Yes, South Africa's SAHPRA may accept US FDA approval as a reference for the registration of medical devices and diagnostics. SAHPRA recognizes certain international regulatory approvals, including those from the US FDA, as part of its regulatory processes.
However, similar to CE marking approval, having US FDA approval does not automatically guarantee approval in South Africa. Manufacturers are still required to submit a registration application to SAHPRA and provide relevant documentation to demonstrate compliance with South African regulatory requirements. This may include additional testing, clinical data, or other information specific to the South African market.
It's important for manufacturers to consult with SAHPRA or regulatory experts to understand the specific requirements and process for using US FDA approval as a reference for registration in South Africa.
