Guideline for Medical Device Adverse Event Reporting

This guideline provides a reference document detailing the regulatory requirements for reporting of an adverse event for a medical device (including an IVD) in South Africa and describes the information to be supplied to the South African Health Products Regulatory Authority (SAHPRA). This guideline is intended to holder of a medical device establishment licence (referred to as the “licensee)” and the holder of a certificate of Registration (HCR) in the reporting of an adverse event associated with the use of a medical device (including an IVD). This guideline describes and classifies the types of adverse events that are to be reported to SAHPRA, it also entails information on how to submit an adverse event report associated with medical devices to SAHPRA as well as the time-lines applicable for the report and in which cases is the licensee / HCR or user exempted from submitting a report. This guideline provides examples of reportable adverse events and a decision-tree to assist the licensee / HCR or user when determining if an adverse event is to be reported to SAHPRA.