Ionising radiation is widely used in South Africa for medical and industrial applications. It is produced by either electronic generators or radioactive materials:
Radiation Control regulates all activities involving electronic generators of ionising radiation as well as radioactive sources used outside the nuclear fuel cycle. The aim is to protect patients, radiation workers, the public and the environment against over-exposure to ionising radiation, without limiting its beneficial use.
Radiation Control receives its regulatory mandate through the Hazardous Substances Act (15 of 1973) (the Act), which classifies electronic generators of ionising radiation as Group III hazardous substances, and radioactive sources as Group IV hazardous substances.
Device control is mandated by the Schedule for Listed Electronic Products Regulation R1302 of 1991.
Application forms, codes of practice, guidelines and other useful documents related to Radiation Control can be downloaded via these links:
Electronic generators of ionising radiation include cyclotrons, particle generators and a wide range of X-ray devices used in medicine and industry. Medical uses range from linear accelerators, interventional radiography, computed tomography and mammography to general radiography and dental X-rays. Industrial uses include industrial radiography, mining, security, veterinary medicine, and research, mortuary and forensic applications. Application forms, codes of practice, guidelines and other useful documents related to electronic generators of radiation (Group III hazardous substances) can be downloaded via these links:
Group III hazardous substances
Installation and use of new Group III equipment:
Installation and use of pre-owned Group III equipment:
Import and sale of new Group III equipment: Refer to Medical Devices.
Radiation Control Inspectorate is mandated by Hazardous Substances Act No 15 of 1973 to inspect Group I, II, III and IV hazardous substances.
An inspector may at all reasonable times enter any premises on or in which any substance suspected to be a grouped hazardous substance is or is suspected to be manufactured, packed, marked, labelled, kept, stored, conveyed, sold, used, applied, administered, or dumped.
An inspector may inspect or search such premises, or examine, or extract, take and remove samples of, any substance (other than a Group III or a Group IV hazardous substance) found in or upon such premises, or any appliance or other object so found which is or is suspected to be used, or to be destined or intended for use in connection with the manufacture, packing, marking, labelling, storage, conveyance, use, application or administration of a grouped hazardous substance, or in connection with any other operation or activity with any grouped hazardous substance, or open any package suspected to contain a grouped hazardous substance.
An inspector may demand any information regarding any such substance, appliance or object from any person in whose possession or charge it is or from the owner or person in charge of such premises; weigh, count, measure, mark or seal any such substance, appliance or object or its package, or lock, secure, seal or close any door or opening giving access to it; examine or make copies of, or take extracts from, any book, statement or other document found in or upon such premises and which refers or is suspected to refer to such substance, appliance or object.
An inspector may at any time place an embargo for an indefinite or prescribed period on any grouped hazardous substance, appliance, vehicle, or other object which is concerned in or is on reasonable grounds believed by him/her to be concerned in a contravention or suspected contravention of any provision of this Act, irrespective of where or in whose possession he/she finds such substance, appliance, vehicle or object.
Email any enquiries, correspondence and completed application forms related to licencing of second-hand x-ray units to:
Email any enquiries, correspondence related to inspection issues to the following points of contact:
Radionuclides (radioactive sources) are widely used for medical as well as research and industrial applications. The main medical applications are radiotherapy (radiation therapy) and nuclear medicine. Industrial uses include irradiators, industrial radiography, well logging, automated process control devices, soil moisture gauges and thickness gauges. In South Africa, all radionuclides with an activity above 4 kBq (4 000 becquerel) must be licensed.
Radiation Control has been regulating the import, manufacture, sale and use of all Group III electronic products included in the Schedule of Listed Electronic Products (Regulations R1302 of 1991). In terms of the Hazardous Substances Act 15 of 1973, a licence is required for the import of any product on the Schedule (with the exception of the products in sections 1(8), 5(7), 5(8) and 5(9)). The holder of an import licence must be permanently resident in South Africa and is required to comply with all relevant legal provisions and licence conditions. In order to be licensed for import, all such listed medical devices must comply with the European Union Medical Device Directive (or its successors). A licence is also required in terms of the same Act for the use of certain categories of listed electronic products, namely magnetic resonance imaging (MRI) systems and Class 3B and Class 4 lasers.
Application forms, codes of practice, guidelines and other useful documents related to listed electronic products (Group III hazardous substances) can be downloaded via these links:
Import and Manufacture
Email any enquiries, correspondence and completed application forms related to listed electro-medical devices (excluding X-rays) to the following addresses:
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|Communication to Industry – Importing and operating unlicensed dental X-ray equipment||Communication to industry||16/02/2023||1||Radiation Control||Download||communication-to-industry||radiation-control|
Senior Manager : Medical Devices and Radiation Control
Dr Dimakatso Theresa Mathibe
Tel: 012 501 0358
Cell: 071 701 3787
Manager: Radiation Control
Ms Kgomotso Hendrietta Tlhapi
Tel: 012 501 5420
Cell: 064 909 9513