The Medicines and Related Substances Act, 1965 allows the South Africa Health Products Authority (SAHPRA) to call up both medicines and medical devices for South African registration.  Unlike medicines (which must be registered), SAHPRA has yet to call up medical devices for registration.  This means that no medical device currently manufactured, imported, distributed, or sold in South Africa is registered with SAHPRA. 

SAHPRA instead relies on the registration of medium to high risk devices in one of SAHPRA’s recognised jurisdictions as proof of the device’s safety and efficacy.  And only licensed medical device establishments can manufacture, import, distribute or sell medical devices in South Africa.   

While this reliance model allows local medical device establishments to manufacture, import and sell medical devices without inundating SAHPRA with registration applications, SAHPRA’s decision not to test and evaluate products locally forces South African medical device establishes to register their medical devices overseas before they can be sold in South Africa. 

In May 2024 however, SAHPRA issued a communication to industry, indicating its intention to conduct a voluntary feasibility study for medical device registration.  The study aims to validate SAHPRA’s proposed registration process for medical devices intended for human use. 

Draft guidelines for medical device registration are already available on SAHPRA’s website.  They indicate that registration requirements will differ based on the classification of the device’s risk (which is in turn based on the device’s intended use, degree of invasiveness, and duration of use) as well as whether the device is already registered in a recognised jurisdiction.

While SAHPRA has not yet called up any medical devices for registration, the roll out of a feasibility study and publication of draft guidelines hints at SAHPRA’s intention to call up medical devices for registration after the feasibility study has been done.  SAHPRA has therefore encouraged medical device establishment licence holders to familiarise themselves with the draft guidelines.  Those involved in the manufacture, import, distribution, and sale of medical devices should make their views known to SAHPRA in regard to the feasibility study and the draft guidelines.