Medical Devices & Consumer Health Products 2021

Last Updated August 31, 2021

South Africa

Law and Practice

Authors



Fasken is an innovative and forward-thinking business and litigation law firm. The team of over 750 lawyers provides expertise in every sector, including complex and high-profile matters across more than 40 practices and industry specialties. In the life sciences area, the firm has expertise in the regulatory, marketing, intellectual property, competition, tax, litigation, and business law matters unique to this sector. It also has a strong history of providing multidisciplinary legal solutions that protect client interests as their products and devices move from conception and research to registration and clinical or consumer use. The Life Sciences industry group is an established group within the broader Fasken family of lawyers. The advantage of this relationship is that the Johannesburg office has access to expertise internationally with experience in matters which have recently been launched in South Africa. An example of this would be the developments relating to the registration of devices in South Africa which have already been registered in Canada for many years.

The product safety regulatory regime under South African law for medical devices, pharmaceuticals, blood products, personal protective equipment and medical instruments (collectively referred to as “health products”) is fairly robust.

Medical Devices and Instruments

Medical Devices, which in South African law includes medical instruments, are governed by the following pieces of legislation.

  • The Medicines and Related Substances Act (Act No 101 of 1965) (as amended by the Medicines and Related Substances Amendment Act 14 of 2015) (the Medicines Act) which, amongst other things, provides for the registration of medicines intended for human and animal use, for the registration of medical devices, for the establishment of the South African Health Products Regulatory Authority (SAHPRA) (formerly the Medicines Control Council), and for the control of medicines, scheduled substances and medical devices. 
  • The Regulations to the Medicines Act relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) (Medical Devices Regulations) stipulate licensing requirements for medical devices, which apply to South African-based companies that manufacture, import, export, distribute and sell wholesale medical devices in the country; they also outline the licence application processes for manufacturers, wholesalers or distributors of medical devices and IVDs, procedures for device registration, and requirements relating to advertising and labelling.
  • The Hazardous Substances Act (Act No 15 of 1973) (the Hazardous Substances Act) provides for the evaluation and registration of non-ionising radiation emitting devices and radioactive nuclides; it also prohibits and controls the importation, manufacture, sale, use, operation, application, modification, disposal or dumping of substances and (electronic) products that may cause injury or death due to their detrimental direct or indirect effects.

The classification of medical devices in South Africa is governed by the provisions and requirements of the Medicines Act, read together with the Medical Devices Regulations. There are four potential classes of medical devices, those being:

  • Class A – low risk;
  • Class B – low-moderate risk;
  • Class C – moderate-high risk; and
  • Class D – high risk.

The manufacturer or distributor of a device is responsible for determining the classification of a device in accordance with the guidelines supplied by SAHPRA, based on the following factors:

  • the manufacturer’s or distributor’s intended use of the device;
  • the level of risk to patients, users and other persons (that is, the probability of occurrence of harm and the severity of that potential harm);
  • the degree of invasiveness in the human body; and
  • the duration of use and exposure to the device.

It is important to note that different parts of a single medical device can be classified under different categories. In the event that this is the case, the higher classification will apply to the device as a whole. An applicant that intends to supply medical devices in South Africa should be cognisant of the fact that the classification of medical devices in South Africa may differ from other countries.

Pharmaceuticals and Blood Products

The term "pharmaceuticals" refers to medicines for human use and includes new medicines, generic products, biological medicines and complementary medicines. Blood products are grouped under biological medicines together with hormones, vaccines and similar substances.

Pharmaceuticals and blood products are regulated by the following legislation.

  • The Medicines Act.
  • The General Regulations to the Medicines Act (General Regulations), which regulate the supply and registration of medicines and make provision for, amongst other aspects:
    1. the classification of medicines;
    2. requirements in relation to labelling;
    3. permits, licencing and authorisation;
    4. various activities including manufacturing, importing, exporting, wholesale and distribution of medicines;
    5. the conduct of clinical trials; and
    6. the management of medicines, including market vigilance and advertising.
  • The National Health Act (No 61 of 2003) (the National Health Act), which establishes a framework for a structured uniform health system within South Africa; it provides for the establishment of a National Health Research Ethics Council, which is a statutory body empowered, amongst other aspects, to set norms and standards for conducting research on humans and animals and the conducting of clinical trials.

Medicines in South Africa are subject to a system of scheduling on the basis of the active pharmaceutical ingredients that they contain. The primary consideration in scheduling a substance is its safety profile, in relation to the therapeutic indications for its use.

Scheduling determines the extent to which a medicine can be accessed. For example (the list that follows is not exhaustive of the Medicines Act or the requirements set out in Section 22A):

  • Schedule 0 substances may be sold in an open shop;
  • Schedule 1 substances may not be sold by, inter alia, any person other than a pharmacist, a manufacturer of or wholesale dealer in pharmaceutical products;
  • Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substances shall not be sold by any person other than a pharmacist to a person with a script; and
  • Schedule 8 substances shall not be acquired by any person other than the Director-General for the purpose of providing same to a medical practitioner on prescribed conditions, for the treatment of a particular patient.

Personal Protective Equipment

Personal protective equipment (PPE) is governed by the Occupational Health and Safety Act, 1993 (Act No 85 of 1993) (the OHS Act), which sets out an employer’s obligations in relation to PPE. 

Of note to the current COVID-19 pandemic and the subsequent surge in the design and manufacture of PPE is that in certain cases, PPE may fall under the definition of a medical device depending on its formulation (for example, a face mask with a filter assembly) and would therefore require classification. In these instances, the Medicines Act and its corresponding Medical Devices Regulations would find application.

Certain types of PPE and protective medicines fall under differing regulatory regimes by virtue of their classification, with same being dependent largely on design and intended use. 

