Alert for June 1 deadline for ISO 13485 certification to access South African market

The South African Health Products Regulatory Authority (SAHPRA) has given plenty of notice to industry over the last several years regarding their new requirement for ISO 13485 certification.

From June 1 2025, manufacturers and distributors (importers) of medical devices shall be certified to ISO 13485:2016 by a CAB recognised by SAHPRA.

SAHPRA will verify evidence of compliance to this requirement following a phased approach, as described in their recent communication to industry.

For more information from SAHPRA see: ISO-13485-Certificate-Communication_Signed19.pdf

Visit  ISO 13485 | Quality Management Systems for Medical Devices for more information on how Intertek can support your certification needs.