OMC’S Overview and Key Changes (The “New Pathway”)
South Africa has transitioned from the old Medicine Control Council (MCC) system to a new, risk-based framework under SAHPRA. This new pathway, which became fully effective, is based on ISO 13485:2016 and aligns more closely with international best practices (like the EU MDR/IVDR and IMDRF guidelines). The most critical point is that SAHPRA does not accept direct applications from foreign manufacturers. You must work through a local South African Responsible Person (LRP). SAHPRA’s New Path...
