Australians are being warned about undergoing procedures using unapproved medical devices, following the TGA's decision to cancel an electronic microneedling device from the Australian Register of Therapeutic Goods on 4 November 2019.
The product was cancelled following the failure of the sponsor to provide information to the Secretary about the safety and efficacy of the product as required under section 41JA of the Therapeutic Goods Act (the Act).
Cancelled products cannot be imported, manufactured or exported by the sponsor, unless otherwise exempt or approved under the Act.
Microneedling is a procedure where small needles embedded in a device puncture or scrape the skin. This is believed to treat skin conditions such as acne scars by promoting the release of collagen.
Many microneedling devices are regulated as medical devices.
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.
More information about microneedling can be found on our web page Microneedling: Things to consider.
Report illegal or questionable practices
The TGA oversees the regulation of therapeutic goods used in Australia, whether produced in Australia or elsewhere. The TGA implements a range of enforcement remedies to address illegal supply of unapproved therapeutic goods, including seizing and destroying illegal medicines and medical devices, and criminal or civil court proceedings, which can result in substantial fines or imprisonment.
You should report illegal or questionable practices, including suspected counterfeit medicines and medical devices, to the TGA. Advertising complaints can also be made online.
14 November 2019 edited to add:
Details of the ARTG Entry that was cancelled on 4 November 2019
Product: Dermapen 4 - Electronic cosmetic micro-needling handpiece
Sponsor: McEvoy Legal