Getting medical devices on the South African market has become a hot topic lately. This article is the first of a series of articles on this topic and gives a high-level overview of some of the regulatory aspects concerning medical device market access, as well as some implications and considerations to take into account before deciding to sell in the Republic. According to a market analysis report by Fitch Solutions, it is reported that approximately 90% of medical devices in South Africa are imported. This over-reliance on foreign manufacturing means that the majority of local companies are involved in distribution activities. In this article, all that applies to medical devices is also applicable to in vitro diagnostic devices.
When it comes to regulating medical devices, a reliance model is used as part of the framework. In this model, the regulator (SAHPRA), acknowledges other international regulatory product approvals such as US FDA and EU CE, to name a few. For example, if a local company wants to distribute a medical device that has obtained FDA approval, the regulator will recognize this approval when evaluating the license application. One of the implications of the regulatory reliance model is that proudly South African companies that are involved in manufacturing are required to get product certification before being issued a license from the regulator (this can prove to be very costly).
So, where do you start? According to the regulator, no medical device can be sold without the manufacturer, distributor, or wholesaler of that device obtaining an Establishment License by the authority. In other words, local companies (establishments) are required to obtain a license to legally sell their product(s). It is very important to note that the regulator does not (yet) register medical devices. At the time of writing, the regulator states that the registration process is still under development.
There are three types of Establishment Licenses that you can apply for:
License to Distribute if you import/export medical devices and sell them;
License to Wholesale if you purchase medical devices from distributors and manufacturers and sell them to retailers;
License to Manufacture if you perform any of the following operations with regards to a medical device: design, purchasing of material, specification development, production, fabrication, assembly, processing, reprocessing, releasing, packaging, repackaging, labeling, and refurbishing;
Once you’ve determined which license applies to your organization, you are ready to complete the application and send it for evaluation approval. You should take note that the application process consists of multiple steps and conditions that will be discussed in subsequent parts of this article series. Upon approval, your establishment is now registered in the authority’s database of registered establishments and you can sell your medical devices. Licenses have a validity period of 5 years and are subject to an annual retention fee.
As of March 2020, the regulator introduced a new requirement whereby all establishments, upon renewal of their licenses, will have to present an ISO 13485 certificate issued by an accredited conformity assessment body. This certificate demonstrates compliance with the internationally recognized standard for Quality Management Systems for Medical Devices. Therefore, as a local company registering for a SAHPRA license, you should take into account the planning, resources, and financial implications of certifying your organization for ISO 13485 when renewing your Establishment Li
In PART 2 of the series, we give an overview of how medical devices are classified according to their risk.