For the time being, only electronic medical devices are regulated in South Africa. Licensing from the Directorate of Radiation Control is required in order to import electronic medical devices into the country. Market authorization for these devices in South Africa requires prior EU approval.
Let Emergo assist you in evaluating the South African medical device regulatory framework as it applies to your device(s)
Emergo'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:
- Regulatory Background for the Directorate of Radiation Control
- Product Assessment
- In-Country Representation Issues in South Africa
- License Requirements
- Costs and Timeframes
- Regulatory Roadmap for South Africa
Please contact us for more information about our Regulatory Overview Report for South Africa.