Care Quip

Regulatory action due to Information supplied to the TGA was insufficient to substantial compliance with Conformity Assessment procedures (s.41FN 3(a)) and the Essential Principles (s.41FN3(b)). Additionally, the sponsor did not comply with conditions of inclusion (s.41FN 3(c)) and false or misleading information was provided at the time of application (s.41FD (d))., effective 05/06/2019