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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