South Africa is notorious for many “garage” and “pop-up” companies that sell medical devices, particularly in the wheelchair and mobility sector. As of next year these devices will be regulated. SIMON HAIFER reports
The Medical Control Council (MCC) of South Africa has come to realise that the business model for medical devices companies is quite different to that of medicines and, as such, is adopting a regulatory system based on best practice from other countries with similar regulatory systems.
As of 2017, medical devices are to be monitored and regulated under the “general regulations relating to medical devices and in vitro diagnostic medical devices (IVDs)”.
With many pros and cons surrounding such a regulation, there will ultimately be an increased cost to the end user as each company and, in some cases, each product needs to be registered. Fortunately, the registration costs for mobility and lower-risk equipment are less expensive and, if monitored properly, will have long-term benefits.
Companies are now required to not only register the products but also classify their own company. This means any company that intends to import, distribute and repair equipment needs to be registered as a manufacturer and therefore must pay the higher registration fees, eliminating “fly-by-nighters” who claim that distributors with large infrastructure are too expensive.
It will also allow the MCC to control these industries more effectively, motivate companies to provide better service as well as identify to end users and funders (such as medical aids, the Workmen’s Compensation Act and the Road Accident Fund) which companies stand by their products by registering as a manufacturer and providing repairs and maintenance.
This is a large undertaking and will take some time to roll out; it will require industry and the regulator to work closely together in the foreseeable future. Some common problems are very obvious. The most noticeable problem is that the South African National Accreditation System is not yet able to accredit conformity bodies so that they can audit companies to the ISO 13485, and therefore regulation may take a while to implement.
The other noticeable issue is both positive and negative in that there is now a higher barrier to entry, which improves quality and back-up, yet will also adversely affect the introduction of new and possibly beneficial products to the South African market.
So, for now, more equipment suppliers will have to register and it will be a wait-and-see policy as to the effectiveness of the new regulatory body and whether it has sufficient manpower to effectively implement and enforce the new regulations.