Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)

Guideline for Completing Medical Device Adverse Event Form for Licensed Holders (Licensee) / Holders of a Certificate Of Registration of al Medical Device (including an IVD)

This guideline provides the information to be supplied to SAHPRA when completing the form to report an adverse event for a medical device (including an IVD), it outlines the format and data requirements for reporting of an adverse event, using the  Medical Device Adverse Event Reporting Form GLF-MD-11A for medical devices (including IVDs).

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Document Number: SAHPGL-MD-11
Version: 1
Date Updated: 13/12/2024
File Type: pdf
Category: Guideline
Unit: Medical Devices