MPXV Molecular Technical Review Application

MPXV Molecular Technical Review Application

MPXV molecular test kit/s that have not been listed, registered or authorised for use in a jurisdiction recognised by the South African Health Products Regulatory Authority (SAHPRA) or that have not been pre-qualified by the World Health Organisation (WHO) will be screened against the minimal acceptable key features outlined in the Target Product Profile (TPP) contained in the MPXV Molecular Evaluation Supplier Brief.

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Document Number: MD04-2024/2025
Version: 1
Date Updated: 09/04/2025
File Type: pdf
Category: Communication to industry
Unit: Medical Devices