Mpox Diagnostic Test Kit Regulatory Requirements

Mpox Diagnostic Test Kit Regulatory Requirements

The first human case of Mpox was reported in the Democratic Republic of Congo; the outbreak has since spread to other countries, including South Africa. South Africa is currently experiencing an outbreak of Mpox clade II. Mpox (previously known as Monkeypox) is an infectious disease caused by the Mpox virus. This viral infection can be spread between people, mainly through close contact.

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Document Number: MD03-2024/2025
Version: 1
Date Updated: 09/04/2025
File Type: pdf
Category: Communication to industry
Unit: Medical Devices