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avatar for Andrea Keyter

Andrea Keyter

South African Health Products Regulatory Authority
Deputy Director, Medical Devices
Andrea is a pharmacist and has 10 years of experience within the field of regulatory affairs, quality assurance, quality risk management, pharmaceutical production, complementary medicines manufacture and risk-based inspection planning. In her current role, Andrea is responsible for the application of the medical device regulatory framework in South Africa and for the regulation of medical devices and in vitro diagnostics in South Africa. She is the Chair of the Pan African Harmonization Working Group, a body for regulators of medical devices in Africa that aim to improve access to medical devices and diagnostics in Africa though harmonized regulation whilst ensuring the safety, quality and performance of the devices.