New recall procedures in Australia: what changes with PRAC?
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
March 5, 2025, marked a significant step forward in the regulation of medical device recalls in Australia. The Therapeutic Goods Administration (TGA) has introduced the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC), replacing the previous Uniform Recall Procedure for Therapeutic Goods (URPTG).
This reform simplifies the market action management process, ensuring greater clarity, speed, and efficiency for manufacturers and distributors of medical devices.
Why Was a Change Necessary?
The previous system posed several operational challenges that hindered the effectiveness of recalls and product corrections. Some of the main issues included:
- Overly complex and lengthy processes, with procedures requiring up to 10 mandatory steps;
- Unclear terminology, with eight different categories of market actions that created confusion among manufacturers;
- Excessive bureaucracy, making it difficult to provide a timely response to safety concerns.
To address these challenges, TGA implemented PRAC, aiming to make the system simpler and more functional for all stakeholders involved.
Key Changes Introduced by PRAC
PRAC brings significant modifications that will directly impact companies in the industry:
1️⃣ Simplified Terminology The eight categories of market actions have been reduced to four:
- Recall: Removal of a product from the market for safety reasons;
- Product Alert: Public notification of a potential issue without product withdrawal;
- Product Correction: Corrective actions for distributed devices without market removal;
- Quarantine: Temporary product hold for safety assessments.
2️⃣ Faster and More Effective Recall Process The mandatory recall process steps have been reduced from 10 to 5, allowing for a more agile response to emergencies.
3️⃣ Improved Documentation TGA instructions are now clearer and less redundant, making it easier to understand and apply the new regulations.
4️⃣ IT System Upgrades Over the coming months, TGA will also update its digital tools. The SARA database will be replaced by the new DRAC (Database for Recalls, Product Alerts, and Product Corrections), offering greater transparency and advanced functionalities for managing recalls.
What Are the Implications for Medical Device Manufacturers?
These changes are not just a regulatory update; they represent a real transformation in medical device safety management. For manufacturers and distributors, this means:
- Faster recall actions, reducing the risk of penalties;
- Less uncertainty and clearer procedures to follow;
- Greater patient safety and lower reputational risk;
- More efficient document management with lower administrative costs.
Common Questions About the PRAC Procedure
Is PRAC Mandatory for All Recalls in Australia?
Yes. PRAC is the official TGA protocol for all recalls and corrective actions involving therapeutic goods.
How Are Product Alerts Different from Recalls?
Product alerts do not involve removing products from the market but aim to notify the public of potential risks.
What Are the Penalties for Non-Compliance?
Failure to comply may result in legal action, financial penalties, or revocation of TGA registration.
Expert Tips for Navigating the PRAC Transition
Leverage Technology for Better Recall Management
Consider using automated compliance platforms that integrate with the upcoming DRAC system to streamline reporting.
Collaborate with a TGA Sponsor for Smooth Compliance
A qualified TGA Sponsor can provide expert guidance and ensure your company remains aligned with new regulations.
Conclusion
The introduction of PRAC marks a positive change for the medical device industry in Australia, offering a more streamlined, effective, and transparent system for managing recalls and corrections.
Companies must actively prepare to comply with the new procedures and leverage this opportunity to enhance their regulatory compliance and responsiveness in critical situations.
Want to learn more about how to manage this transition effectively? Read the official TGA statement here or contact us for personalized support!
As a TGA Sponsor, we provide comprehensive support for regulatory compliance and medical device management in Australia. If you need assistance in adapting to the new PRAC procedures, reach out to us for dedicated consultation!
