Therapeutic Goods Administration Australia
IPL Systems Australia only sells ipl machines with a TGA registration
Australia’s booming laser and IPL treatment industry is being fuelled by cheap, ready-to-use machines from overseas.
IPL machines could be imported from overseas for as little as $8000. They are never registered, as required, by the Therapeutic Goods Administration, which regulates the supply of therapeutic and medical devices.
Because there is such intense competition, people are looking for very, very cheap machines and providing cheap treatments and promoting it for inappropriate treatments.
A recent survey of laser and IPL devices found that fewer than half were actually registered on the Australian Register of Therapeutic Goods, which lists equipment that can legally be imported, supplied or exported.
The illegal importation or supply of medical devices that are not registered attracts penalties of up to 12 months’ jail and an $110,000 fine for individuals and a $550,000 fine for companies.
MEDICAL CE CERTIFICATION
In Europe, medical devices require CE certification. Comprehensive documentation to demonstrate the safety and efficacy of the device is required to obtain medical CE certification.
A Medical CE can only be issued by approved authorities; these authorities are worldwide, independent, accredited organizations
The MediSyst hair removal and photo rejuvenation devices possess a Medical CE mark. Our devices were able to pass the stringent requirements of a Medical CE due to the high standards adhered to by the manufacturing company
For a company to produce a high quality product, they are required to adhere to the ISO 9001 and ISO 13485 standards. The implementation of these strict rules provides a level of traceability for the IPL machines IPL Systems Australia sells. A high level of quality control is implemented on every component of our MediSyst devices throughout the manufacturing process, which is followed by an array of stringent tests.
The implementation of these rules does have an impact on the sale price, as IPL Systems Australia would rather provide a guarantee of the utmost in terms of quality.