General versus surgical face masks

General face masks, such as those made of textile or fabric cloth, are not regarded as protective against respiratory viruses and manufacturers of same may not claim that such masks protect the user or the public from infectious agents. These accordingly do not fall under the regulatory control of the Medicines Act or the National Regulator for Compulsory Specifications Act, 2008 (Act No 5 of 2008) (the NRCS Act) and do not require classification and registration with SAHPRA or the National Regulator for Compulsory Specifications (NCRS).

In contrast, surgical masks and medical respiratory masks are designated as Class A or Class B medical devices and are subject to the control and scope of the Medicines Act. Compliance with the appropriate South African National Standards (SANS) recommendations is required when it comes to the packaging and labelling of these products.

Respiratory protection equipment

Respiratory protection equipment is also subject to various other legislative provisions, such as the OHS Act, depending on the intended function of the mask and the environment in which it is employed. This might include, for example, requirements for training and intended usage in the workplace (such as in a mining or heavy manufacturing context).

Sanitising products

Sanitising products may fall into various regulatory groups depending on:

  • the application surface (human skin or inanimate surface);
  • the environment the sanitiser is used in (place of use);
  • the intended use and function; and
  • the composition.

Hand sanitisers, disinfectants and germicides used on inanimate surfaces in low risk areas within the home, public venues (for example, schools and restaurants), health institutions, health professional consulting rooms and clinics are regulated under the Foodstuffs, Cosmetics and Disinfectants Act (Act No 54 of 1972) (the FCD Act). Hand sanitisers must comply with the national standard (SANS 490: 2013 - Disinfectant alcohol-based hand rub) in terms of packaging and labelling and any compulsory standards issued by the NRCS.

Gloves

Gloves are classified into various regulatory groups based on their intended use. Gloves are regulated as medical devices under the Medicines Act if they are intended to be used by healthcare practitioners to safeguard the patient during a medical examination or surgical procedure. The applicable SANS standards must also be followed while using general gloves to safeguard the wearer (for example, in laboratories or for general protective purposes).

General Legislation of Application

In South Africa, product safety in general is governed by the Consumer Protection Act (No 68 of 2008) (the CPA). The CPA provides for the promotion of a fair, accessible and sustainable marketplace for consumer products and services and for that purpose, establishes national norms and standards relating to consumer protection, provides for improved standards of consumer information, prohibits certain unfair marketing and business practices, promotes responsible consumer behaviour, and promotes a consistent legislative and enforcement framework relating to consumer transactions and agreements. This consequently creates an obligation on suppliers of products (from the beginning to the end of a supply chain) to provide healthcare products and medical devices free of defects.

The product safety regulatory regime for cosmetics, food and nutrition in South Africa is the FCD Act and its corresponding Regulations, which aim to control the sale, manufacture and importation of foodstuffs, cosmetics and disinfectants.

The Regulations set out general provisions in respect of the advertising of foodstuffs, the presentation of foodstuffs, the letter sizes, identification, country of origin, batch identification, date marking, prohibited statements, negative claims, mandatory warnings on certain foodstuffs, special provisions, nutritional information, and claims and exemptions.

Cosmetics are not classified or scheduled in the same manner as medical devices or medicines, but are defined as: “any article, preparation or substance intended to be rubbed, poured, sprinkled or sprayed on or otherwise applied to the human body, including the epidermis, hair, teeth, mucous membranes of the oral cavity, lips and external genital organs, for purposes of cleansing, perfuming, correcting body odours, conditioning, beautifying, protecting, promoting attractiveness or improving or altering the appearance, and includes any part or ingredient of any such article or substance.”

Biocides are regulated by the Hazardous Substances Act. In general, and as discussed in 1.1 Medical Devices, the CPA would also be applicable to the safety of these products.

The product safety regulatory regime for new products, technologies and digital health is made up of a complex web of legislation, Regulations and guidelines issued by regulatory bodies.

Medical Apps

Product safety for medical “apps” is regulated by the following pieces of legislation:

  • the Medicines Act;
  • the Health Professions Act 56 of 1974 (Health Professions Act);
  • the CPA;
  • the Electronic Communications and Transactions Act 25 of 2002 (ECTA);
  • the Protection of Personal Information Act 4 of 2013 (POPIA); and
  • the Promotion of Access to Information Act 2 of 2002 (PAIA).

These pieces of legislation regulate both the medical devices and services provided on the application, as well as the laws surrounding the application itself. The intended use of the app will determine whether or not it will be classified as a medical device. For example, if it is used for the diagnosis, monitoring, treatment or alleviation of an injury or disease, the app is a medical device and must therefore comply with the Medicines Act. Over and above this, POPIA and PAIA regulate the patient information and data collected and utilised by these applications.

Telemedicine Products

The product safety of telemedicine products is regulated by the Health Professions Act and the Health Practitioners Council of South Africa: General Ethical Guidelines for Good Practice in Telemedicine (Booklet 10, August 2014). These Guidelines deal with patient safety in a telemedicine context, and address amongst other aspects, the healthcare practitioner-patient relationship within telemedicine services, assumption of primary responsibility (the consulting practitioner remains responsible for treatment decisions, and the servicing practitioner must keep detailed records of this advice) as well as the aspect of patient's informed consent.

Wearables

Wearables are regulated by the Medicines Act, as well as POPIA and the Legal Metrology Act.

Where a wearable (such as a fitness tracker) is intended by its manufacturer to be used for a regulated medical purpose, or is used as an accessory to a medical device, it is considered a medical device, and all the prescribed requirements relating to medical devices in the Medicines Act would find application, including but not limited to risk under the CPA in respect of product warnings. Care should therefore be taken in expressing the extent to which a wearable is capable of dispensing medical advice or being utilised as a diagnostic tool.

