Point Of Care Diagnostics Australia Pty Ltd

Regulatory action due to The Device was suspended from the Register under section 41GA of the Act, and the period of suspension, applied under subsection 41GC(3) has expired before the suspension was revoked under section 41GD of the Act.The information submitted in response to the suspension is insufficient to remove the grounds for cancellation and fulfil the requirements of the suspension being revoked., effective 20/04/2020

Regulatory action due to Under subsection 41GA(1)(b); it is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 18/10/2019