Aesthetic Medicine
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Kick-starting
skin’s revitalisation the
process Investing in aesthetic medicine equipment is a must for any salon or clinic looking to increase their service offerings, and create a more holistic approach to anti-ageing skincare.
A
s the costs for aesthetic medicine equipment may be high, there are some very important factors to consider before you purchase a device. Says Tashlyn Louis, clinical trainer at Radiant Healthcare: “First and foremost, ensure the equipment that you are investing in, is in demand in your clinic. Once you have made a decision – the next step is to ensure that you will get the desired results. This is especially important as clients will be paying more for these services, thus increasing their expectations.” Louis notes that any piece of equipment that emits radiation, or that carries a current, needs to be registered with the Department of Health: Radiation Control. She continues: “Official distributors always comply with this requirement, ensuring that all devices imported by these distributors are legal in South Africa. “CE marking is a certification mark that indicates conformity with the health, safety, and online @ probeauty.co.za
environmental protection standards for products sold within the European Economic Area (EEA). It’s important to note that CE Medical certification is a legal requirement in this country. If a laser does not have this (including a medical conformity number), it is not allowed to be in South Africa and the Department of Health can take legal actions, such as closing your salon.” These rules and regulations can be found in the Schedule of Listed Electronic Products Hazardous Substances Act, No. 15 of 1973 Regulation No. R.1302, 14 June 1991. Another document from the Department of Radiation Control (i.e. Requirements for the safe use of Class 3B and Class 4 Lasers or Laser systems) outlines the exact requirements needed for safety in South Africa. These requirements follow the exact same steps needed by the European Economic Area. If a company is unable to produce this certificate, they have sold you a device illegally. Naomi Olivier of Hitech Lasers adds: “While FDA (US Food and
Drug Administration) approval is not a requirement in South Africa, it can be seen as a further safety and production quality feature. The FDA system was designed to protect US citizens against unsafe medical devices and therefore cannot guarantee the safety of a medical device if manufactured outside the US. ‘FDA approved’ means that the agency has determined that the ‘benefits of the product outweigh the known risks for the intended use’. “If any salon owners are thinking of purchasing preowned devices, they should note that only devices which have already previously been licensed in South Africa and which have subsequently been distributed and used in this country, may be resold within South Africa. The importation of a pre-owned device is strictly prohibited except if such a device adheres to all the above requirements. If a device that has been refurbished in South Africa is bought, it should adhere to these regulations and prove that the refurbishment was done by a CE qualified technician.”
