Mask, surgical, single use (Cancellation from the ARTG under subsections 41GM(1), 41GM(2) and 41GN(1) of the Act)
Product name
Mask, surgical, single use
Sponsor
ARTG details
358410
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsections 41GM(1), 41GM(2) and 41GN(1) of the Act
Grounds for regulatory action
The Sponsor has failed to comply with the notice under section 41JA of the Act to provide the requested information within a further 10 working days.
The Sponsor has failed to comply with one or more conditions to which the inclusion of the Device in the ARTG is subject, in particular, they have failed to comply with a notice under subsection 41FN(2) of the Act, which is to provide samples for TGA testing within a further 10 working days.