The South African government has formed an independent, state-owned agency to oversee new medical device and pharmaceutical regulatory systems being developed in the country. The South African Health Products Regulatory Authority (SAHPRA), which has been launched officially in June 2017, will be built up over the next few years, and will regulate both the medicines and the medical devices (including IVDs).
Overview of the procedure
The process of implementation has a limited timeframe; starting in June and ending on the 24th of August 2017. All companies who are active in the market must submit a license which acts as an official document confirming they are trading legally and may continue trading, until the deadline.. After this period, a company may only start to sell once the license is issued. As part of the application, a company must list all devices that it manufactures, imports, exports or distributes. Registration of devices will follow in 2018.
An Authorized Representative must be appointed:, 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 compliance with the regulations.
There are two types of licenses:
- Manufacturer license (manufacture, label, service, import, export)
- Distributor license (import, distribute, export)
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 license, but having one may be useful in facilitating the import of the devices.
In the application for a license for Class B, C, and D devices, the following requirements apply:
- Class B – provides 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, USA, European Union, Brazil, Canada and/or Japan. The registration holder must also hold a copy of the technical file.
Obelis can help you to obtain a Free Sale Certificate and to obtain a proof of market approval in the European Union in order to sell your devices in South Africa.
If you wish to know more about SAHPRA, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have, will help you provide proof of market approval in Europe, and will gladly assist you in safeguarding your products’ compliance.