South Africa’s New Regulations

Posted on: August 26th, 2016 by admin 2 Comments

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For the past two days the South African Medical Device Industry Association (SAMED) has been holding its annual conference in Johannesburg. The programme theme was “Partnering for Patients” and various sessions were organized, including: policy related to procurement strategies; pre-tender interactions; wastage and corruption in centralized procurement; single use devices and their re-use; application of health technology assessment; medical device registries; and innovation in locally manufactured devices. Given that over 90% of medical devices are imported to South Africa, there are significant opportunities for local manufacturers, especially if the government implements preferential procurement policies that are used elsewhere in the world such as in Brazil and India.

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.

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2 Responses

  1. “CapeRay’s only concern is that the regulator – the MCC – has a poor track record in the efficient regulation of the pharmaceutical industry.”
    Hopefully this will in no way affect your 2D/US dual-modality combo machine?
    Ian

  2. Kit Vaughan says:

    Thanks for the feedback, Ian. No, I don’t believe the MCC should have a negative impact on our machine, unless of course they take forever to issue the necessary licence. However, there’s another part of the Department of Health – the Radiation Control Division – that issues the Licence to Operate a new system, and we have dealt with them in the past when we ran our clinical trials.
    Kit