Kenya Medical Device Regulations

Agency

All medical devices are regulated by the Drug Policy and Planning Center (DPPC) and the Central Administration of Pharmaceutical Affairs (CAPA).

Classification of Medical Device

International Classification	Examples	Risk Level
A	Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale	Low
B	Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask	Low - Moderate
C	Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens	High - Moderate
D	HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker	High

Premarket Approval Process

Class A	Class B	Class C	Class D
It is recommended that applicant appoints a local representative.
Fill out application form and submit all required documents (listed below).
If approved, applicant will receive a registration certificate

List of Required Documents

CFS
Quality system certification
Declaration of conformity
Description of device and intended use
Clinical and preclinical data

Additional Information

Validity	Valid for 1 year
Postmarket Surveillance	Sampling, monitoring, and vigilance controls in place.

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