Medical CE – Radiant Health
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
While this marking is not required by South Africa Laws, there are regulations to which all laser, and radiation emitting devices need to comply with.
These rules and regulations can be found in 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 (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 – meaning that if a device has achieved CE Marking – we can rest assured that it complies with the laws of the land.
Why does CE Medical certification actually matter?
Part of the path to obtaining a CE Medical Marking for a device includes the need for Clinical Trials.
The reason for this is having proof that a machine does, what is says it can do. Take for instance Fat Freezing Cryolipolysis devices. There are Clinical Trials related to the amount of vacuum suction needed to have a safe treatment – these clinical trials take into account the need to the treated area away from the organs, how big the area is to be treated. The clinical trials also ensures that the correct temperatures are used.
When machines do not have this CE Medical marking, a lack of results for the patients are the least of your worries. Illegal devices can results in burns, tissue necrosis, and organ damage.
Another example is Plasmatechnology. When you see a CE Medical conformity on this device, it means the device uses pure Plasma. Some devices on the market state they use Plasma, when in actual fact there are a form of Fractionated Radio frequency. The problem, of course, being that the device is an uncontrolled form of heat which may result in excessive tissue damage.
It is worth noting: the HSPCSA has a regulation preventing any non-medical professional to do non-surgical Blepharoplasty (upper eyelid treatment).
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