CBD Products

Cannabidiol (CBD) products are regulated by the Medicines Act. CBD is classified as a Scheduled 4 substance, however, subsequent to an amendment to the Schedules of the Medicines Act in May 2020, the following preparations containing CBD were excluded from the Schedules and reclassified as Schedule 0 substances:

  • in complementary medicines containing no more than 600 mg CBD per sales pack, providing a maximum daily dose of 20 mg of CBD, and making a general health enhancement, health maintenance or relief of minor symptoms (low-risk) claim; or
  • in processed products made from cannabis raw plant material intended for ingestion, containing 0.0075% or less of CBD, where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product.

The effect of this reclassification is that these products can be marketed and sold on the open market.

Health products which cannot be classified as either a pharmaceutical, medical device, cosmetic, food supplement, or biocidal product because they are indistinguishable from one another are referred to as "borderline" products until SAHPRA determines their categorisation status and assigns them to a specific regulatory pathway.

SAHPRA issued a guideline in 2017 to provide applicants with recommendations regarding the registration of borderline and combination products. However, the guideline, which proposes the framework discussed below, has not yet been finalised.

Medicines and Medical Devices

In terms of the guideline, SAHPRA will appoint a committee of experts from the various disciplines to assess and assign borderline products and combination products to a primary regulatory pathway. To do so, the experts will evaluate evidence presented in support of safety, quality, and efficacy (for medicines) or safety, quality, and performance (for medical devices). This ensures that similarly assigned products will be regulated in the same way. The primary mode of action, which is the mode of action that provides the most important therapeutic response, determines the designation of the borderline product to either the medicines or medical devices department.

Cosmetics, Biocides and Medicines

In relation to the above, in order to determine the regulatory pathway for cosmetics, biocides and medicine – biocides and medicines must be distinguished from cosmetics.

The main criteria distinguishing them is the products’ composition and the representations made about the product. Ultimately though, its intended purpose will outweigh these factors. Regard must therefore always be had to the definitions of “cosmetics” in the FDC Act and “medicine” and “medical device” in the Medicines Act when considering which regulatory pathway the borderline products within these categories should follow.

The requirements for and compliance by manufacturing entities of medical devices and related healthcare products in South Africa is regulated by SAHPRA with referral to the relevant legislative frameworks already discussed in 1. Applicable Product Safety Regulatory Regimes.

Requirements for Manufacturing Sites

Medical devices

Manufacturers or distributors of medical devices are required in terms of the Medicines Act and the Medical Devices Regulations to have a medical device establishment licence.

An application for a licence must be submitted to SAHPRA, together with the following:

  • the particulars of the owner;
  • the particulars of the authorised representative;
  • certification to a Quality Management System (QMS) for medical devices;
  • a list of all medical devices that it manufactures, distributes, or wholesales; and
  • the application fee.

In order for a manufacturer or distributor to be considered for a medical establishment licence, the applicant must comply with Good Manufacturing Practices (GMP) and should have available an implemented QMS addressing all aspects of quality assurance, those including:

  • purchasing processes;
  • manufacturing processes;
  • final product handling and storage;
  • facility installation;
  • servicing and cleanliness;
  • documentation controls and records;
  • international regulatory controls;
  • internal and external audits;
  • training;
  • complaint handling;
  • emergency plans and recalls;
  • quality assurance;
  • management review;
  • distribution (transportation, delivery, temperature control); and
  • export documentation (proof of export).

A licence is valid for a period of five years from the date of issue, which may be renewed thereafter by application to SAHPRA. The licensee must also pay the annual fee for continued registration as determined by SAHPRA.

As from February 2017, SAHPRA had been issuing an acknowledgment letter in lieu of the medical device establishment licence whilst its licensing process was in development. As of 31 March 2020, however, the use of an acknowledgment letter will not be permitted.

It should be noted that a manufacturer, distributor, wholesaler of a non-sterile, non-measuring Class A medical device is exempt from obtaining a medical establishment licence.

Medicines

An applicant can apply to SAHPRA for a licence to manufacture, import or export registered medicines and scheduled substances in South Africa. The application must be submitted to the Chief Executive Officer of SAHPRA and must include documentary proof of the owner of the business, registration of a responsible pharmacist, qualifications of key personnel, the ability to comply with good manufacturing, wholesaling or distribution practices and information specifying the medicines to be imported or distributed.

In addition to the relevant SAHPRA licence, an applicant will need a site licence from the National Department of Health and a South African Pharmacy Council licence as a Manufacturing Pharmacy. The provisions in relation to the GMP, QMF and Site Master File for a medical device establishment licence also apply to the licence to manufacture medicinal products.

Requirements for Specifications/Design for Manufacture of Products

A manufacturer of a medical device is responsible, in respect of each medical device, for:

  • determining the classification, intended purpose, and appropriate Global Medical Device Nomenclature (GMDN) system code for the medical device (GMDN codes are used by regulatory bodies to consistently describe medical devices having similar features, characteristics and intended use and to assist in the ongoing monitoring of medical devices once they are available for supply);
  • selecting and applying appropriate conformity assessment procedures to demonstrate compliance with the Essential Principles of Safety and Performance as prescribed by SAHPRA; and
  • notifying SAHPRA of substantial changes to the design, production or intended performance of the device.

In terms of the general Essential Principles of Safety and Performance that apply to all medical devices, the manufacturer must show that:

  • the use of the medical devices will not compromise the health and safety of a patient or user;
  • the design and construction of medical devices conforms to safety principles;
  • the medical devices are suitable for their intended purpose;
  • long-term safety is assured;
  • medical devices will not to be adversely affected by transport or storage; and
  • the benefits of the medical devices outweigh any undesirable effects.

