EMERGO SUMMARY OF KEY POINTS:

• Updates to the Australian TGA’s medical device recall process will come into effect in January 2018.
• The updated TGA recall process includes guidelines for determining recall versus non-recall actions.
• TGA registrants should take advantage of a “familiarization period” between now and the recall updates’ effective date of January 15, 2018.

Australian medical device regulators will implement changes to their recall requirements for medical devices and other healthcare products in January 2018.

Australia’s Therapeutic Goods Administration (TGA) has published a new version of its Uniform Recall Procedure for Therapeutic Goods (URPTG) so that medical device market registrants may familiarize themselves with updated requirements before updates take effect on January 15, 2018.

How the TGA medical device recall system works

TGA’s device recall process entails several key steps: determining whether recall or non-recall actions are appropriate, undertaking a determined recall or non-recall action, and identifying issues that warrant recall or non-recall actions.

First, a recall of a device sold on the Australian market is necessary when that device does not comply with specified standards, or does not meet legislative or manufacturing requirements, and that non-compliance leads to issues regarding safety, performance, presentation or quality.

Non-recall actions, on the other hand, are applicable in cases where a device does comply with all relevant standards and requirements and does not present any safety, performance or quality issues. Non-recall actions include safety alerts, product notifications, quarantines (which may result in full recall actions), and product withdrawals (for example, removing a prior model of a device from the market when a new model is commercialized).

Next, the sponsor responsible for the device in question must undertake the recall or non-recall action. The sponsor must follow TGA uniform procedures for immediate or other recalls, including obtaining agreement from the regulator before initiating the action. Such undertakings must also involve all stakeholders involved in the recall: sponsors, manufacturers, distributors and exporters, healthcare professionals, consumers and regulators.

In terms of identifying issues that may require recall or non-recall actions, TGA states that any organization or individual involved in a device’s supply chain may do so:

• Manufacturers, via implementation of quality management systems
• Australian sponsors, via adverse event reports or complaints
• TGA, via post-market monitoring and compliance oversight
• Other regulators, which may notify TGA of device-related issues in their markets
• Third-party audits and inspections

Related Australian medical device regulatory information:

• Australian TGA medical device registration consulting
• Australian TGA Sponsor in-country representation
• TGA medical device vigilance reporting support
• Video overview: Australia’s medical device approval process
• Whitepaper: Medical device registration in Australia and New Zealand