South Africa Medical Device Regulations

All documents listed below are available from the South African Department of Health. Electromedical devices fall under the scope of the Hazardous Substances Act, No. 15 of 1973.

Major Regulations

DocumentLanguageNumberPublished
Classification of Medical Devices and IVDsen ver 1 07/2016
Draft Regulations for Medical Devices and IVDs Vol. 601; No. 3899014 July 2015
Hazardous Substances Act - regulations regarding electromedical devices.en No. 15 of 197303/1993
Medical Devices and IVDs Essential Principles of Safety & Performanceen ver 107/2016
South Africa Government Gazette - Draft Regulations en No. 37579 04/2014
South Africa Government Gazette- Draft Regulationsen No. 34463 07/2011

General Guidance Documents

DocumentLanguageNumberPublished
General Informaiton Medical Devices and IVDsen 8.0109/2014
Medical Devices and IVDs Essential Principlesen 8.0209/2014

Specific Guidance Documents

DocumentLanguageNumberPublished
Guideline For A Licence To Manufacture, Import, Export Or Distribute Medical Devices & IVDSen ver 107/2016
Requirements with regard to the application for a licence to import, manufacture or fully refurbish any listed electromedical deviceen Act 15 of 19731973

Forms and Applications

DocumentLanguageNumberPublished
Application for a License to Conduct Clinical Trials on a Locally Manufactured Listed Electromedical Producten 41BM-1(CLINLOC) 09/2014
Application for a License to Import a Listed Electromedical Product for Clinical Trialsen 41BM-1(CLINIMP) 09/2014
Application for a License to Import a New Listed Electromedical Producten 41BM-1(IMP) 09/2014
Application for a License to Manufacture or Fully Refurbish a Listed Electromedical Deviceen 41BM-1(MAN) 09/2014
License Application (.XLS)en ver 107/2016

Additional Information

DocumentLanguageNumberPublished
Licensed Electromedical Devices - List of licensed devices up to May 2011en ZA-00105/2011