25 Jan Guideline on Medical Device Quality Manual
Posted at 12:53h
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This guideline is intended to provide recommendations to applicants wishing to submit applications for a licence to manufacture, import, distribute and export a medical device, including In Vitro diagnostics medical devices (IVDs). It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and performance of medical devices and IVDs.
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Document Number:
SAHPGL-MD-05
Version:
4
Date Updated:
14/03/2023
File Type:
pdf
Category:
Guideline