South Africa Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for South Africa.

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Major Regulations
Document Number Published Language
Log in Regulations Related to Medical Devices and In Vitro Diagnostic Medical Devices English
Log in Hazardous Substances Act No. 15 of 1973 15 1973 English
Log in Medical Devices and IVDs Essential Principles of Safety and Performance English
Log in Post Marketing Vigilance Reporting for Medical Devices and IVDs English
Log in Medicines and Related Substances Control Act No. 101 of 1965 101 1965 English
General Guidance Documents
Document Number Published Language
Log in Guideline on the Classification of Medical Devices and IVDs English
Specific Guidance Documents
Document Number Published Language
Log in Medical Device Quality Manual English
Log in Guideline For A Licence To Manufacture, Import, Export Or Distribute Medical Devices & IVDS ver 1 07/2016 English
Log in Schedule of Listed Electronic Products No. R.1302 06/1991 English