Ms Khanyisile Nkuku in her current role 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 has over 6 years experience within the medical device regulatory space .
She holds a Bachelor of Pharmacy honours degree from the University of Witwatersrand, M.Sc in pharmacy administration & policy regulations from University of Western Cape and is currently busy with Master of Business Administration in Healthcare Leadership at University of Witwatersrand.
She is an experienced pharmacist with successful background in medical device & IVD regulations , regulatory system strengthening , global harmonisation initiatives, medical device clinical trials regulation, law enforcement, post marketing surveillance, and good reliance plus regulatory practice. Having great strength in Health products policy advocacy, development, implementation and compliance.
She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF) working groups including African Union African medicines regulatory harmonisation continental Medical device assessments committee as an assessor and member , she is further a committee member for two South African Bureau of Standards Technical committees as well as HPSCA task team .