Furthermore, there are Essential Principles of Safety and Performance regarding design and construction that apply to devices on a case-by-case basis. For example, the applicable principles may vary where there are chemical, physical and biological properties to the device; depending on the information to be provided with a medical device; and depending on clinical evidence.

Location Requirements in Respect of the Entity Responsible for Compliance

The application for a medical establishment licence to SAHPRA must be accompanied by proof of the existence of a manufacturing site, which may include a Site Master File. A Site Master File is prepared by the manufacturer and contains particular and factual GMP information regarding the production or control of pharmaceutical manufacturing operations at a specific site, as well as any closely integrated processes at adjacent and surrounding buildings.

To demonstrate compliance with GMP, the application must include:

  • a copy of a local area plan of the location of the business premises indicating all adjacent properties and the nature of the business being carried on, on such properties;
  • a floor plan of the building in which the business premises are situated;
  • a plan of the actual layout of the business premises;
  • an inventory of equipment to be used in conducting the business; and
  • a manual of procedures and practices to be implemented to ensure the safety, efficacy and quality of medicines, or Scheduled substances to be manufactured or distributed and sold.

Medical device establishments that apply to SAHPRA for a licence must designate an Authorised Representative for each location where they do business. The representative is in charge of ensuring that the legislation, regulations, and guidelines are followed.

The product life cycle of medical devices, medicines, and other related healthcare products speaks to the manufacture and distribution of the product, post-market vigilance and the eventual disposal of the device or the medicine.

Corporate Social Responsibility

Companies involved in the above-mentioned processes have corporate social responsibilities (CSR) within the South African socio-economic landscape. While South African legislation does not place an obligation on companies to fulfil their CSR, the King II and King III reports on corporate governance explicitly address the need for corporations to adopt a “triple-bottom line” approach and accordingly, many companies involved in the product life cycle comply.

Furthermore, the Broad-Based Black Economic Empowerment Act (Act No 53 of 2003) (the B-BBEE Act), which companies are required to comply with, is a legislative tool that has been used by the South African government to address the economic needs of historically disadvantaged persons. The spirit and purpose of the B-BBEE Act and its Codes of Good Practice embody the principles of CSR, in that they speak to the redress of inequities and the upliftment of communities.

The B-BBEE Act requires companies to be assessed for compliance with BEE measures through use of a generic scorecard. The indicators used to measure compliance (which can be specifically related to CSR) include, amongst other factors, ownership, management control, employment equity, skills development, preferential procurement, enterprise development and socio-economic development initiatives.

Each of these indicators is afforded an individual weighting, which results in a particular BEE status and a subsequent BEE recognition level. This level determines a company’s dealings with the State and/or any other business. Accordingly, compliance incentives and measures exist for companies producing, manufacturing and distributing healthcare products in South Africa to practise CSR.

Environmental Protection: Product/Device Disposal

With regards to the disposal of medicines and medical devices, and the impact of same on the environment, Regulation 14 of the Medical Devices Regulations prescribes that a medical device or IVD may not be disposed of into a municipal sewerage system, and specific disposal requirements must be followed.

Regulation 14 of the General Regulations to the Medicines Act provide that a medicine or scheduled substance shall only be destroyed by a waste treatment facility authorised to destroy medicines or pharmaceutical waste in terms of the National Environmental Management: Waste Act, Act 59 of 2008 (the Waste Act).

General

Advertising in general in South Africa is regulated by numerous pieces of legislation, including:

  • the Trade Marks Act, Act 194 of 1993;
  • the Copyright Act, Act 98 of 1978;
  • the FCD Act; and
  • the CPA.

In addition, the Code of Advertising Practice published by the Advertising Standards Authority (ASA) plays a significant role in the regulation of advertising. The ASA is an independent body established and funded by the marketing communications industry, and operates as the primary regulator of advertising in South Africa. The Code of Advertising Practice seeks to prevent the unfair manipulation of public opinion and choice and ensures that all advertising is truthful, honest and correct in all respects.

Medicines

The advertising of medicines is regulated under South African law with reference to their scheduling as follows:

  • Schedule 0 to 1 substances (over the counter (OTC) medicines) may be advertised to the general public;
  • Schedule 2 to 6 medicines (which require a prescription from a healthcare provider) may only be advertised to healthcare practitioners and may not be advertised to the general public; and
  • Schedule 7 to 8 medicines are prohibited from being advertised.

Medical Devices

Similarly, the advertising requirements for medical devices depend on the classification of the device (from Class A to D). Only Class A and Class B medical devices may be advertised to the public or a layperson. Class C and Class D medical devices may be advertised the same as Class A and B devices. However, when they are advertised to a prospective user for the first time, information specifying how to use the medical device must be included.

Marketing and advertising practices in relation to healthcare products are further guided by the following codes issued by the following self-regulating bodies.

  • The South African Code of Marketing Practice for Health Products (Marketing Code) published by the Marketing Code Authority (MCA); the MCA is a non-profit self-regulatory body, made up of manufacturers of medicines, medical devices and in-vitro diagnostics in South Africa.
  • The Medical Device Code of Ethical Marketing and Business Practice published by the South African Medical Technology Industry Association (“SAMED”); SAMED’s members include medical device, medical equipment and in-vitro diagnostic (IVD) companies in South Africa.

The CPA predominantly sets out the requirements for advertising and marketing of products and services (general, medical or otherwise). The CPA requires that the advertising and marketing of goods is to be done in a manner that is not reasonably likely to imply a false or misleading representation concerning those goods and is not misleading, fraudulent or deceptive in any way.

