Ionising radiation is widely used in South Africa for medical and industrial applications. It is produced by either electronic generators or radioactive materials:
- Electronic generators of ionising radiation include X-ray equipment, linear accelerators, cyclotrons and particle generators. These are used for medical, industrial, research and security applications, among others.
- Radioactive materials (radioactive sources) are also widely used in medicine, industry and research, among others.
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.
- Section 3 of the Act controls the sale, letting, use, operation, application, and installation of Group III substances. These are further regulated by Regulation R1332 of 1973.
- Section 3A of the Act controls the production, acquisition, disposal, importation, exportation, possession, use and conveyance of Group IV substances. These are further regulated by Regulations R246 and Regulation R247 of 1993.
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 (X-rays)
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:
- Email any enquiries, correspondence and completed application forms to one of the following points of contact, depending on category and/or location. Ensure that any supporting documents requested on the forms are attached and clearly labelled.
Group III hazardous substances
Installation and use of new Group III equipment:
- General X-rays: rcdealer.xrays@sahpra.org.za
- Dental X-rays: rcdent.xrays@sahpra.org.za
Installation and use of pre-owned Group III equipment:
- Gauteng, North West, Limpopo and Mpumalanga: Mqondisi.Maphophe@sahpra.org.za and Cyril.Mathiba@sahpra.org.za
- Western Cape and Northern Cape: Mqondisi.Maphophe@sahpra.org.za and Debbie.Coetzee@sahpra.org.za
- Kwazulu-Natal, Free State and Eastern Cape: Mqondisi.Maphophe@sahpra.org.za
Import and sale of new Group III equipment: Refer to Medical Devices.
Inspectorate
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.
Contact us
Email any enquiries, correspondence and completed application forms related to licencing of second-hand x-ray units to:
- Pretoria: radconpta@sahpra.org.za
- Durban: radcondbn@sahpra.org.za
- Cape Town: radconcpt@sahpra.org.za
Email any enquiries, correspondence related to inspection issues to the following points of contact:
- Head office: phineas.mahlangu@sahpra.org.za
- Pretoria: esther.matabane@sahpra.org.za
- Durban: marilda.moosa@sahpra.org.za
- Cape Town: malcolm.april@sahpra.org.za
Radionuclides
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.
Contact us
- Email any enquiries, correspondence and completed application forms to radionuclides@sahpra.org.za. Ensure that any supporting documents requested on the forms are attached and clearly labelled.
- Emergencies involving radioactive sources or material
Any incidents/accidents/overexposures involving radionuclides must be reported by phone, email or fax within 24 hours (cf Regulations 16 and 25 of Regulations R247 of 1993) to one of the following at Radiation Control:- Nico Uys – Nico.Uys@sahpra.org.za, (021) 015 5505 (for movable radioactive sources)
- Andrew Esau – Andrew.Esau@sahpra.org.za (for fixed radioactive sources)
- In the case of theft or loss of radioactive sources, or release of radioactive material in a way that it causes contamination in the public domain, contact SAPS Hawks (Directorate for priority crime investigation):
- Col. Theron – 082 463 8706, as well as one of the Radiation Control numbers above.
- Brig. Xaba (PTA) – 079 889 9582, XabaN@saps.gov.za
- Col. De Klerk (KZN) – 071 481 2982
- Col. JN Makua (DPCI-National Head Office): 082 779 8596
- For radioactive sources found at scrap metal possessing plants, contact the local SAPS Explosives Unit as well as Necsa Emergency Control Centre at 012 305 3333 (24 hours) and one of the Radiation Control numbers above.
- For fire, natural disasters and conventional accidents involving radioactive sources or materials, contact your local Disaster Management Centre (DMC) as well as one of the Radiation Control numbers above.
- For accidents/incidents during the transport of radioactive sources or materials, contact your local provincial traffic control office as well as one of the Radiation Control numbers above.
- For radioactive sources confiscated at Ports of Entry, contact the local SAPS Explosives Unit as well as one of the Radiation Control numbers above.
Non-Ionising Radiation Medical Devices (NirMed)
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
- Guidelines and Codes of Practice
Contact us
- Email any enquiries, correspondence and completed application forms related to import and sale of new Group III (X-rays only) equipment to import.xrays@sahpra.org.za.
Email any enquiries, correspondence and completed application forms related to listed electro-medical devices (excluding X-rays) to the following addresses:
- Applications: nirmed.application@sahpra.org.za
- Enquiries: nirmed.enquiry@sahpra.org.za
- Annual submissions of compliance information(ASOCI): radcon.asoci@sahpra.org.za
Communication to Industry
| Document Number | Title | Categories | Date Updated | Version | Units | File Type | Link | doc_categories_hfilter | doc_tags_hfilter |
|---|---|---|---|---|---|---|---|---|---|
| MD038 | SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746 | Communication to industry | 02/10/2023 | 1 | Medical Devices, Radiation Control | Download | communication-to-industry | medical-devices radiation-control | |
| 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 |
Radiation Control News & Updates
Regular updates regarding the Radionuclides sub-unit of Radiation Control
Key Contacts
Senior Manager : Medical Devices and Radiation Control
Dr Dimakatso Theresa Mathibe
Tel: 012 501 0358
Cell: 071 701 3787
dimakatso.mathibe@sahpra.org.za
Manager: Radiation Control
Vacant