The Therapeutic Goods Administration (TGA) has issued two infringement notices totalling $25,200 to Sydney-based company Inskin Cosmedics Group Pty Ltd for alleged breaches of the Therapeutic Goods Act 1989 (the Act).
It is alleged the company imported Dermapen unbranded micro-needle cartridges that were not, at the time of the relevant importation, included in the Australian Register of Therapeutic Goods (ARTG). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia.
Cosmetic medical devices can come with serious risks
Consumers should be aware that the use of cosmetic medical devices that are not entered in the ARTG, including microneedling devices, can come with serious risks.
Microneedling is a procedure where small needles embedded in a device puncture or scrape the skin. It is generally performed to treat skin conditions such as acne scars. Risks of microneedling include skin redness and ultraviolet (UV) sensitivity after the procedure, and in some cases, there is a risk of scarring or infection. The risk is greater if microneedling is done without the supervision of a health professional or with inadequate hygiene controls.
