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.

“It appears that the South African Department of Health eventually wants all devices to be registered through a formal registration system, but is starting slowly with devices that are sold in public tenders,” says Brian Goemans, Emergo Senior Consultant and Country Manager for South Africa.

Initial takeaways regarding the new regulations include:

• Only devices registered with the MCC may participate in public tenders
• Only companies licensed with the MCC may import devices into South Africa
• There are transitional arrangements for unlicensed manufacturers, importers and distributors, as well as for unregistered medical devices and IVDs

Licensing requirements for local manufacturers, distributors and importers remain in effect under the new regulations. Unlicensed companies seeking to import devices into the country must submit license applications to the MCC by late January 2017.

Key caveat: Emergo consultants are closely analyzing the text of the new regulations to determine compliance implications and requirements for medical device companies interested in the South African market. We will add to and change the information above as we learn more details regarding the new rules.