Biosoft Pty Ltd

Regulatory action due to As the sponsor did not provide information to substantiate compliance with the essential principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a).As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5)., effective 04/02/2014