South Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016)

South Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016)

“…’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

By |2019-09-12T16:39:17+00:00December 9th, 2016|Global Regulatory Resource|0 Comments