Spotlight on recent regulatory changes in South Africa
£50.00
Understand South Africa’s evolving medical device framework and its implications for registration, compliance, and market entry
English
This article provides a comprehensive overview of recent regulatory developments in South Africa pertaining to medical devices and in vitro diagnostics, as announced by the South African Health Products Regulatory Authority (SAHPRA). One key update involves the phased implementation of mandatory ISO 13485:2016 certification requirements for manufacturers and distributors seeking to renew or amend their medical device establishment licences. SAHPRA has also published several guidelines introducing detailed procedures for clinical investigations and evaluations, defining post-market surveillance and post-market clinical follow-up expectations, and clarifying the regulatory framework for artificial intelligence/machine learning-enabled medical devices. Furthermore, a new guideline on the preparation of a Site Master File for wholesalers of medical devices has been drafted to outline the structure and content required to support establishment licence applications and renewals. SAHPRA has also released a draft guideline on borderline products to clarify regulatory pathways for products straddling different legislative frameworks, with stakeholder input invited by 1 December 2025. It has also clarified its legal stance on the reprocessing of single-use devices. Collectively, these updates signify SAHPRA’s ongoing efforts to align with international best practices and are part of SAHPRA’s broader efforts to strengthen safety, quality, and performance standards in the medical device sector.
Specification: 14 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2025 issue of the Journal of Medical Device Regulation.
