The South African Health Products Regulatory Authority

Disclaimer: The South African Medical Technology Industry Association (SAMED) provides this content as a complimentary service. The content is not a substitute for appropriate legal advice and is not binding on SAMED. SAMED, its board members, committees, employees and members, will not be responsible for any inaccuracies or omissions, or, liable for any damages or loss of whatsoever nature suffered by any person as a result of relying on or using the content provided.

The medical device unit of the South African Health Products Regulatory Authority (SAHPRA)  regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance. SAHPRA issues regular communications, guidelines, position papers and other medtech resources on their website.

Looking for a contact at the South African Health Products Regulatory Authority (SAHPRA)? SAHPRA has a list of key personnel to contact for finance, medical devices unit (including applications), regulatory compliance, radiation control and more.

SAHPRA issues regular Medical Devices and In-Vitro Diagnostics (IVD) communication to Industry.

Need to apply for a Medical Devices Establishment Licence? SAHPRA has application forms for and Medical Device and In-Vitro Diagnostics (IVD) manufacturers, wholesales and distributors.

To aid Medical Devices and In-vitro Diagnostics in navigating the regulatory requirements, the South African Health Products Regulatory Authority has a number of guidelines available to establishments.