Earlier this year Australia’s medical device landscape entered a new era of post-market regulation. On 5 March 2025, the Therapeutic Goods Administration (TGA) implemented the Procedures for Recalls, Product Alerts, and Product Corrections (PRAC) — a major overhaul of Australia’s recall and post-market surveillance system. This new framework replaced the former Uniform Recall Procedure for Therapeutic Goods and introduces what the TGA calls a more efficient, transparent and responsive process for managing product issues.
For medical device manufacturers, importers and sponsors, these changes bring both clarity and complexity. Ensuring compliance with PRAC requires not only operational readiness but also legal precision, especially when the stakes involve patient safety, brand reputation and regulatory exposure. That’s where Lodestar Legal and our Med-Tech Product Recall Lawyers comes in.
Understanding the New Recall Landscape
The PRAC framework simplifies the previous system’s eight recall categories into four streamlined actions: recalls, product alerts, product corrections and quarantines. It also reduces the process from ten steps to five, speeding up how companies respond to safety concerns. Under the new regime, Sponsors must now act quickly to assess risk, notify the TGA and coordinate communications — all while maintaining accurate customer data and clear documentation.
Failure to act in line with PRAC requirements can have serious consequences, including enforcement action, product seizure and loss of market approval. With the TGA expecting faster responses and clearer reporting, legal guidance is essential to ensure every step of the recall process is handled correctly and defensibly.
Lodestar Legal: Experience You Can Trust in Product Recalls
Our Med-Tech Regulatory Lawyers we have advised clients across the med-tech and therapeutic goods sectors through several product recalls and safety alerts. We have also had experience in a number of FMCG product recalls. Our team understands the practical and legal challenges that arise when products must be withdrawn or corrected under time pressure.
We assist clients in:
- Assessing regulatory obligations under the Therapeutic Goods Act and PRAC framework.
- Preparing and reviewing recall notifications and communications with the TGA.
- Coordinating market action plans, including customer notifications and supplier engagement.
- Managing investigations and remediation, ensuring compliance and minimising reputational harm.
- Engaging with regulators to resolve post-market issues swiftly and effectively.
Our product recall experience means we don’t just interpret the law — we help clients navigate the legal minefield of product recalls with strategy, clarity and confidence.
Partnering with Lodestar Legal
As PRAC reshapes Australia’s post-market compliance landscape, medtech companies need a legal partner who can respond decisively and strategically. Lodestar Legal combines deep regulatory expertise with hands-on experience in high-stakes product recalls, helping clients protect their businesses, maintain compliance and uphold patient safety.
When every decision matters, the medtech regulatory lawyers at Lodestar Legal are your partner to navigate Australia’s evolving recall regime.
Questions? Contact us