Beauty devices in Australia have lived in an area of regulatory uncertainty. Some businesses have taken advantage of this and some of those have felt the wrath of the TGA.
The TGA has now provided clear guidance on what they require for regulatory compliance.
Manufacturers of radiating medical devices must comply with Essential Principle 11. Examples of radiating medical devices include:
- medical lasers,
- phototherapy devices,
- X-ray machines; and
- dental curing lamps.
Radiating beauty therapy products such as:
- laser combs,
- dermal abrasion devices (or dermal abrasion products that apply energy to the patient),
- skin rejuvenation devices (or skin rejuvenation products that apply energy to the patient); and
- hair removal products that apply energy to the patient.
are not medical devices unless:
- therapeutic claims are made or
the product is:
- surgically invasive
- invasive via a body orifice
DTS has Medical Device Consultants that can assist with any guidance you may require.