Ophthalmic ultraviolet phototherapy solution (Cancelled from the ARTG under s.41GN1(b) and (f))
Product name
Ophthalmic ultraviolet phototherapy solution
Sponsor
ARTG
262531
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN1(b) and (f)
Grounds for regulatory action
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.