Guidance on South African medical device and IVD regulation, including classification, registration, technical documentation, regulatory pathways and product compliance.
Published: 12 September 2023 Last updated: 30 September 2026 Medical devices and IVDs in South Africa are regulated through a combination of legislation, SAHPRA regulations, establishment licensing requirements, quality management obligations and product-specific controls. For manufacturers, importers, distributors and wholesalers,…
Regulatory reliance is becoming increasingly important for manufacturers seeking to place medical devices and in vitro diagnostic medical devices, or IVDs, on the South African market. On 25 February 2026, the South African Health Products Regulatory Authority, SAHPRA, published SAHPGL-MD-22,…
Medical device registration in South Africa is often misunderstood because the country’s regulatory framework combines establishment licensing, product listing, classification and a developing product-registration system. Manufacturers entering South Africa sometimes assume that every medical device must first receive an individual…
Medical device classification in South Africa is based on risk. Every medical device and in vitro diagnostic medical device, or IVD, must be assessed against the applicable South African classification rules to determine whether it falls into Class A, B,…
Software can be regulated as a medical device in South Africa. The Medicines and Related Substances Act expressly includes software within the definition of a medical device where the product is intended by its manufacturer for a medical purpose such…
A Global Medical Device Nomenclature, or GMDN, code provides a standardised way of identifying a generic type of medical device or in vitro diagnostic medical device, or IVD. For companies operating in South Africa, GMDN codes have a direct regulatory…