EMERGO SUMMARY OF KEY POINTS:

• The South African government has formed the South African Health Products Regulatory Authority (SAHPRA) to oversee the country’s medical device and drug markets.
• SAHPRA is based on elements of South Africa’s Medicines Control Council (MCC).
• The initial period of implementing the new South African medical device regulatory system ends in August 2017.

The South African government has formed a new agency to oversee new medical device and pharmaceutical regulatory systems being developed in the country.

As of June 2017, the South African Health Products Regulatory Authority (SAHPRA) has come into being, although its full scope of activities will only be implemented over the next few years. The origins of SAHPRA are from the Medicines Control Council (MCC), and SAHPRA will regulate both medicines and devices (including IVDs). Combination devices that have in the past been regulated as medicines will in future fall under device regulations. SAHPRA will be an independent state-owned entity, which is to be built up over the next few years.

The process of implementation started in Feb 2017 with registration of medical device companies. This initial period ends on 24 August 2017. Within this period all companies who are active in the market and submit a licence are considered to be trading legally and may continue trading. After this period, a company may only start trading once a licence is issued. As part of the application, a company must list all devices that it manufacturers, imports, exports or distributes. Registration of devices will follow in 2018.

There are two types of licences: manufacturer (manufacture, label, service, import, export) or distributor (import, distribute, export).  A distributor licence would only apply where the device when imported bears the name and address of the registration holder (in South Africa). Addition of a label with the registration licence holder name is classified as a manufacturing activity.

Listing of medical devices

South Africa has a risk based classification scheme, based on the GHTF scheme. Companies who handle Class A devices are exempt from the requirement to apply for a licence, but having a licence may be useful in facilitating import of the devices.

In the application for licence for Class B,C, and D devices, the following requirements apply:

• Class B – provide a free sales certificate from the country of origin.
• Class C and D – provide proof of market approval in one of the following markets: Australia, US, European Union, Brazil, Canada and/or Japan. The registration holder must also hold a copy of the technical file.

The application includes a declaration that the essential elements of a quality management system are in place. Within the next few years, this will change to a formal requirement for a QMS certified to ISO 13485.

Registration of devices

One year after the initial licencing period ends, Class D devices will be called up for registration, and one year later, Class C devices will be called up for registration.

There may be only one registration holder of a device, so if there is more than one distributor, one must be the registration holder as manufacturer or distributor, and the others would be wholesalers, supplied by the registration holder.

One further noteworthy aspect of the regulations is that an Authorised Representative must be appointed, and must be a natural person based in South Africa. One representative is required for each site where the company carries out its business. The representative is responsible for adherence to the regulations.

Brian Goemans is Senior Consultant and Country Manager for Emergo's South Africa business.

More South African medical device market resources:

• South Africa medical device regulatory strategy report
• Collected South African medical device regulations