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Optimed Pty Ltd

Regulatory activities for this sponsor.

Type

Date

51 result(s) found, displaying 51 to 51

  • Ophthalmic ultraviolet phototherapy solution (Cancelled from the ARTG under s.41GN1(b) and (f))

    Cancellation or suspension
    Regulatory action due to 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., effective 18/11/2016