TFS Manufacturing Pty Limited and Minister for Health

This matter concerned an application by TFS Manufacturing Pty Limited for review of a decision by a delegate of the Minister for Health to cancel the registration of a medical device from 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 available to substantiate compliance with essential principles at all times while the device was registered. The Tribunal was tasked with determining the correct or preferable decision, considering evidence that might include events occurring after the initial cancellation decision.

The central legal issue before the Tribunal was whether the discretion to cancel the registration of a medical device contained a temporal element, and consequently, whether the Tribunal could consider evidence of TFS's subsequent and ongoing compliance with essential principles when making its determination. TFS argued that the nature of the essential principles in question meant that compliance was not strictly time-sensitive, and therefore, the Tribunal's review should not be limited to the period the device was on the Register.

The Tribunal concluded that the statutory provisions governing the cancellation of registration imposed a clear temporal limitation. Specifically, section 41FN(3)(a) of the Therapeutic Goods Act 1989 (Cth) requires compliance "at all times while the inclusion in the Register has effect." This wording indicated that the decision to cancel registration was based on the state of facts at a particular point in time – namely, during the period the device was included on the Register. The Tribunal found that the provisions did not concern direct compliance with the essential principles themselves, but rather the condition of having sufficient information to substantiate that compliance throughout the registration period. Therefore, the Tribunal was not persuaded by TFS's argument that the discretion was not temporally limited and that evidence of subsequent compliance was relevant to the decision under review.