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InSkin Cosmedics Group pays $37,800 in penalties for alleged supply and advertising of unapproved dermapen device
InSkin Cosmedics Group Pty Ltd has paid penalties of $37,800 in regards to the alleged supply and advertising of the Dermapen 4, a medical device that was not included on the Australian Register of Therapeutic Goods (ARTG) at the relevant times.
The TGA issued three infringement notices for the following alleged contraventions of the Therapeutic Goods Act 1989:
- Section 41MIB(1)(a)(iii) - supply of Dermapen 4 (medical device) not included in the ARTG. Two infringement notices issued for offences on 22 February 2019 and 17 May 2019.
- Section 42DLB(1)(9) - advertising Dermapen 4, a medical device not included in the ARTG.
Australia's therapeutic goods legislation prohibits the import, export, manufacture, supply and advertising of therapeutic goods for human use that are not included in the ARTG or otherwise the subject of an exemption, approval or authority.
Be aware and report illegal activity to the TGA
Consumers should be aware that unapproved medicines and medical devices can carry serious risks.