The State of Medical Device Regulation in South Africa
Medical devices play a critical role in healthcare, ranging from simple tools like thermometers to complex systems such as surgical robots. Despite their importance, the regulatory framework for these devices in South Africa has not always been comprehensive. Unlike with medicines, most diagnostic tests and medical devices are not subject to rigorous safety and efficacy assessments before being sold on the market. However, recent developments suggest that this is changing.
Understanding Medical Devices
A medical device is any instrument, apparatus, or machine intended for use in the diagnosis, prevention, monitoring, or treatment of a disease or other medical condition. This broad definition includes everything from bandages and blood pressure monitors to MRI machines and pacemakers. Some devices are used briefly and then discarded, while others are implanted in the body for long-term use.
While many medical devices are used in clinical settings, others are designed for home use, such as thermometers, condoms, and blood pressure monitoring devices. The World Health Organization estimates that there are over two million different types of medical devices globally, highlighting the vast diversity of products in this category.
Regulatory Oversight in South Africa
The South African Health Products Regulatory Authority (SAHPRA) is responsible for ensuring the safety and effectiveness of medical devices in the country. Although SAHPRA has the legal authority to regulate all medical devices, the process is still evolving. Prior to the 2015 Medicines and Related Substances Amendment Act, only certain types of medical devices—such as those emitting radiation—were regulated.
The 2015 amendments expanded SAHPRA’s mandate to cover all medical devices, marking a significant shift in regulatory oversight. One of the first steps taken by SAHPRA was introducing licensing requirements for medical device companies. Over 2,500 companies now hold active medical device establishment licenses, which specify the types of devices they can manufacture, import, or distribute.
Medical devices are classified into four risk categories, with higher-risk devices requiring more stringent regulation. Bandages, for example, are considered low risk, while heart valves are high risk. This risk-based approach helps SAHPRA align its regulations with international standards and focus on the most critical products.
Quality Management and Certification
In addition to licensing, SAHPRA has introduced requirements for medical device companies to obtain ISO 13485 certification. This international standard ensures that companies have robust quality management systems in place. Initially, SAHPRA did not require this certification due to limited local accreditation bodies. However, six local conformity assessment bodies are now accredited to provide ISO 13485 certification.
Companies renewing their five-year licenses must either provide proof of ISO 13485 certification or demonstrate that they are in the process of obtaining it. This step aims to ensure that medical devices meet global quality standards before reaching the market.
Challenges in Device Regulation
Despite these efforts, medical devices themselves remain largely unregulated in South Africa. This means that some devices may be marketed without independent verification of their safety or performance. SAHPRA acknowledges that registering the over 200,000 medical devices currently in use is a massive task.
To address this, SAHPRA is conducting a feasibility study to determine how to implement device registration effectively. The study will include 32 medical devices related to HIV and TB, including in vitro diagnostic tests, condoms, and X-ray devices. Half of the products will be locally manufactured, while the other half will be imported, allowing SAHPRA to test its approach for both locally and internationally assessed devices.
Emergency Authorizations During Public Health Crises
During the COVID-19 pandemic, SAHPRA introduced emergency authorisation listings for certain medical devices. In 2024, it also required approval for Mpox diagnostic tests. These measures allow the use of unregistered products under specific conditions, such as during public health emergencies.
Section 21 authorisation has been used to ensure that substandard products are not distributed, particularly during crises when rapid response is essential. SAHPRA continues to work with regional partners to ensure that diagnostic tests used across Africa are reliable and effective.
