The TGA broke news today that a microneedling device that has now been officially cancelled from the Australian market.
As per the announcement, the TGA is warning Australians about undergoing procedures using unapproved medical devices, following their decision to cancel an electronic microneedling device from the Australian Register of Therapeutic Goods last week.
The product, which remains undisclosed, was cancelled following the failure of the sponsor to provide information about the safety and efficacy of the product as required under section 41JA of the Therapeutic Goods Act (the Act). According to TGA guidelines, cancelled products cannot be imported, manufactured or exported by the sponsor, unless otherwise exempt or approved under the Act. Here in Australia, many microneedling devices are regulated as medical devices.
Also in its announcement, the TGA has taken the opportunity to share with consumers some of the risks associated with microneedling procedures.
“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. A microneedling device or procedure is generally higher risk if it:
- claims to treat any skin condition, such as acne scarring, and/or
- claims to penetrate the skin
Health professionals who specialise in treating skin conditions (dermatologists) are well suited to performing microneedling procedures and providing advice about your skin,” reads the TGA press announcement.
The news has already been supported and shared by industry bodies such as the The Australasian College of Dermatologists. For more breaking news and industry updates, be sure to subscribe to as-they-happen story notifications via our homepage, or by clicking below to subscribe to our newsletter.