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Kenya

PPB (Pharmacy and Poisons Board) ยท Import documentation

PPB registration for
medical devices in Kenya.

Medical devices imported into Kenya are regulated by the Pharmacy and Poisons Board (PPB). Product registration is held by the Kenyan importer of record. SWIFTSKY supplies the full technical documentation package for your application.

Documentation Required from SWIFTSKY

  • Free Sale Certificate (CDSCO)
  • ISO 13485 certificate (current)
  • CE certificate (where applicable)
  • Manufacturing licence
  • Technical file / product dossier
  • Pre-shipment inspection report (SGS/BV/TรœV/Intertek)

Honest timeline note: PPB first-time product registration typically takes 3โ€“6 months. Registration is the buyer's responsibility. We support with complete documentation.

Products in Demand in Kenya

Examination Gloves Surgical Gloves Disposable Syringes Wound Dressings

Quick reference

Regulator: PPB Kenya
Registration: Buyer holds it
Timeline: 3โ€“6 months first-time
Request a Kenya Quote โ†’

Import to Kenya.

Full PPB documentation pack supplied with every shipment.