Guideline for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices

This document serves as a guideline to assist applicants to comply with the requirements for a Site Master File (SMF) regarding the wholesaling of medical devices (including In vitro diagnostics (IVDs)). The South African Health Products Regulatory Authority (SAHPRA) is committed to ensure that all premises where medical devices are procured and stored for the purposes of selling to retailers and end users are of the required quality, safety and performance, and that wholesaling activities are conducted comply with statutory requirements and complies with acceptable quality assurance principles and good wholesale practices as determined by the Authority.