News

NEW MEDICAL ADVISOR JOINS APS THERAPY

The well-know Springbok rugby player, Dr Uli Schmidt, has joined the APS Therapy team as from the 1st of February 2002. We at APS internationally would like to welcome Uli to our team and hope that he will have the same effect on APS as he did with the Springbok rugby team.

Welcome Uli !

MEDCERT APPOINTED AS NEW NOTIFIED BODY

MedCert has been appointed as the new notified body of APS Technologies Ltd as from 1st February 2002.

 Beware of illegal Electro-medical products

The APS range of products need no introduction in South Africa. 

The company has come a long way since the launch of its first product in 1992 and has spent vast amounts on research and development. The product has either been patented or have patents pending in 38 countries and have received numerous awards world-wide.

The success of APS has recently led to many new products seeing the light and entering the Electro-medical market. Unfortunately, some of these products are marketed illegally in South Africa and the general public are therefor misled and deceived by unethical and unscrupulous marketers of these products.

Products are sold to the public on the assumption that it is "the same as APS, just much cheaper".

 Without spending any funds on research and development, they merely piggy-back on the credibility and research of APS. Furthermore, they either ignore the regulations of the Department of Health, or alternatively falsely imply that they meet the requirements laid down by law. In South Africa (under the Hazardous Substances Act, Act 15 of 1973), a listed Electro-medical product has to comply with internationally recognised requirements for safety and performance.

The standard (minimum) requirements with regard to the issuing of a licence for sale are: The 510(k) or Pre-Market Approval response letter in which the FDA grants approval for a particular model to be marketed in the USA; The CE Declaration of Conformity made by the manufacturer for a particular model in terms of either the Medical Devices Directive 93/42/EEC or the Active Implantable Medical Devices Directive 90/385/EEC. In terms of the EC directive, any such product has to bear the CE marking of conformity for medical devices when they are placed on the market. Apart from the CE marking, the identification number of the notified body responsible for the implementation of the procedures in accordance with the Directive 93/42/EEC, must be displayed. The notified body is an independent certification organisation that performs formal audits of products and quality systems specified in the Directive.

It is heartening to know that the Department of Health is willing to act in the interest of the public at large by enforcing the laws laid down. According to a spokesman, companies trading illegally can be forced to withdraw all their products and may by written notice direct the company to deal with or dispose of the said units in such manner as the Director General may determine.

A spokesman of APS says they have always welcomed competition because it's healthy and at the end of the day the consumer benefits. However, competition has to be fair and products marketed on an ethical basis so as not to mislead the public. APS have embarked on a campaign, which warns the public:

 "If it does not say APS, it is not APS." 

APS have obviously lost a great deal of sales to these illegal products that sold for a fraction of the price and merely piggy-backed on the good name of APS. The company is however positive that it has regained much of its lost market share and remains dedicated in serving the public through its innovative products and research. To date more than 40 000 people world-wide have benefited from the APS products, hence their slogan "for a better quality of life."

The public is warned against buying illegal or inferior products and should ascertain whether the product is licensed and should insist on seeing research based on the specific product being offered to them. Far too often marketers try to sell products based on the technology of other products.

 At the time of going to press, the above information was confirmed as being correct by the Department of Health (021) 948-6162.

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