With respect to claims, suppliers are warned in the CPA that strict liability will be imputed onto producers, importers, distributors or retailers of any goods on which inadequate instructions or warnings are provided to the consumer relating to any hazard arising from or associated with the use of the goods.

No person may “go to market” (that is, sell, import, supply or export) a medicine, medical device, or IVD unless it complies with the requirements contained in the Medicines Act. This includes that the medicine, medical device, or IVD must be registered with SAHPRA.

Medicines

Any person (natural or legal) residing in South Africa may make an application to SAHPRA for the registration of a medicine. The application must be accompanied by:

  • a screening form completed by the applicant, which must contain particulars of the applicant, the prospective holder of certificate of registration and particulars of the medicine;
  • a proposed label for use on the medicine;
  • where applicable, a copy of the manufacturing licence together with the current GMP certificate from the regulatory authority of the country where the medicine is manufactured;
  • in the case of specified Schedule 5, 6, 7 and 8 substances, a certified copy of a permit to manufacture such substances;
  • all available data on the safety, efficacy and quality of the medicine;
  • proof of the existence of a manufacturing site;
  • the applicable application fee; and
  • the particulars of the person with appropriate knowledge of all aspects of the medicine who shall be responsible for communication with SAHPRA.

A medicine, in respect of which an application for registration is made, must comply with SAHPRA’s technical requirements and an application in respect of each individual dosage form and strength of a medicine must be made. If an application for registration is made for medicines that are or were registered with any regulatory body outside South Africa, a copy of the certificate of registration, professional information relating to the medicine, and conditions of such registration must accompany the application. The application must also be accompanied by one sample of such medicine.

Medical Devices

Medical devices cannot generally go to market in South Africa unless they are included in the South African Medical Device Register. In accordance with the Medicines Act and General Regulations for Medical Devices, an application for registration submitted to SAHPRA for review and approval must be accompanied by:

  • the completed appropriate application form;
  • the application fee;
  • the proposed label;
  • instructions for use;
  • a copy of the medical establishment licence; and
  • where conformity assessment evidence is required for the device, proof that the appropriate evidence has been obtained and is available.

Although, the Medicines Act and General Regulations provides for the above, SAHPRA’s registration process is currently in development. To ensure its mandate that medical devices are safe, effective and of good quality, when SAHPRA registers medical devices, it must "call-up" specific products or product classes for registration by publishing a call-up notice in the Government Gazette.

A draft call-up plan outlines the steps involved in this process. It explains that SAHPRA will use a risk-based approach in calling up medical devices for registration, prioritising the registration of more risky products and products of public health importance. Product call-ups will cover medical devices that are already on the market in South Africa as well as new medical devices that are being introduced. In the absence of medical device registration, SAHPRA has established several "quasi-registration" requirements as part of its medical device establishment licensing processes to enable oversight and control of medical devices used in South Africa.

New Product Technologies and Digital Healthcare

Manufacturers of new products technologies and digital healthcare products (including applications and wearables) that include a measuring instrument are required to be registered with the National Regulator for Compulsory Specifications in South Africa before proceeding to market.

The Legal Metrology Act defines a measuring instrument as: “…any appliance, equipment, instrument, software or apparatus or any combination thereof by means of which a measurement of physical quantity, expressed in any measurement unit or a mathematical function of measurement unit, may be made; and... includes any appliance, equipment, instrument, software or apparatus or any combination thereof by means of which a grading or counting in connection with the measurement of any physical quantity or a counting by means of gravitation may be effected.”

A physical quantity extends to any concept capable of being measured and of which the magnitude can be expressed in terms of a measurement unit (and accordingly, is not limited to physical measurements in the literal sense).

Sales and Pricing

The Medicines Act provides for a transparent pricing system which incorporates a single exit price (SEP) for medicines and scheduled substances. The SEP is the price at which manufacturers (including importers) are required to sell medicines and scheduled substances to anyone other than the government. A pharmacy, wholesaler, distributor, or any person licensed under the Medicines Act is prohibited from selling a drug for more than the prescribed SEP. However, pharmacists may charge an appropriate dispensing fee based on the recommendations of the Pricing Committee. This is, however, regulated by Section 22C of the Medicines Act.

As indicated by the legislation discussed throughout this chapter, South Africa has a robust legislative framework and an operational regulatory body. An ancillary, but relevant piece of legislation which would affect internationalisation plans for manufacturers in the country is the B-BBEE Act requirements (as discussed in 2.2 Corporate Social Responsibility, the Environment and Sustainability) which intends to advance historically disadvantaged persons, but creates further requirements for company compliance.

As is the case in all countries worldwide, there is always the risk of substandard and falsified health products (including medicines) coming onto the market which have the ability to negatively affect consumers. Although regulatory authorities and law enforcement bodies have different mandates, co-operation and the sharing of information is encouraged as their work relating to substandard or falsified health products may overlap.

This includes harmonisation initiatives through the African Medicines Regulatory Harmonization initiative (which focuses on harmonising the regulation of medical products in Africa) and the evolving African Medicines Agency (established by treaty through the African Union); rigorous prosecution of falsified health products; greater co-ordination between international and United Nations agencies; and enhanced information-sharing (eg, concerning medical alerts or evidence-based research for policy-making purposes).

SAHPRA provides guidance on the post-marketing surveillance (vigilance) obligations in respect of medicines and medical devices.

Medical Devices

The reporting requirements place a responsibility on the authorised representative, holder of the certificate of registration or manufacturers to inform SAHPRA of a suspected “adverse event” which was reported to them and which occurred as a result of usage of the medical device. The authorised representative, holder of the certificate of registration or manufacturers would be expected to report the event within a specific timeframe determined by the severity of the event.

