The Department of Health is the entity in charge of public health in South Africa through managing the national health system (NHS). Although medical devices are largely unregulated in South Africa, the Department of Health does regulate electromedical devices and radiation-emitting devices through the Hazardous Substances Act, No. 15 of 1973.
Importers or manufacturers of electromedical or radiation-emitting devices are required to obtain a license from the Department of Health, Directorate: Radiation Control as per Section 4 (1)(b) of the Hazardous Substances Act, 1973.
Some of the most important regulations for medical devices in South Africa are:
- Schedule of Listed Electronic Products - Regulation No. R. 1302,14 June 1991
- South Africa Government Gazette No. 34463 - Draft Regulations
- Hazardous Substances Act No. 15 of 1973 - regulations regarding electromedical devices
- Requirements with regard to the application for a licence to import, manufacture or fully refurbish any listed electromedical device
A full list of South Africa's Department of Health regulations can be found here.
- Website: http://www.health.gov.za/