Medtech Regulations Library

Technology and medical professional

Medical Device Regulation Guidance

Guidance documents created to navigate the South African medical device regulations.

African Medical Technology Regulations

Guidance documents to assist in navigating medical technology regulations in Africa.

Post-market surveillance, vigilance and recall

Guidance documents to assist in navigating medical technology vigilance and recall.

SAMED Medical Device Regulation submissions

On behalf of members, SAMED submitted commentary on the medical device regulations for consideration by the Regulator