An adverse event is defined by SAHPRA as: “an unintended and sometimes harmful occurrence associated with the use of a medicine, vaccine or medical device (collectively known as health products). Adverse events include side effects to medicines and vaccines, and problems or incidents involving medical devices. Examples of adverse events are any unfavourable and unintended sign, symptom or disease associated with the use of a health product. An abnormal laboratory finding could be one example of an unfavourable and intended sign.”

Where SAHPRA has identified a safety concern with a healthcare product it can take regulatory action to ensure that the products continue to have acceptable safety, efficacy/performance and quality for their intended use.

These regulatory actions include:

  • product labelling changes which can be the addition of warnings, precautions or adverse effects in the professional information and patient information leaflet;
  • distributing “Dear Healthcare Professional” letters or publishing medicine safety alerts in medical journals to inform healthcare professionals;
  • issuing of press releases to informing consumers;
  • limiting access to the health product by up-scheduling, limiting prescribers and population, etc;
  • suspending or cancelling the registration of the product; and
  • undertaking post-marketing studies by the holder of certificate of registration to investigate the safety concern if more information is needed.

Medicines

In addition to the general regulatory actions identified by SAHPRA in the event of a report of an adverse event, the holder of the certificate of registration or applicant should ensure that it has in place an appropriate system for pharmacovigilance that will provide for the proper management of safety data for its medicines and to ensure that appropriate action can be taken when necessary. It is a requirement that the applicant has available, in South Africa, a full-time qualified person responsible for pharmacovigilance and post-marketing surveillance.

Recall

The recall of medicines or medical devices can be initiated as a result of reports referred to the holder of the certificate of registration or other parallel parties. A recall can be premised on, among other things, the reaction to a particular batch (or batches), product quality deficiency, technical complaints experienced with regard to the printed packaging material, contamination, mislabelling and counterfeit products.

Should there be a need to conduct a recall of medicines or medical devices, the holder of the certificate of registration would be responsible for the recovery of the devices. Recalls are classified according to the level of risk of the hazard and the extent to which the product should be recalled from distribution. There are three types of classes:

  • Class I – defective/dangerous/potentially life-threatening;
  • Class II – temporary or medically reversible adverse health problems or mistreatment; and
  • Class III – defective but unlikely to cause any adverse health reaction.

In addition to SAHPRA’s requirements, Section 60 of the CPA provides for safety monitoring and recall of products in order to address product failures, defects, or hazards.

Upon recall, procedures for corrective action must be implemented, and the effectiveness of the results must be verified. It must be established whether the nonconformity is an isolated or recurring issue, and if necessary, whether any steps should be taken in this regard. Whereas corrective action is taken after non-conformity to prevent recurrence, preventative action should be taken when a potential non-conformity is identified to prevent occurrence.

Record-Keeping

The required standard operating procedures, legal records, documentation system, and electronic records should all be included in a documentation system maintained by the manufacturer as part of quality assurance. Any computerised document or format must adhere to current statutory requirements and/or international standards for electronic documentation and computer systems. Records should be made available for inspection by SAHPRA.

Written instructions and records, including all applicable receipts and invoices, should be accessible to document all operations connected to the distribution of pharmaceutical products. For each delivery, invoices or slips should be issued and delivered with the items. Records of the receipt and disposal of all products acquired and sold should be kept in a clear and accessible manner. Unless otherwise stipulated in national or regional laws, such records should be retained in an accessible form and manner for at least five years.

The responsible pharmacist of a wholesaler is responsible for maintaining and updating the Site Master File. The updated Site Master File should be submitted to SAHPRA at least every three years, or if any changes occur.

In so far as data arising from clinical studies is concerned, it is the responsibility of the principal investigator to collect, record, maintain and retrieve adequate and accurate source data. SAHPRA has provided a list of essential documents which should be maintained by the principal investigator during the course of a clinical trial and these essential documents must be retained for at least ten years after termination of the research project.

The key regulatory authorities for the medical devices and healthcare products sector in South Africa are:

  • the South African Health Products Regulatory Authority (SAHPRA);
  • the Health Professions Council of South Africa (HPCSA); and
  • the National Regulator for Compulsory Specifications (NRCS).

The regulators identified in 3.1 Regulatory Authorities perform the following functions and exercise the following powers.

The South African Health Products Regulatory Authority (SAHPRA)

SAHPRA regulates health products intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nuclides; and the conduct of clinical trials. SAHPRA has the power to grant/renew or revoke licences for the manufacturing and distributing of medicines and medical devices. SAHPRA is responsible for ensuring that medicines, medical devices and IVDs comply with the essential standards of safety, efficacy and quality to protect the health and well-being of South Africans.

The Health Professions Council of South Africa (HPCSA)

The HPCSA registers medical practitioners and specialists and has the power to set and maintain standards of ethical and professional practice including the provision of telemedicine by healthcare practitioners.

The National Regulator for Compulsory Specifications (NRCS)

The NRCS administers technical regulations and compulsory specifications on behalf of the National Department of Trade, Industry and Competition and is responsible for promoting public health and safety, environmental protection and ensuring fair trade.

Various different product safety offences and corresponding penalties exist with respect to differing medical devices and health products.

Medicines, Medical Devices and IVDs

In terms of Section 29 of the Medicines Act, product safety offences in respect of medicines, medical devices or IVDs include the contravention of, or failure to comply with, provisions of the Medicines Act dealing with the following:

  • prohibition on the sale of medicines and medical devices which are subject to registration and are not registered;
  • prohibition on the sale of medicines and medical devices which fail to comply with labelling and advertisement requirements;
  • prohibition on the sampling of medicines;
  • prohibition on the sale of medicines which do not comply with prescribed requirements;
  • publication or distribution of false advertisements concerning medicines; and
  • the disposal of undesirable medicines.

