All healthcare products must be registered with the South African Health Products Regulatory Authority (SAHPRA). Only authorized representatives in South Africa can apply for registration.   

All entities involved in the manufacture, distribution, import, and export of healthcare products must be licensed by SAHPRA.   

There are no licenses, approvals, or fees required for advertising medical devices and medicines. However, medicines that contain a substance classified under schedules 2–6 can only be advertised to medical practitioners.   

Some medical devices must be sterile to reduce the risk of infection. They should be terminally sterilized to a Sterility Assurance Level (SAL) of at least 10-6.   

Medical devices must include information about handling, storage, warnings, restrictions, precautions, and operating instructions.   

Medical devices are classified into different classes, such as Class B x-ray films, Class C blood bags, Class D biological heart valves, and Class D implantable pacemakers.   

SAHPRA provides guidelines on topics such as the International Metric System (SI), licensing of medical device establishments, co-packaging of medicines, and fixed dose combination products.