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Guideline on Regulation of Medical Device Software in Kenya (MDSW)

Guideline on Regulation of Medical Device Software in Kenya (MDSW)

Overview

This guideline by the Pharmacy and Poisons Board (PPB) provides a framework for regulating Medical Device Software (MDSW), including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

What This Guideline Covers

Risk classification of medical software

Cybersecurity and data protection requirements

AI and Machine Learning considerations

Documentation and approval requirements

Interoperability with digital health systems

Regulatory Approach

Risk-based regulation aligned to patient safety

Harmonized with international frameworks (IMDRF, WHO)

Lifecycle oversight from approval to post-market monitoring

Why It Matters

Protects patient safety

Supports innovation in digital health

Enhances access to healthcare technologies

Provides clear regulatory guidance

Who Should Use It

Medical device manufacturers

Software developers

Healthcare providers

Regulatory professionals

Attached Files