December 14, 2016 by
EMERGO SUMMARY OF KEY POINTS:
- New South African registration requirements for medical devices and IVDs appear to have taken immediate effect from December 9, 2016.
- Registration will initially be required only for devices participating in South Africa’s public tender system.
- The Medicines Control Council (MCC) will continue requiring licensing of local manufacturers, distributors and importers in order to import devices into South Africa.
The South African Department of Health has issued new regulatory requirements covering both medical devices and in vitro diagnostic (IVD) devices, according to Emergo consultants in Cape Town.
The regulations are based heavily on guidance and principles of the International Medical Device Regulators Forum (IMDRF) and its predecessor organization, the Global Harmonization Task Force (GHTF); the new rules appear to take effect immediately, but Emergo offices in South Africa and the US are working to verify implementation and compliance details.
Based on an initial analysis of the new regulations, registration with the South African Medicines Control Council or MCC is for now required only for devices whose manufacturers and sponsors participate in the country’s public tender system. However, the MCC has the authority to impose registration requirements at its discretion for devices not participating in public tenders, as well.