Dermapen 4, the award-winning microneedling device made in Australia, has lost its TGA approval – albeit only temporarily.
According to the TGA, the device’s listing on the Australian Register of Therapeutic Goods has been cancelled due to “the failure of the sponsor [McEvoy Legal] to provide information to the Secretary about the safety and efficacy of the product as required under section 41JA of the Therapeutic Goods Act”.
This means that the Dermapen 4, like all “cancelled products” cannot be imported, manufactured or exported by the sponsor, unless otherwise exempt or approved under the Act.
DermapenWorld founder and CEO Stene Marshall has however reassured Dermapen4 owners that the cancellation of the device, which was launched just 18 months ago, is a “temporary situation”.
“The TGA has withdrawn the Dermapen 4 due to a dispute over the classification process,” he explained.
“This is a paperwork issue rather than an issue with the device itself.
“The way they [the TGA] are classifying devices is completely inconsistent and while we disagree with them, we are taking a sensible legal approach that we are confident will see the situation resolved in the very near future.”
Marshall said that “given the time frame we anticipate the issues being resolved in”, DermapenWorld has not sent any formal notices about the TGA listing to Dermapen owners.
“At this time, clinics using the Dermapen should have no concerns in continuing to use it given the issues are legal,” he said.
“Dermapen has been used consistently in the marketplace and around the world for almost a decade without a single safety or health concern.
“We can’t emphasise this enough: the device itself is not in question.
“We (Dermapen World and our distributors Inskin Cosmedics) do however appreciate that situations like this can cause stress and concern for all Dermapen 4 owners and users to whom we extend our deepest apologies for any inconvenience.”
He added that the “huge inconsistencies with the TGA’s current classifications of microneedling devices were likely to be resolved with the new regulatory process’s due to come into effect in mid-2020 ‒ and make listings “much clearer” to the aesthetics industry.
According to Marshall, the Dermapen 4, which won the main award in the medical and scientific category at last year’s Australian International Design Awards, offers numerous advantages over other micro-needling devices, including:
- Ergonomic design (lightweight and durable hand-piece with easy-grip mechanism)
• New scar treatment setting
• A 16-needle cartridge design
• AOVN 4 Technology (advanced oscillating vertical needle technology for increased speed, precision and safety)
• Built-in RFID needle cartridge
• ACM (Anti-Contamination Management system to ensure there is “no fluid back flow, no cross-contamination and no drag”)
• Bluetooth enabled connectivity
• Digital display with one-touch integrated procedural settings (to manage depth, speed and treatment settings).
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