Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance
On March 5, 2025, the Australian Therapeutic Goods Administration (TGA) introduced new guidance ‘Procedures for Recalls, Product Alerts and Product Corrections’ (PRAC) for handling recalls and corrective actions on therapeutic products, including Medical Devices. This guide replaces the previous ‘Uniform Recall Procedure for Therapeutic Goods’ (URPTG), simplifying and strengthening the post-marketing vigilance process for greater clarity and efficiency.
The PRAC specifically targets foreign manufacturer sponsors, i.e. those who hold the marketing authorisation for the medical device through registration in the Australian Register of Therapeutic Goods (ARTG).
Reporting adverse events relating to a medical device in the Australian market must comply with the Therapeutic Goods Act and the Therapeutic Goods (Medical Devices) Regulations. Post-market monitoring by the competent authorities aims to protect the health and safety of patients, healthcare professionals and users by reducing the likelihood of such events recurring.
From URPTG to PRAC: What Changes?
One of the most significant changes concerns the classification of market actions: whereas the URPTG had eight separate categories, the PRAC has simplified them into four, making them clearer and easier to understand.
- Recall: withdrawal of the product from the market for safety reasons.
- Product Alert: a communication informing stakeholders of product safety updates.
- Product Correction: modification or update of a product without withdrawal from the market.
- Quarantine: temporary interruption of distribution pending further verification.
The main changes can be summarised as follows:
- Updated terminology: elimination of the distinction between ‘recall’ and ‘non-recall’ in favour of a single category called ‘market actions’.
- Streamlined procedure: reduction of steps in the recall management process from 10 to 5.
- Greater clarity: improved documentation with explanatory tables and diagrams.
- Simplified definitions: simplified definitions of class and level of market shares.
- New communication management processes: TGA now directly distributes sponsor-approved letters to customers. Furthermore, the TGA will no longer verify the accuracy of customer lists, making sponsors responsible for providing accurate information to avoid delays.
- Removal of information on TGA legislative powers related to recalls: this information will be updated and placed as separate guidelines on the TGA website.
In the event of a significant and imminent risk to life and public health, tampering or problems with radiopharmaceuticals, blood, tissue or clinical trials, sponsors must order customers to quarantine the affected products and notify the parties involved immediately, before contacting the TGA for further guidance.
The PRAC retains the reforms introduced in the last version of the URPTG published in March 2024, which include more flexible reporting requirements, greater transparency and new, more user-friendly templates.
The Five Phases of PRAC
- Problem assessment: collection of data on the products involved and risk analysis.
- Notification to the TGA: sending the required documentation through the dedicated portal.
- Review and approval: the TGA evaluates the case and sends an authorisation letter before sponsors can contact clients.
- Initiation of Market Action: customer communications and response management.
- Process closure: periodic reports and formal conclusion of the procedure.
Classification of Market Shares
Market shares are divided into three classes according to risk level:
- Class I: critical situations requiring immediate action.
- Class II: moderate risks requiring urgent corrective action.
- Class III: problems with low-security impact.
Depending on the mode of action, actions may include recalls, product corrections, alerts or quarantines (temporary suspensions).
With this revision, the TGA aims to ensure greater speed and transparency in the recall of therapeutic products, improving public health protection and facilitating compliance for practitioners.
>>> For all medical device regulatory compliance management processes in Australia, Thema experts are ready to offer the necessary support.
03/19/2025
