Update on ISO 13485 Certification Requirements in South Africa

In August 2022, the South African Health Products Regulatory Authority (SAHPRA) released Communication to Stakeholders MD032, outlining new requirements for Conformity Assessment Bodies (CABs) operating in South Africa. Specifically, CABs must be accredited either by SANAS (South African National Accreditation System) or recognised under the International Accreditation Forum (IAF) in order to operate in the country.

We’re pleased to confirm that, since 2023, BSI has been recognised by SAHPRA as a Conformity Assessment Body authorised to conduct ISO 13485 assessments in South Africa. This recognition is based on BSI’s accreditation by both UKAS (United Kingdom Accreditation Service) and RvA (Dutch Accreditation Council, under which BSI holds full scope across all technical areas.

Effective 01 June 2025, manufacturers and importers/distributors of medical devices and IVDs intending to submit a renewal or new application will be required to provide a valid ISO 13485 certificate from a recognised and SAHPRA-registered Conformity Assessment Body.

This is a significant regulatory milestone for manufacturers looking to place medical devices and IVDs on the South African market.

BSI is proud to support this process through internationally recognised ISO 13485 certification services. If you have questions about ISO 13485 certification, our team is here to help.

Yours sincerely,

Angela Claire Logue
Head of Global Oversights, Regulatory Services - Notified Body, BSI