Medical Devices Reliance Guideline

This guideline outlines the principles and procedures for reliance-based review in both premarketing and post-marketing regulatory activities for medical devices, including in vitro diagnostics (IVDs). It defines the Regulatory Reliance pathways that the South African Health Products Regulatory Authority (SAHPRA) will use in making regulatory decisions regarding establishment licensing, product registration, clinical trial approvals, ISO 13485 audits, post-marketing and market surveillance, and other functions such as importation for donations, exhibitions, and appraisals. This document reflects SAHPRA’s current approach to ensuring the safety, quality, and performance of medical devices and IVDs. SAHPRA reserves the right to request additional information to confirm the safety, quality, and performance of a medical device, based on the knowledge available at the time of evaluation. The Authority is committed to ensuring that all registered and listed medical devices, including IVDs, meet required standards of quality, safety, and performance. Applicants are expected to comply with all administrative requirements to prevent delays in processing and evaluation.