Medtech Regulations Library

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 South African Health Products Regulatory Authority (SAHPRA)

SAMED Position Paper & Principles of SA Medical Device Regulation

SAMED Submissions on South African Medical Device Regulation

SAMED Submissions on Private nursing practitioner licencing regulations

Medical Device and IVDs Regulations: guidance documents

African Medical Device & IVD Regulatory Resources

Post-market surveillance, vigilance and recall resources

18 A & 18 B Exemption Notice for Medical Devices and IVDs

ISO 13485 Communications and Resources

Global Medical Technology Alliance

International Medical Device Regulators Forum

Global Harmonization Working Party