Any person who is convicted of an offence referred to in Section 29 shall be liable to a fine, or to imprisonment for a period not exceeding ten years. The court convicting any person of an offence under this Act may, upon the application of the prosecutor, declare any medicine, Scheduled substance, medical device or IVD in respect of which the offence has been committed to be forfeited to the State.

Cosmetics

The FCD Act recognises the following acts as offences in respect of cosmetics:

  • the manufacturing or importation of cosmetics that contain prohibited substances;
  • the manufacturing or importation of cosmetics which are contaminated, impure or decayed, or are in terms of any regulation deemed to be harmful or injurious to human health; and
  • false descriptions of cosmetics.

Persons convicted of the above offences will be liable to a fine and/or imprisonment. The duration of imprisonment is dependent on the number of convictions. 

Under South African common law, “claims” are restricted to financial claims that are brought to compensate a plaintiff for losses which occurred as a result of a defendant’s (normally a manufacturer’s) conduct and include claims for actual expenses incurred or to be incurred, general damages and where applicable, past and/or future loss of earnings.

A claim for general damages (arising from pain, suffering, loss of amenities of life and disability) may be available to a plaintiff who satisfies the requirements for a delict (tort) and is able to adequately quantify and prove their damages.

These claims are subject to the Prescription Act (Act 68 of 1969), in terms of which, a claimant must bring their claim within a three-year period, failing which, it will prescribe.

The CPA imposes strict liability on producers or importers, distributors or retailers for any harm caused by a product (which would include medical devices) caused wholly or partly as a consequence of:

  • supplying unsafe goods;
  • a product failure, defect or hazard in any goods; or
  • inadequate instructions or warnings provided to the consumer pertaining to any hazard arising from or associated with the use of any goods, irrespective of whether the harm resulted from any negligence on the part of the producer, importer, distributor or retailer, as the case may be.

Defences and Exemptions

Under the CPA, liability does not arise in the following instances.

  • Where a claim is brought more than three years after the:
    1. death or injury of a person;
    2. the earliest time at which a person has knowledge of the material facts about an illness; or
    3. the latest date on which a person suffered any economic loss arising from the death, illness or injury to any natural person.
  • When the product's unsafe characteristic, failure, defect or hazard resulting in harm is wholly attributable to compliance with any public regulation.
  • When the product's alleged unsafe characteristic, failure, defect or hazard:
    1. did not exist in the goods at the time it was supplied by that person to another person alleged to be liable; or
    2. was wholly attributable to compliance by that person with instructions, which were provided by the person who supplied the goods.
  • Where it is unreasonable to expect the distributor or retailer to have discovered the product's unsafe characteristic, failure, defect or hazard, having regard to that person's role in marketing the goods to consumers.

The primary grounds upon which a particular court in the country will be seized with jurisdiction over claims arising are:

  • residence of the defendant;
  • the place where the cause of action arose;
  • the place where the dispute arose;
  • the quantum and nature of the claim (which determine whether the High Court or the Magistrate’s Court (which has monetary jurisdiction of up to ZAR400,000) will have primary jurisdiction);
  • consent to jurisdiction (for the purposes of confirming but not founding jurisdiction in so far as persons/entities not resident in the country are concerned; and
  • property (immovable as well as movable – including corporeal and incorporeal) that can be attached to found jurisdiction by persons/entities not resident in the country.

As set out in Khumalo v Twin City Developers (328/2017) [2017] ZASCA 143 (2 October 2017): “it is a trite principle of South African law that a court considering an order of costs exercises an unfettered discretion. Equally trite is the principle that where the costs order sought includes the costs for the employment of two counsel, here too, the court exercises a discretion. The court’s discretion must be exercised judicially. It is well-established that in the ordinary courts, the general rule is that ‘costs follow the result’... ”

The result of the general rule that costs follow the result is that a successful litigant is generally awarded costs. However, a court is at all times at liberty to utilise discretion when making a costs award. There are however measures which can be utilised to protect against adverse costs orders.

Rule 34 of the Uniform Rules of Court

This rule provides that in any action brought in the High Court in which a sum of money is claimed, either alone or with any other relief, the defendant may at any time unconditionally or without prejudice make a written offer to settle the plaintiff’s claim. The same offer can be tendered by the defendant to make performance of any act sought by the plaintiff. No offer or tender in terms of the rule made without prejudice can be disclosed to the court at any time before judgment has been given. The fact that an offer or tender referred to in the rule has been made may only be brought to the notice of the court after judgment has been given, said disclosure being relevant to the question of costs.

Calderbank Offers

Similarly, Calderbank offers have been incorporated into South African law in the matter of D and Another v MEC for Health and Social Development, Western Cape Provincial Government 2017 (5) SA 134 (WCC) and are used predominantly in arbitration proceedings where the Rules of Court may not be the agreed choice of rules for the conduct of the proceedings. Should a Calderbank offer which complies with the requirements for an offer of this nature be tendered by the defendant, and the plaintiff be awarded less than the amount tendered, the Calderbank offer can be brought to the attention of the judge or arbitrator during the determination of costs. The plaintiff is then at risk of having to pay costs from the date on which the Calderbank offer was rejected, or alternatively, the date on which the offer expired.

Judicial Review of Decisions

The decisions of a public, regulatory body which involve the exercise of a discretion, are subject to judicial review both under the common law of rationality and the Promotion of Administrative Justice Act, Act 3 of 2000 (PAJA). PAJA lists specific grounds upon which a decision by an administrator can be reviewed, and prescribes that any review launched in terms of the Act must be undertaken within 180 days of the decision.

