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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 applicant was a healthcare company which applied for a declaratory order that their product (a skin preparation called Dermalex),…
The ‘Procedural regulations pertaining to the functioning of the office of health standards compliance and handling of complaints by the ombud’ (the procedural regulations) were brought into force on 13 October 2016. The Office of Health Standards Compliance (The OHSC), was established by the National Health Act. It is responsible for the monitoring and enforcement of compliance by health establishments, including private hospitals, with norms and standards prescribed by the Minister of Health…