Regulatory Requirements for Importation of Unregistered or Listed Medical Devices for Exhibition, Appraisal, Demonstration, or Training

This document provides regulatory guidance for importers, exhibitors, and other applicants seeking SAHPRA approval to import medical devices, including in vitro diagnostic medical devices (IVDs) and unlicenced listed electronic products into the Republic of South Africa for exhibition, appraisal, demonstration, or training. The Medicines and Related Substances Act No. 101 of 1965 (as amended), regulates the importation of medical devices, including in vitro diagnostic medical devices (IVDs) and unlicenced listed electronic products, into the Republic of South Africa for exhibition, appraisal, demonstrated /or training purposes.