Medical device registration in South Africa
South Africa, despite having a relatively minimal health infrastructure, is the wealthiest African nation and is also a leading supplier of medical devices to other African nations
How to register for your medical devicein South Africa
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.
South Africa medical device regulations 2017The 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.
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.
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.
South Africa medical device regulations 2017The 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.
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.
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
