Medical Device Registration Into South Africa
Medical devices are regulated by the South African Medicines Control Council (MCC).
Currently, only electro-medical devices and single-use or disposal devices are regulated in South Africa, and licensing is typically based
on recent CE certification. Licenses are typically issued within three to five days of receiving correct documentation.
The license are renewed annually. The manufacturer has to appoint the authorized representative.
ADDITIONAL INFORMATION: A new regulatory body overseeing the registration of all medical devices, the South African Health
Products Regulatory Agency (SAHPRA), is expected to be instated shortly.
New Medical Device Registration Requirements Issued in South Africa:
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 Africas 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.
Initial take aways 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.
Let We Can assist you in evaluating the South African medical device regulatory framework as it applies to your device(s).
Our worldwide network of in-house consultants, industry contacts, and regulatory sources allows us to provide in-depth and accurate analysis of medical device markets, including South Africa.
Our Regulatory Pathway report service covers the following issues regarding the South African market:
Regulatory Background for the Directorate of Radiation Control and Medicines Control Council.
Product Assessment and Classification.
In-Country Representation in South Africa.
Labeling and Language Requirements.
Costs and Timeframes.
Regulatory Roadmap for South Africa.