For the time being, only electronic medical devices are regulated in South Africa. Licensing from the Directorate of Radiation Control are required in order to import electronic medical devices into the country. Market authorization for these devices in South Africa requires prior EU approval.
Emergo Group’s worldwide network of in-house consultants, industry contacts and regulatory sources allows us to provide in-depth and accurate analysis of medical device markets including South Africa. Our Global Regulatory Overview report service covers the following issues regarding the South African market: