Nairobi, Kenya – Africa is making progress towards harmonised regulation of medical devices and in vitro diagnostic devices (IVDs), with initiatives supporting common requirements and greater reliance on trusted regulatory decisions.

At Afri Summit 2026 on 1st October, Dr. Pauline Wairimu, Head of Medical Devices at the Pharmacy and Poisons Board (PPB), highlighted the contribution of the AMRH Initiative, the African Medical Devices Forum and the African Medicines Agency (AMA).

She noted that regulatory fragmentation, capacity gaps and weak post-market surveillance remain challenges. Strengthening regulatory oversight, expanding digital systems, supporting local manufacturing and building sustainable regulatory capacity are essential to improving access to safe, quality-assured medical devices and IVDs across Africa.