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Clay & Associates Advocates is a Nairobi corporate and commercial law firm. We advise founders, investors and established companies on transactions, disputes, regulation and the protection of what they create.
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Regulatory & Compliance
Software as a Medical Device: Where Kenya’s Current Framework Falls Short
The Pharmacy and Poisons Board’s new guideline on medical device software gives Kenya real, detailed rules for AI-enabled health tools for the first time.…
Life Sciences & HealthcareRegulating AI-Enabled Medical Devices: A Preview of What’s Coming to the PPBThe Pharmacy and Poisons Board published its Guideline on Regulation of Medical Device Software in Kenya on 16…2 Sep 2026- Intellectual PropertymRNA Technology Transfer: Legal Lessons for Kenya from the Afrigen and WHO Hub ProgrammesKenya BioVax Institute signed its technology transfer agreement with the Medicines Patent Pool on 25 September 2024, and…2 Sep 2026
- Regulatory & ComplianceWhat African Medicines Agency Ratification Means for Registering Products Across AfricaKenya ratified the treaty establishing the African Medicines Agency in November 2023, and the Agency itself was formally…2 Sep 2026
- Regulatory & ComplianceThe Assisted Reproductive Technology Bill: Licensing Fertility Clinics and Regulating Surrogacy in KenyaKenya’s Assisted Reproductive Technology Bill would create the country’s first dedicated licensing regime for fertility clinics and its…2 Sep 2026
- Regulatory & ComplianceAccess and Benefit Sharing Under the Nagoya Protocol: A Guide for Bioprospecting and Natural-Compound Sourcing in KenyaKenya ratified the Nagoya Protocol on access to genetic resources in 2014, and the domestic rules implementing it…2 Sep 2026
