Areas of Expertise

Our Sectors

Three specialized domains where deep regulatory knowledge meets practical experience — ensuring your products meet every standard required for market entry.

Medical Devices

Navigating Kenya's Medical Device Regulatory Landscape

Medical devices in Kenya are regulated by the Pharmacy and Poisons Board (PPB), which requires systematic registration and approval before any device can be distributed or used. The process involves device classification, technical dossier submission, and compliance with applicable international standards.

Our team has extensive experience in PPB medical device registration across all risk classes — from simple Class A devices to high-risk Class D implantables. We support both local manufacturers and international companies seeking market access in Kenya and the wider East African Community.

Our Medical Device Services Include:

  • Device classification under PPB / GHTF framework
  • Technical documentation and dossier preparation
  • ISO 13485 quality management gap analysis
  • PPB product registration and renewal
  • Post-market surveillance system setup
  • Incident and vigilance reporting support
  • In-vitro diagnostic (IVD) registration
  • Import permits and distribution authorization
Regulatory Framework
Lead Authority Pharmacy & Poisons Board (PPB), Kenya
Standards Applied ISO 13485, IEC 62304, ISO 14971, GHTF Guidelines
Device Classes Class A (Low Risk) to Class D (High Risk)
Typical Timeline 3–18 months depending on device class
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Food Supplements

Bringing Nutraceuticals to Market Legally

Food supplements, nutraceuticals, and fortified food products require registration and approval from KEBS (Kenya Bureau of Standards) before they can be legally marketed in Kenya. Products must meet compositional standards, labeling requirements, and safety criteria set out under the Food, Drugs and Chemical Substances Act.

Navigating KEBS, KEPHIS, and the Kenya Food and Drugs Authority requirements simultaneously can be complex. Marsland simplifies this by providing complete end-to-end regulatory management for your supplement products — from formulation review to shelf approval.

Our Food Supplement Services Include:

  • Product classification and regulatory pathway mapping
  • KEBS Standards Mark certification support
  • KEPHIS phytosanitary requirements for botanical products
  • Nutritional label design and compliance review
  • Novel ingredient safety assessment coordination
  • Health claim substantiation and review
  • Import and export regulatory documentation
  • Shelf-life and stability study guidance
Regulatory Framework
Lead Authorities KEBS, KEPHIS, Kenya Food Safety Authority
Standards Applied KS 1700, Codex Alimentarius, EAC Food Standards
Product Types Vitamins, Minerals, Herbals, Probiotics, Protein Supplements
Typical Timeline 2–8 months depending on product complexity
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Cosmetics

Cosmetics Compliance — Beauty Meets Regulation

Cosmetic products in Kenya are regulated under the Kenya Cosmetics Regulation, overseen by the Kenya Pharmacy and Poisons Board and aligned with EAC Cosmetics Regulations. All cosmetics — from skincare and haircare to makeup and fragrances — must be notified before market entry.

Our cosmetics regulatory team brings deep knowledge of KPRA notification procedures, EAC Cosmetics Regulations, and international cosmetic safety standards. We ensure your products not only enter the market but maintain ongoing compliance.

Our Cosmetics Services Include:

  • EAC Cosmetics Regulation notification management
  • KPRA product registration and notification
  • Cosmetic Safety Report (CSR) coordination
  • INCI ingredient list review and compliance check
  • Prohibited and restricted substances screening
  • Label and claim compliance review
  • Preservative challenge test guidance
  • Product information file (PIF) preparation
Regulatory Framework
Lead Authorities KPRA, PPB Kenya, EAC
Standards Applied EAC/FDAC/TC 01/TS 001, ISO 22716 GMP
Product Categories Skincare, Haircare, Makeup, Fragrance, Oral Hygiene
Typical Timeline 1–6 months for notification and approval
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