25 Jan Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices and In Vitro diagnostics (IVDs). It represents the South African Health Products Regulatory Authority current thinking on the safety, quality and performance of medical devices and IVDs.
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Document Number:
SAHPGL-MD-06
Version:
3
Date Updated:
23/03/2023
File Type:
pdf
Category:
Guideline