All manufacturers, importers and sellers of medical devices in South Africa are required to be registered
with the South African Health Products Regulatory Authority (SAHPRA). Renewal of a SAHPRA license
will require applicants to be certified to ISO 13485.
We have successfully assisted a manufacturer of medical devices to achieve ISO 13485 certification
through TUV Rheinland, and later to successfully transition to ISO 13485:2016.
SAHPRA have issued “Guidelines for recall / withdrawal, adverse events & post-marketing vigilance
reporting of medical devices and IVDs”, which includes follow up actions.
We have developed a Standard Operating Procedure for incorporating these guidelines in the QMS,
which can be adapted for a client’s needs.
Retention of CE marking will require QMS transition from compliance with MDD to compliance with MDR.
We have assisted a manufacturer of medical devices with CE marking to transition to the main
differences between MDD and MDR, which the notified bodies will be wanting to see on their next
surveillance audit.
Contact us for more information or assistance in transition from MDD to MDR.
