Guideline for Medical Device Certificate of Free Sale

This guideline is intended to provide guidance on obtaining a Certificate of Free Sale, which serves as confirmation that the listed medical devices, including in vitro diagnostic medical devices (IVDs), are legally sold or distributed in the market in South Africa, freely without restriction. It outlines the procedural steps to ensure consistency, transparency, and regulatory compliance in supporting the export of safe, effective, and quality-assured medical devices from South Africa. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and performance of medical devices and IVDs. The authority reserves the right to request additional information to establish the safety, quality, and performance of a medical device and IVD in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used but should be scientifically and technically justified. The Authority is committed to ensuring that all registered medical devices and IVDs will meet the requirements of the Essential Principles relating to quality, safety, and performance. Applicants must adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.

Application Form for Certificate of Free Sale for Medical Devices:

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