Medical equipment – other than electro medical devices – including disposable or single use devices, is not regulated in South Africa. There is currently no comprehensive system of medical device regulation.  However, it is strongly advisable that the product be FDA approved or even better, carry the CE mark. Potential importers must apply for a license for each model of electro medical devices or appoint a local authorized representative to apply for the license. Please note that FDA-approved only electro medical products are no longer accepted for import in South Africa. The Directorate recognizes EC certification only.

The South Africa Department of Health will establish the new regulator that will oversee the registration of both the medicines and the medical devices. Although it will function as an independent and an autonomous body, it will still function under the authority of the Minister of Health. Plans to establish the long-awaited SA Health Product Regulatory Authority (SAHPRA), which will replace the Medicines Control Council (MCC) are progressing well and the new regulator is expected to start operating in April 2012.  



Our country specific (*) regulatory services in South Africa include:

Medical Device specific regulation strategy reports, Medical Device Registration with South African MOH, local Representative and certification holder for Medical Device manufacturers, MCC Technical documents preparation and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.
 
GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in South Africa!

(*) South African Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service.