South Africa SAHPRA Regulatory Requirements for Medical Devices and IVDs

Navigating South Africa’s Medical Device Regulatory Changes

South Africa’s healthcare system is in flux as the government works to implement a universal healthcare model. Until then, the industry is split between public and private systems that rely on imported medical devices. To navigate the complexity of the market, foreign manufacturers benefit from knowledgeable in-country distributors, importers, and representatives. The regulatory scheme for medical devices and IVD is also moving toward a more structured approach. Manufacturers need an establishment license to sell devices in South Africa and may also need to register devices once the new framework is in place.

Regulatory authority

Medical devices sold in South Africa are regulated by the South African Health Products Regulatory Authority (SAHPRA), a division of the National Department of Health. Device manufacturers must obtain an establishment license before selling products to South Africa. SAHPRA enforces establishment licensing and post-market requirements according to the Medicines and Related Substances Act, 1965 (Act 101 of 1965).

Device classification

Medical devices are classified into four tiers of increasing risk: Class A, B, C, and D. Classification is determined by a rule-based system that includes 16 rules in the Guideline for Classification of Medical Devices and IVDs. IVDs are also classified into Class A, B, C, and D, though the guideline includes a separate set of rules specific to IVDs. The license application also requires the device’s Global Medical Device Nomenclature (GMDN) code.

Registration process

Foreign and domestic manufacturers must apply for a manufacturer establishment license from SAHPRA. Application requirements include the completed license application, proof of payment of licensing fees, the Authorized Representative’s CV, Certificate of Free Sale (CFS), and (specifically for manufacturers) the quality manual. Class C and D devices must also provide proof of market authorization in an approved reference market, including Australia, Brazil, Canada, Japan, European Union, or United States. For high-risk IVDs, World Health Organization (WHO) certification and full technical documentation may be accepted in lieu of reference country approval. SAHPRA will conduct a completeness review followed by a regulatory review of your documentation and request more information as needed. A manufacturer license is issued on approval. Processes and procedures for individual device registration are pending.

Quality management system (QMS) requirements

Beginning June 1, 2025, new QMS requirements take effect. Manufacturers/distributors applying for a new or renewal Medical Device Establishment License must submit a valid ISO 13485:2016 certificate from a SAHPRA-recognized CAB.

• From now until April 1, 2025, a certificate is not mandatory, but alignment with the standard is expected.
• By April 1, 2028, SAHPRA will have verified certificates for all existing license holders.

In-country representation

Manufacturers located outside South Africa must retain an in-country representative based in South Africa called an Authorized Representative (AR). Your AR is your liaison to SAHPRA and other regulatory authorities. They are also responsible for ensuring your company’s compliance with local laws and guidelines.

SAHPRA Medical Device Registration Support in South Africa

Considering SAHPRA registration for your medical device or IVD? Our team of experts can help you strategize and coordinate market entry in South Africa. Contact us to learn more about SAHPRA medical device registration.