In December 2016 the Pretoria High Court ruled that one cannot avoid regulatory oversight by the Medicines Control Council (MCC) by declaring that a health-related product is a medical device and not a medicine. That is a determination which the MCC must make.

In Omegalabs (Pty) Ltd v The Medicines Control Council and Others,

The Department of Health in South Africa has recognised that one of the reasons for the failure to achieve ‘Health for All’ as envisioned by the Alma Ata Declaration is the failure to address health systems effectively. In line with their intention to prioritise access to medicines and vaccines the department launched self-service medicine-dispensing machines