Ms Khanyisile Nkuku In her current role she contributes her expertise in the assessment and registration of medical devices & IVD’s in South Africa in an effort to promote medical device & IVD access on a global scale, with a particular focus on African countries.

She holds a Bachelor of Pharmacy honours degree from the University of Witwatersrand, Master’s in Pharmacy administration & Policy Regulations from University of Western Cape and is currently busy with Masters in Business Administration in Healthcare Leadership at University of Witwatersrand.

She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening. Having great strength in policy advocacy, policy development, policy implementation and compliance. She has experience and knowledge in medical device & IVD registration, clinical trials regulation, law enforcement, post marketing surveillance, and good reliance plus regulatory practice.

She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF) working groups. She is further a committee member for two SABS Technical committees as well as HPSCA task team .