Medical Devices Regulatory Framework & Update: Republic of Kenya (November 2022)

46 pages. The Republic of Kenya is a promising and fastest-growing market for medical devices in the sub-Saharan Africa region despite the challenges faced by the importers to penetrate the Kenyan market. All imported medical devices are regulated by the Pharmacy and Poisons Board (PPB) and fall under the regulations of Kenya Law Pharmacy and Poison Act Chapter 244. It is important to note that for market authorization, the medical device must be registered following the requirements established by the PPB and subjected to pre-export verification of conformity to standards through a programme implemented by the Kenya Bureau of Standards (KEBS) for importation. However, the PPB is currently moving towards removing requirements for PVoC and associated licensing to ease the importation process. Also, to increase the quality, safety, and efficacy of health products and technologies in Kenya, the mobile Pharmacovigilance Electronic Reporting System (mPvERS) platform was introduced. The mPvERS platform will strengthen the reporting and vigilance on safety quality issues for health products and technologies by healthcare providers and the general public.