Dale Howes of Wits University gave a fascinating presentation on the role of custom designed implants for treating patients with maxilla-facial cancer, while CapeRay’s CEO Kit Vaughan spoke about the company’s innovative Aceso dual-modality imaging system that has been designed to detect cancer early in women with dense breast tissue. Richard Gordon of the Medical Research Council – South Africa’s equivalent of the National Institutes of Health in the USA – spoke about funding opportunities for the development of innovative medical devices, while Simone Rudolph-Shortt considered some of the regulatory challenges faced by local manufacturers.
Simone highlighted a recent announcement by the South African government – the Medicines Control Council (MCC) of the Department of Health – that requires all local manufacturers of medical devices to apply for a licence between 1 August 2016 and 31 January 2017. The new regulations apply to the manufacture, importation, exportation and distribution of medium- and high-risk devices (categorized as B, C and D). Low-risk or Class A devices are exempt from the regulations, with the MCC providing clear guidelines on the classification of devices and in vitro diagnostics (IVDs).
The first requirement for companies is to demonstrate proof of registration with one or more of the regulators in the following geographic markets: Australia; Brazil; Canada; European Competent Authority (CE Mark); Japan; and the USA: either 510(k) predicate device or pre-market authorization (PMA). The new guidelines also specify that manufacturers must be able to submit full technical documentation on their devices to the MCC on request.
According to Brian Goemans, CapeRay’s regulatory affairs engineer, companies need to appoint an Authorized Representative who is a natural person and “responsible to the regulator for all activities including importation, transportation, storage, distribution, marketing and sales.” CapeRay’s only concern is that the regulator – the MCC – has a poor track record in the efficient regulation of the pharmaceutical industry.