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Inskin Cosmedics Group fined $25,200 for alleged unlawful importation of cosmetic medical devices

17 June 2020

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.

For more information about microneedling, see Microneedling: Things to consider.

The TGA takes action against unlawful importations of cosmetic medical devices

The regulatory scheme is important to the safety of Australians. The TGA regulates medicines, medical devices and biologicals under the Act.

The TGA investigates suspected illegal activity related to therapeutic goods. A range of compliance and enforcement actions detect, deter and address unlawful trade in therapeutic goods. Where appropriate, this can involve criminal or civil court proceedings, which may result in substantial penalties, fines or imprisonment.

We encourage consumers to report illegal or questionable practices, and make advertising complaints online to the TGA.