High Tech Medical Pty Ltd

Regulatory action due to Pursuant to section 41GA(1)(b) of the Act, the Secretary has suspended the device as it is likely there are grounds for cancelling the device from the Register under Division 2 (other than under paragraph 41GL(a) or (d) or section 41GM).

The Secretary is satisfied there are grounds for cancelling the device from the Register under subsection 41GN(1)(b) because the Sponsor has failed to comply with the conditions of inclusion set out under subsections 41FN(3)(b) and (c).