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Medical Device Adverse Event Reporting Form

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13 Dec Medical Device Adverse Event Reporting Form

Posted at 11:04h in by

This document is intended to assist the 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 enables the reporter to provide SAHPRA with relevant and concise information related to the adverse event.

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Document Number: GLF-MD-11A
Version: 1
Date Updated: 13/12/2024
File Type: docx
Category: Application forms, Form
Unit: Medical Devices