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.
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