Medical devices in Kenya are regulated by the Pharmacy and Poisons Board (PPB) and the Kenya Bureau of Standards (KEBS). Regulation has been progressively strengthened in recent years.
Device Classification
Medical devices are classified based on risk profile. Class I (low risk, such as bandages) has lighter requirements. Class II (moderate risk, such as sutures) requires more extensive documentation. Class III (high risk, including implantable devices) is subject to the most stringent requirements. In vitro diagnostics have a separate classification system.
Registration Requirements
Importers and local manufacturers of regulated medical devices must register products with the PPB before placing them on the market. The registration dossier includes technical documentation, clinical data, and labelling complying with Kenyan requirements. Post-market surveillance obligations include adverse event reporting.
KEBS Standards Compliance
KEBS enforces Kenyan Standards for medical devices. Standards compliance is mandatory for devices covered by gazette notices. Non-compliant devices can be seized, and the importer or distributor prosecuted.
Public Procurement
A significant portion of the medical devices market is driven by public sector procurement through the Ministry of Health and county governments. Suppliers to government programmes must meet KEMSA standards and comply with the Public Procurement and Asset Disposal Act.
Importing or distributing medical devices in Kenya? Contact Clay & Associates Advocates. Book a Consultation
