Medical Device Regulation Guidance

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.

A guide to applying for a Medical Device Establishment Licence
January 2024
This guidance document is aimed at supporting medtech suppliers with applying for a Medical Device Establishment License with the South African Health Products Regulatory Authority (SAHPRA)

South African medtech regulations – overview presentation
12 May 2021
This overview presentation of the medical technology regulations in South African was presented at a SAMED Regulatory Forum.

Quick tips for medical devices – presentation
12 May 2021
This presentation on quick tips and key regulatory/principal considerations for medical devices was presented at a SAMED Regulatory Forum.

Quick tips for medical technology manufacturers – presentation
12 May 2021
This presentation providing quick tips for manufacturers on the regulations in South African was presented at a SAMED Regulatory Forum.

Quick tips for in-vitro diagnostics – presentation
12 May 2021
The South African Laboratory and Diagnostics Association presented quick tips for IVD regulations in South Africa at a SAMED Regulatory Forum.