Mr. David Aden Mwakyoma

Position: Medical Devices Officer, Tanzania Medicines and Medical Devices Authority (TMDA)
Categories: MedDevreg Speakers 25

Mr. David Aden Mwakyoma is a Medical Devices Officer at the Tanzania Medicines and Medical Devices Authority (TMDA), with a professional background in pharmacy and biomedical engineering. With over eight years of regulatory experience, he specialises in the assessment of technical information for medical devices and in vitro diagnostics (IVDs) for marketing approval in Tanzania.

He has been involved in the development of national policies, regulations, and technical guidelines related to the regulation of medical products. As part of his regulatory responsibilities, he has conducted quality audits both locally and internationally, ensuring compliance with ISO 13485 standards.

He has served as the WHO Collaborative Procedure focal point for in vitro diagnostics in Tanzania and represents the country as the SADC regional focal person for the harmonisation of medical device regulation. He is also an active member of the GHWP Technical Working Group WG3 – Pre-market: Software as Medical Device.