Promedical Equipment Pty Ltd

Regulatory activities for this sponsor.

1 result(s) found, displaying 1 to 1

2019-nCov Ab Test (Colloidal Gold) (Cancelled from the ARTG under s.41GN(1)(b))

16 September 2020

Cancellation or suspension

Regulatory action due to The certifications made by the sponsor under section 41FD of the Therapeutic Goods Act 1989 in relation to the inclusion of the kind of device in the ARTG are incorrect in a material particular and the sponsor failed to comply with the conditions of inclusion stipulated under paragraph 41FN., effective 16/09/2020