Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Indiba Australia Pty Ltd - Skin contouring system generator, radio-frequency (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Skin contouring system generator, radio-frequency
Sponsor
Date action takes effect
Compliance action
Medical device cancellation - certain devices within an entry
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act.
Grounds for regulatory action
The sponsor did not provide sufficient 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, and the certifications made are incorrect, or are no longer correct, in a material particular. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude any accessories / handpieces of the device used for the aesthetic and functional procedures that claim to correct and restore the optimal structure of the vagina and surrounding tissues (vaginal rejuvenation).