Yes, South Africa's SAHPRA does accept CE marking approval as a reference for the registration of medical devices and diagnostics. The acceptance of CE marking as a reference is part of the regulatory harmonization efforts between South Africa and the European Union (EU).
However, while the CE marking approval can be used as a reference, it does not guarantee automatic approval in South Africa. SAHPRA still requires manufacturers to submit a registration application and 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.
In summary, while CE marking approval can streamline the registration process in South Africa, manufacturers are still required to comply with SAHPRA's regulations and submit a complete registration application for approval.
