concerns with minimal impact on safety.

Depending on the situation, actions like recalls, corrections, alerts, or quarantines may be necessary.

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Why This Matters

The goal of these updates is to make recall and post-market surveillance processes faster, clearer, and more transparent, ensuring better public protection and compliance. These changes aim to improve patient safety and help manufacturers respond effectively to issues. Operon plays a vital role in this by offering regulatory consulting services, including CDSCO registration, US FDA 510(k), CE marking, and SFDA registration, along with turnkey solutions like manufacturing facility design, clean room guidance, QMS implementation, and plant layout optimization. By partnering with Operon, manufacturers can navigate complex regulations efficiently, ensuring compliance and faster market access, while maintaining high safety and quality standards.