When the amendments to the Medicines and Related Substances Act come into operation, it will result in significant changes to the regulatory regime currently in place.
According to guidelines issued by the department of health and Medicines Control Council (MCC), the new regulations will apply to the manufacturing, importing, exporting and distribution of medium- and high-risk medical devices.
Although proposed licensing requirements will apply to local companies, foreign manufacturers exporting to South Africa will also be affected. “As it stands, the MCC is only responsible for managing the introduction of medicines in all forms into the local supply chain,” says Graham Anderson, Profmed’s CEO and principal office.
Imported devices will also come under scrutiny
He says if the new rules come into play, all medical devices brought into the country will also be properly regulated. “The definition of medical devices in the proposals i