Lately, South Africa’s regulatory framework for electromagnetic medical devices has come under considerable pressure. In this article the legislative framework and regulatory infrastructure are scrutinized, by looking at how the legislature has given form to protective measures against ionizing radiation.
Although the Hazardous Substances Act provides for effective protection against radiation, poor administration led to insufficient staffing levels, uncertainty about Regulations and licensing conditions and therefore undermines a sound radiation protection infrastructure. The legal basis of enforcing licensing conditions through a website without proper consultation with interested and affected parties is questionable and ineffective in controlling radiation levels.
Effective and legal radiation control is possible by activating the National Advisory Committee on Electronic Products provided for in Regulation R326 published in 1979, but never implemented.
The possible impact of annual quality assurance tests currently enforced through licensing conditions on the radiation dose of the population is not cost effective as new training and accreditation structures had to be created. The fact that generally more than 80% of overexposures are caused by human error is a clear indication that training of the daily users of X-ray equipment should be emphasized and not the training and accreditation of the technicians responsible for a single quality assurance test per year.
Constructive engagement with the professional bodies involved in the medical use of X-rays through a National Advisory Committee on Electronic Products may be a cost effective solution for lowering radiation dose to the population.

Protection, Act, Law, Regulations, Licencing conditions