The South African Health Products Regulatory Authority (SAHPRA) stated that a Conformity Assessment Body will only be recognized by SAHPRA for compliance with the South African regulations in respect of regulatory and any additional South African requirements as determined by the SAHPRA, within the scope of their accreditation (as outlined in MD032: ISO13485 Conformity Assessment Body Communication).
All CABs need to ensure that if they are not accredited by SANAS, they are accredited by signatory members of the International Accreditation Forum Multilateral Arrangement (IAF MLA). In order for them to be recognized by SAHPRA, they need to complete the Conformity of assessment body Doc and CAB requirement checklist. We encourage members to ensure that their CABs complete the documentation required to be recognised by SAHPRA.
