“…’manufacture’ means operations that include the design, purchasing of material, specification development, production, fabrication, assembly, processing, reprocessing, releasing, packaging, repackaging, labelling, and refurbishing of a medical device or IVD, as the case may be, and includes putting a collection of medical devices or IVDs, and possibly other products, together for a medical purpose in accordance with quality assurance and related controls;’…”
https://www.emergobyul.com/sites/default/files/south-africa-regulations-medical-devices-ivds.pdf