It’s been a long time coming, but they’re finally here. Justin Malherbe, at law firm Norton Rose Fulbright South Africa writes that the long-awaited ‘Regulations relating to Medical Devices and in vitro diagnostic medical devices (IVDs)’ were published by the Minister of Health in the Government Gazette on 9 December 2016. These regulations are now in force.
Malherbe writes: “This latest development follows years of uncertainty surrounding the regulation of medical devices in SA. Unlike the supply and distribution of medicines which are strictly controlled and monitored by the Medicines Control Council (MCC), medical devices have gone largely unregulated in the past. This can be partially ascribed to gaps and inconsistencies in the healthcare legislation, coupled with capacity constraints in the existing regulatory system.
“While capacity constraints remain, a dedicated regulatory framework for medical devices is now a step closer with the new regulations. These follow on from various draft sets of regulations that were published previously for comment.
“The new regulations are aimed at regulating ‘medical devices’ as defined in the Medicines and Related Substances Act 101 of 1965, (referred to as ‘the Act’). This covers all devices that are intended for human or animal use that do not achieve their primary intended action by pharmacological, immunological or metabolic means in or on the body. The regulations also apply to in vitro diagnostic devices (IVDs) which are succinctly defined as medical devices intended for in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.
“The current situation with regards to medical devices is altered by the new regulations in the following ways:
“Importers, manufacturers, wholesalers and distributors of medical devices are required to obtain a licence from the regulatory authority to engage in their respective activities. This entails the appointment of a natural person resident in SA as the authorised representative who will be responsible for complying with the regulatory requirements including requirements of licensing and registration. Licences are valid for 5 years and are renewable on application and payment of the prescribed fee. An annual continued registration fee is also payable.
“Medical devices and IVDs must now be registered. The application for registration can be made by any person residing and doing business in SA. As with the licencing requirements, an authorised representative must be designated in the application together with providing particulars of the prospective holder of the certificate of registration. The device or IVD itself must comply with quality, safety and performance standards including those imposed under any approved quality system. A declaration of conformity to those quality standards must be provided, along with any applicable assessment certificate issued by a conformity assessment body accredited by the regulator to conduct pre-market inspection and testing of medical devices. Further practical requirements are detailed in Regulation 8.
“Medical devices and IVDs are now classified according to their risk to patients and healthcare users or to public health. They may be classified in four classes, from Class A (low risk) to D (high risk). The risk of a particular device is determined by the regulator according to certain criteria, taking into account the design and intended use of the device.
“Clinical trials and investigations of unregistered medical devices or of new intended uses for existing registered devices are now expressly catered for. Prior regulatory approval to conduct these trials and investigations is now required. The content of the application for regulatory approval and the process involved dovetail well with what is currently applicable to medicines. Compliance with good clinical practice guidelines is similarly of foremost concern. Carrying out an unauthorised clinical trial or investigation will be seen as an offence and carries a penalty of 10 years’ imprisonment.
“As with the regulatory regime for medicines, additional guidance has been provided regarding advertising, labelling and instructions for use which must accompany medical devices and IVDs. In so far as devices are intended to be marketed and sold directly to consumers, regard must also be had to the Consumer Protection Act 2008 and its regulations governing the labelling of products.
“Additional record-keeping is now mandatory for Class D (high risk) implantable medical devices. Manufacturers, wholesalers, distributors and health institution suppliers and professionals are required to keep permanent a record of details of each transaction involving the supply of Class D devices, with a statutorily prescribed document retention period ranging between 5 and fifty years.
“These are some of the salient features of the new regulations that are most likely to impact on industry stakeholders in the near future. A number of transitional arrangements have been incorporated to ensure that business and trading activities of manufacturers, distributors and wholesalers and other persons operating in this sphere continue for the time being and that these are to be considered legal. From time to time, the regulator may publish call-up notices in the Government Gazette, calling on stakeholders to apply for licences in terms of the new regime as well as registration of the stipulated categories and classes of devices. Until that occurs, manufacturers, distributors and wholesalers may continue to trade lawfully.
“Questions remain about the nature and precise role of the regulator. Despite many false starts, the groundwork has finally been laid for the conversion of the MCC and the establishment of a new regulator, to be known as the South African Health Products Regulatory Authority (SAHPRA), which will have broad powers and over-arching authority to monitor and enforce legislation applicable to all medicines, medical devices, cosmetics and foodstuffs in the country. For many stakeholders in the healthcare sector, this expression of regulatory certainty cannot come soon enough.”