Optimed Pty Ltd

Regulatory action due to The sponsor failed to provide information requested under section 41JA of the Act and therefore failed to comply with an automatic condition of inclusion under section 41FN(3)(c) of the Act., effective 16/06/2020

Regulatory action due to As the sponsor did not provide sufficient information to substantiate that the appropriate conformity assessment procedures have been applied to the kind of device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the inclusion of the device in the ARTG were correct, in a material particular., effective 18/11/2016