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Medical Device Regulations

South Africa does not have a comprehensive system of medical device regulation. However, the market is very sophisticated and it is strongly advisable that products are either CE or FDA approved.
 

The exception is electro-medical devices (or radiation emitting devices): the Directorate: Radiation Control of the South African Department of Health is responsible for regulatory control over the sale and use of the attached schedule of listed electronic products. FDA approved electro-medical products without the CE mark will not be accepted. A license must be obtained from the Directorate: Radiation Control, by any dealer wishing to sell a listed electro-medical product in the South African market.
 
That being said, the South African Department of Health is currently in the process of drafting the necessary policy documents, which cover the regulation of ALL devices, and has indicated that this will come into effect in 2014.
 
It is therefore essential that the process for device regulation be followed from the word go! For additional information register on this site or contact md2m directly. Below is the regulatory process required for CE Certification. FDA and other regulatory certificates follow a slightly different route not detailed here.
 
The chart below is from Emergo Group.    
 
 CE marking emergo