Last December 9, the South African Department of Health issued the Regulation no.1515 in order to define regulatory requirements for Medical Devices and IVDDs, with a particular reference to public tenders.

The keypoints of the Regulation no.1515 are the following:

– in order to participate to the public tenders, the Medical Devices must be registered to the South African Medicines Control Council (MCC). The registration of Medical Devices that are not intended for public tenders is not mandatory, but the Competent Authority can force it.

– The registration of Importers and Distributors that intend to market Medical Devices in South Africa is compulsory as well. The licensing requirements for Importers and Distributors are unchanged.

Moreover, the Regulation foresees a transition period in order to manage the registration of the relevant devices and companies.

 

For further information:

http://www.gov.za/sites/www.gov.za/files/40480_gon1515.pdf