TFS Manufacturing Pty Ltd and Minister for Health

This matter concerned an application by TFS Manufacturing Pty Ltd for review of a decision by a delegate of the Minister for Health, which affirmed the cancellation of a medical device's entry on the Australian Register of Therapeutic Goods. The cancellation was based on TFS's alleged failure to comply with a condition requiring it to have sufficient information to substantiate compliance with essential principles 2, 6, and 14 of the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth). The core dispute revolved around whether TFS had indeed failed to meet this condition and, if so, whether the discretion to cancel the device's registration should have been exercised.

The court was required to determine two primary issues. Firstly, whether TFS had refused or failed to comply with the condition that it possess sufficient information to satisfactorily establish compliance with essential principles 2, 6, and 14 at all times while the device was listed on the Register. Secondly, if a failure to comply was established, whether the Secretary should have exercised the discretion under section 41GN of the Act to cancel the device's entry on the Register. The relevant period for assessing compliance was identified as the time the device was included on the Register, prior to its cancellation on 5 November 2014.

The court affirmed the cancellation decision. It found that TFS had not demonstrated that it had sufficient information available to substantiate compliance with the specified essential principles during the relevant period. While acknowledging TFS's submissions that the focus should be on the safety and efficacy of the device and that cancellation should be a last resort, the court concluded that suspension was no longer a practical option given the circumstances. The court reasoned that suspension, if it had been a viable option at the time of the decision, would have been limited in duration and TFS had not shown steps to rectify the grounds for cancellation within such a period. Consequently, the court decided to affirm the cancellation decision.