Kenya has a robust and structured product compliance system that emphasizes import quality control, mandatory standards, and public health protection. Many products must undergo Pre-Export Verification of Conformity (PVoC) and be certified before entry into the country.

Key Authorities:

• Kenya Bureau of Standards (KEBS) – Develops and enforces Kenya Standards (KS), issues Standardization Marks, and manages the PVoC program.

• Pharmacy and Poisons Board (PPB) – Regulates pharmaceuticals, medical devices, and health-related products, including licensing and market surveillance.

• Kenya Medical Supplies Authority (KEMSA) – Manages public procurement and quality oversight of medical commodities.

• Communications Authority of Kenya (CAK) – Oversees type approval for telecom, wireless, and RF equipment.

• Kenya Revenue Authority (KRA) – Customs agency that verifies import documentation and enforces border compliance.

Key Compliance Elements:

• Pre-Export Verification of Conformity (PVoC):

  • Mandatory for most regulated goods.

  • Conducted by KEBS-appointed bodies (e.g., SGS, Bureau Veritas, Intertek) in the exporting country.

  • Products must meet Kenya Standards or international equivalents (e.g., ISO/IEC).

  • A Certificate of Conformity (CoC) is required for customs clearance.

• Standardization Mark (SM):

  • Required for locally manufactured goods and sometimes for imported goods sold in bulk or retail.

  • Issued after product testing and factory inspection.

• Product Registration:

  • Pharmaceuticals, medical devices, and cosmetics must be registered with the Pharmacy and Poisons Board.

  • Submission includes technical documentation, safety data, GMP compliance, and sample testing.

• Telecom Type Approval:

  • All telecom and RF equipment must be type approved by CAK before use or sale.

  • Products with FCC or CE certification may receive simplified review but must still be formally registered.

• Labeling Requirements:

  • Labels must be in English or Kiswahili, and include:

    • Product name

    • Country of origin

    • Manufacturer/importer contact

    • Usage instructions

    • Expiry date (if applicable)

    • Certification mark (CoC or SM)

    • Safety warnings and batch/lot number

• Import Requirements:

  • At the border, importers must submit:

    • Certificate of Conformity (CoC)

    • Invoice and packing list

    • Certificate of origin

    • Regulatory permits (for restricted goods)