Inquests into Deaths Arising from Unnatural Causes

To the extent that it is believed or alleged that a person has died as a result of an allegedly defective product (that is, due to a cause other than a natural one), the Inquests Act, Act 58 of 1959 requires that the death be reported to the police. Once reported, the police must investigate or cause to be investigated the circumstances of the death or alleged death, which includes an examination by the District Surgeon or a medical practitioner of the body, and a subsequent report to the public prosecutor.

The Constitution of South Africa, 1996 provides a mechanism for class actions concerning an infringement of a right in the Bill of Rights. In this instance, this right may, for example, be the infringement of a right to bodily integrity. Despite the above seemingly placing a limitation that a class action can only be brought where a constitutional right has been infringed, there is no statutory definition that defines the requirements of a class action. The CPA for example establishes standing for “a person acting as a member of, or in the interest of, a group or class of affected persons”.

In order to bring a class action, the class must first be certified as such by a court. This certification process ensures that a class action would be appropriate for the matter at hand. It is important that the applicant proves that all individuals part of the class action have legal standing in the matter and that they have been given sufficient notice and will be bound by the judgment. Similarly, where a class action has been brought in delict, every claimant must be able to prove the elements of the delict. 

An example of a prominent class action brought in South Africa is that of the silicosis/tuberculosis case. In December 2012, several former gold miners suffering from silicosis and/or tuberculosis filed a class action against 30 gold mining companies, on the basis of the allegation that the companies failed to take adequate safety measures (as required by the Mine, Health and Safety Act, Act 29 of 1996) to protect miners from exposure to silica dust. The matter was however, settled and an application was brought by the applicants to approve the settlement agreement between the parties.

See 4.6 Mass Tort Litigation.

Mediation

Parties have the option of referring a dispute between them to mediation under the Arbitration Foundation of Southern Africa (AFSA) Mediation Rules. In terms of the Rules, the mediator will conduct the process with fairness to all parties and will take particular care to ensure that all parties have adequate opportunities to be heard, to be involved in the process and to have the opportunity to seek legal or other advice before finalising any resolution.

Agreement to Private Arbitration

Another mechanism which is available to parties in respect of product-related contentious matters is agreement to private arbitration. Where parties elect to proceed with this route, an arbitration agreement is typically drawn up which sets out the terms of the arbitration. These terms will set out the manner in which the arbitration will be conducted and select a set of rules to govern the arbitration, for example, the Uniform Rules of Court, or AFSA Rules.

It is commonplace for civil litigants to threaten:

  • the laying of criminal charges (in which event the burden of proof is the more stringent one of "beyond reasonable doubt" as opposed to the civil burden of proof which is "on a balance of probabilities"); and
  • adverse publicity in the media.

There is no doubt a link between product safety compliance and product liability claims – the former being used as evidence to support the latter.

The proposed National Vigilance Policy for Health Technologies, published for comment in May 2020, aims to establish an improved vigilance system in South Africa to ensure the early diagnosis of health technology-related adverse reactions, interactions, and other medicine-related difficulties, as well as the detection of previously unknown adverse reactions.

The system further intends to guarantee that changes in the risk and/or benefit balance of health goods are communicated to stakeholders in order to promote patient safety, including the rational and safe use of medicines, medical devices and other health products.

The draft amendments to the Regulations relating to medical devices, 2021 (GN - 435/GG - 44593) aim to streamline the regulation of the supply, registration, licensing, management and investigation of medical devices as well as offences and penalties. Once these amendments are passed, the Medical Devices Regulations will be repealed. Interested parties have until 25 August 2021 to submit any comments, in writing, on the proposed regulations to the Director-General of Health.

Brexit has had no direct or indirect effect on the regulatory regimes in relation to medical devices and related healthcare products in South Africa.

Due to the global impact of COVID-19, SAHPRA is prioritising all COVID-19-related health product applications and has adopted a priority review approach to applications for the registration of a vaccine in order to expedite access to the South African public, without compromising the standards of quality, safety and efficacy.

In an effort to enable and support the country’s response in fighting the COVID-19 pandemic, SAHPRA has also approved and granted a number of Section 21 applications. Section 21 of the Medicines Act makes provision for the authorisation of the sale of unregistered medicines or medical devices for certain purposes. A number of vaccines have been approved under Section 21 and manufacturers have been permitted to sell rapidly developed non-invasive and invasive ventilators, which have not been registered, in accordance with Section 21.

Special attention is also being given to tracking adverse reactions to the COVID-19 vaccines. Although it is commonly known that all vaccines have side effects, moderate to severe side effects are required to be thoroughly investigated. 

SAHPRA has requested that pharmaceutical and medical device manufacturers and suppliers, for both public and private sectors, notify it of any anticipated disruptions in supply; shortages of products; and any planned withdrawals of products from the market. This information must be reported as soon as it comes to the attention of manufacturers or suppliers.

Fasken

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Johannesburg
South Africa

+27 011 586 6000

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tsiciliano@fasken.com www.fasken.com/en
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Law and Practice

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Fasken is an innovative and forward-thinking business and litigation law firm. The team of over 750 lawyers provides expertise in every sector, including complex and high-profile matters across more than 40 practices and industry specialties. In the life sciences area, the firm has expertise in the regulatory, marketing, intellectual property, competition, tax, litigation, and business law matters unique to this sector. It also has a strong history of providing multidisciplinary legal solutions that protect client interests as their products and devices move from conception and research to registration and clinical or consumer use. The Life Sciences industry group is an established group within the broader Fasken family of lawyers. The advantage of this relationship is that the Johannesburg office has access to expertise internationally with experience in matters which have recently been launched in South Africa. An example of this would be the developments relating to the registration of devices in South Africa which have already been registered in Canada for many years.

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