The South African government will soon enforce the registration of domestic medical devices and its manufacturers, importers and distributors first proposed in 2015 in amendments to the Medicines and Related Substances Act. CEO and Principal Officer at Profmed, Graham Anderson, explains how when the Act comes into operation it will result in significant changes to the regulatory regime currently in place.
According to guidelines issued by the National Department of Health (NDoH) and Medicines Control Council (MCC), the new regulations will apply to the manufacturing, importing, exporting and distribution of medium- and high-risk medical devices.
Although proposed licensing requirements will apply to local companies, foreign manufacturers exporting to South Africa will also be affected.
As it stands the MCC is only responsible for managing the introduction of medicines in all forms into the local supply chain. If the new rules come into play all medical devices brought into the country will also be properly regulated. The definition of medical devices in the proposals is quite broad and will cover everything from disposable syringes to MRI scanners.
The need for regulation
Profmed has supported an initiative to regulate the operation of medical devices in the country for years. As the law currently stands, anybody can bring any type of machine into South Africa and no legal requirement exists on reporting on its purpose or cost or efficacy. There is thus no record or proof of what the machine intends to treat, whether it actually works and what the costs associated with bringing it into operation and maintaining it. That also means the owners of these machines can charge whatever they want, whether the treatment is effective or not.
The lack of transparency in this regard has placed a great burden on both medical schemes and its members over the years, as it has been impossible to sufficiently cater for cost and purpose of some investigations and procedures.
As a consequence there are instances where both individual and organisation have been left out of pocket and without the knowledge of the specific benefit derived from using a specific device.
A new regulatory authority
The new guidelines stipulate that the MCC will be replaced by a new regulatory authority, called the South African Health Products Regulatory Agency (SAHPRA).
The components of the proposed system include a four-tier, risk-based classification system, as well as requirements for obtaining device licenses for manufacturers, importers and distributors.
It also specifies that full technical documentation on devices need to be submitted to the regulator on request, as well as all required information pertaining to importation, transportation, storage, distribution, marketing and sales.
According to the MCC, domestic manufacturers and distributors will have to apply for local registration as soon as the regulations are enacted. Foreign operators and importers will also need to get their paperwork in order by then.
SAHPRA is seen by the industry as an upgraded version of the MCC. It has been described as similar in model to the Food and Drug Administration (FDA) in the US that it will be more independent than the MCC. It will fall outside of the NDoH and funded only partly by government with additional funds raised by way of fees charged and services rendered within its regulatory ambit.
More transparency for consumers
The most important benefits of the new regulatory framework for medical schemes and its members will be that it will close the door for fly-by-night operators and the potential for them to sell half-truths to the South African consumer as research into and technical information of these devices will be available for public consumption.
In addition, the medical scheme fraternity will have a better idea of the costs associated with all medical machinery and equipment.
Of course, if the new authority is up and running, it will also allow for medicines to be approved and be made available at a faster rate and at a more competitive rate.
SAHPRA will come into existence only once the amendments have been enacted. Although still very uncertain, it does seem that there is a push to implement and start giving practical effect to the Amendments during 2017. Profmed thinks it conceivable that the Authority will be brought into action sometime this year.