Republic of South Africa
South Africa has around 60 million inhabitants and is the largest economy on the continent. South Africa is a multi-ethnic society encompassing a wide variety of cultures, languages and religions.
Its largest cities are Johannesburg, Cape Town, Durban and Pretoria (the capital). About 9% of GDP is spent on healthcare, whereby more than 80% of the population depends on the public healthcare system. The remaining 20% uses private healthcare. Roughly 80% of this group is part of a medical scheme, the remaining 20% pays for private care out-of-pocket or through in-hospital-only plans. The largest schemes are Discovery Health, the Government Employees Medical Scheme (GEMS) and Bonitas Medical Fund. Its high level of inequality is reflected in one of the highest Gini coefficients worldwide. As a result, the country faces significant disparities in healthcare access and quality.
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Public Healthcare
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The public healthcare system is funded mainly through taxes and provides free or low-cost services to all citizens, especially to those who cannot afford private healthcare. Its system is heavily underfunded and faces resource shortages, including medical staff, equipment, and drugs. South Africa faces a shortage of skilled healthcare workers, including doctors, nurses, and specialists, particularly in rural and underserved areas. Overcrowding in public hospitals and clinics is common, leading to long waiting times. The quality of care varies widely, with some facilities providing good services while others are poorly equipped.
Public healthcare is provided through a network of primary healthcare clinics, district hospitals, and regional or tertiary hospitals. The system is divided into nine provinces, each managing its own healthcare services with varying levels of success. The government has been working toward implementing National Health Insurance (NHI) to provide universal health coverage and pay for healthcare services for all South Africans. This system is intended to reduce the gap between public and private healthcare.
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Private Healthcare
Private healthcare in South Africa is of a higher standard, offering faster and more specialized services compared to the public sector. However, these services are expensive and are typically available to those with private medical insurance or those who can afford to pay out of pocket. South Africa has a strong medical insurance market. These schemes allow people to access private hospitals, specialists, and healthcare services, with varying degrees of coverage depending on the plan. The largest schemes are Discovery Health, the Government Employees Medical Scheme (GEMS) and Bonitas Medical Fund.
Major private hospital groups, such as Netcare, Mediclinic, and Life Healthcare, operate throughout the country. These hospitals offer high-quality healthcare but can be prohibitively expensive for those without insurance.​​
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​Key Health Issues
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HIV/AIDS: South Africa has one of the highest rates of HIV infection in the world, with millions of people living with the virus. The government has rolled out antiretroviral treatment (ART) programs to combat the epidemic, which has considerably increased life expectancy.
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Tuberculosis (TB): TB is another major health issue, often co-infected with HIV. The country faces difficulties in controlling multi-drug-resistant TB (MDR-TB).
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Non-Communicable Diseases (NCDs): Like many other countries, South Africa is seeing a rise in diseases like diabetes, hypertension, and cardiovascular diseases, largely due to lifestyle factors.
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Maternal and Child Health: Maternal and child mortality rates remain high compared to global averages, although there have been improvements in recent years with better healthcare interventions and services.
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​Medical device and IVD registration
The Medical Devices Unit of SAHPRA (https://www.sahpra.org.za/) is responsible for the licensing of medical devices as well as IVDs to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance.
Classification
Medical devices and IVDs in South Africa are classified based on the level of risk they present, where risk relates to the patient, user or to public health. The classes are:
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Class A (low risk)
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Class B (low-moderate risk)
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Class C (moderate-high risk)
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Class D (high risk)
The classification determines the requirements for the registration process. Class A devices have less stringent requirements, while Class D devices have the most extensive requirements.
Authorized representative
Hiring a Local Authorized Representative (LAR) is a must for any foreign manufacturer who doesn’t have an official existence in the country. The LAR must be a resident of South Africa, should be familiar with the regulatory business and regulatory process in South Africa . The LAR is the person responsible for communication with the local regulation authorities.
Registration process, approval and issuance of Registration Certificate
Once the LAR has been appointed, and the class of the medical device determined according to the local rules of Classification of Medical Devices and IVDs, the LAR collects the requested documents that compose the application dossier for registration of the medical device (or group/family, etc). The application dossier typically includes:
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The application form filled with the requested information;
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Device description: information on the device's intended use, operating principles, and specifications;
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Clinical evaluation report;
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Risk management file: a risk analysis and management plan, especially for higher-risk devices;
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Quality Management System (QMS) certificates: evidence that the manufacturer complies with quality standards such as ISO 13485 (and others when applicable);
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Instructions For Use (IFU) of the medical device or IV and /or User Manual (can be both);
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A proposed label for use on the medical device or IVD, if applicable;
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A certified copy of the conformity assessment certificate to a quality standard for the medical device or IVD to be registered that is issued by a conformity assessment body;
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The proof of payment of the applicable fee;
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Declaration Of Conformity (DOC);
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A certified copy (-ies) of the different certificates of registration issued abroad;
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Certificate of Free Sale (CFS).
Further documents may be required for high-risk medical devices.
​The application for registration must be submitted to the SAHPRA by the LAR either via their online portal or in paper form.
SAHPRA will review the submitted documentation. The review process may take several months, depending on the complexity of the device and its classification. For higher-risk devices, the committee of experts responsible for the evaluation of the medical device registration applications within SAHPRA may request additional data or clarification, including clinical trials data or a more in-depth assessment of the risk management system. SAHPRA may also require an onsite inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP).
A satisfactory evolution of the application together with the onsite inspections results should lead to issuing a Registration Certificate (RC). This certificate is required prior to importing the medical device or IVD into the country.
The registration Certificate is valid for a period of 5 years.
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Key Tips
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Ensure that your device complies with South African standards and regulations;
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Maintain an updated QMS and adhere to international standards such as ISO 13485 for medical devices;
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It’s recommended to work closely with a local authorized representative expert to make your registration experience an enjoyable one.
Post-Market Surveillance (PMS) and Compliance
As part of PMS responsibilities & requirements, the manufacturer and its local authorized representative must comply with ongoing regulatory requirements. These include and are not limited to post-market surveillance, reporting adverse events, and periodic renewal of the registration certificate.
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SAHPRA must be notified of any changes that may affect the medical device registration. Medical device registration must be renewed periodically. This involves submitting updated documents including any new information related to the device’s safety and efficacy. SAHPRA charges fees for the registration process, the inspections, the renewal etc.
Special Considerations for In Vitro Diagnostics (IVDs)
IVDs have their own specific registration rules when it comes to requirements, process and PMS and they are regulated separately under the IVD regulations.
It is recommended to work closely with a local expert to assure the registration is done in a correct and efficient way.
For further details, the official SAHPRA website provides the most accurate and updated guidance on the registration process, as well as the forms and procedures (https://www.sahpra.org.za/)
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