Introduction

Kenya is emerging as a regional healthcare and medical technology hub in East Africa, with increasing adoption of digital health platforms, connected medical devices, and locally assembled equipment. As the ecosystem grows, regulatory authorities are placing stronger emphasis not only on device safety and quality, but also on cybersecurity, data protection, and software integrity.

Cyberintelsys provides medical devices regulatory and cybersecurity compliance assessment services in Kenya, helping manufacturers, importers, and healthcare technology providers meet Pharmacy and Poisons Board (PPB) requirements while aligning with international standards and CREST-aligned cybersecurity testing.

Medical Device Regulatory Environment in Kenya

Medical devices in Kenya are regulated by the Pharmacy and Poisons Board (PPB) under the Ministry of Health. Key regulatory expectations include:

• Medical device registration and market authorization

• Risk-based device classification

• Compliance with essential safety and performance principles

• Local authorized representative requirements

• Post-market surveillance and vigilance obligations

With the rise of software-driven and network-connected devices, cybersecurity has become a growing regulatory concern during approvals and audits.

Key Compliance Challenges for Medical Device Companies in Kenya

Manufacturers and distributors often encounter:

• Navigating PPB registration timelines and documentation

• Demonstrating alignment with ISO, IEC, and international benchmarks

• Managing cybersecurity risks in connected and cloud-enabled devices

• Protecting patient and clinical data

• Maintaining compliance during software updates and device modifications

Cyberintelsys addresses these challenges through an integrated regulatory and security-focused assessment model.

Cyberintelsys End-to-End Compliance Assessment Services

1. Medical Device Regulatory Readiness Assessment

Cyberintelsys conducts structured gap assessments covering:

• Device classification and approval pathway

• Technical file and conformity documentation

• Labeling, instructions for use, and language compliance

• Risk management and clinical evidence readiness

• Importer and distributor compliance alignment

This ensures smoother PPB submissions and fewer regulatory queries.

2. International Standards & Best Practice Alignment

We help align medical devices with globally recognized standards, including:

• ISO 13485 – Medical Device Quality Management Systems

• ISO 14971 – Risk Management for Medical Devices

• IEC 62304 – Medical Device Software Lifecycle

• IEC 60601– Electrical Safety and Performance

• IEC 81001-5-1 – Health Software Cybersecurity

This alignment strengthens regulatory acceptance in Kenya and supports regional and global market access.

3. CREST-Aligned Medical Device Cybersecurity Testing

As cyber threats increasingly target healthcare infrastructure, Cyberintelsys delivers CREST-aligned cybersecurity assessments tailored to medical devices, including:

• Secure architecture and design reviews

• Threat modeling for connected devices

• Penetration testing of device firmware, APIs, mobile apps, and cloud platforms

• Vulnerability identification and remediation guidance

• Cyber risk reporting aligned with regulatory expectations

CREST-aligned testing provides trusted assurance for regulators, healthcare providers, and partners.

4. Software as a Medical Device (SaMD) Compliance

For digital health solutions and SaMD products, Cyberintelsys evaluates:

• Software safety classification

• Secure development lifecycle controls

• Data integrity and availability measures

• Third-party and cloud service risks

• Change management and version control

This helps ensure compliance across the full software lifecycle.

5. Data Protection & Patient Privacy Compliance

Medical devices processing health data must align with Kenya’s Data Protection Act, 2019, including:

• Lawful data collection and processing

• Data minimization and retention controls

• Secure data transmission and storage

• Role-based access and audit logging

Cyberintelsys integrates privacy-by-design principles into medical device compliance assessments.

6. Post-Market Surveillance & Ongoing Compliance Support

Compliance does not stop after approval. We support:

• Post-market cybersecurity monitoring

• Incident and vulnerability response planning

• Regulatory audit readiness

• Periodic compliance reassessments

• Secure software update impact analysis

This ensures sustained compliance and operational resilience.

Why Choose Cyberintelsys in Kenya?

• Combined regulatory and cybersecurity expertise

• CREST-aligned security testing methodologies

• Experience with PPB regulatory frameworks

• Support for manufacturers, importers, and distributors

• Reduced approval delays and compliance risks

Cyberintelsys acts as a single trusted partner across regulatory, quality, and cybersecurity domains.

Benefits of Integrated Compliance Assessment

• Faster medical device approvals in Kenya

• Stronger cybersecurity posture

• Reduced risk of regulatory non-compliance

• Improved patient safety and data protection

• Increased trust with healthcare stakeholders

Conclusion

As Kenya advances its healthcare infrastructure and digital health capabilities, medical device manufacturers must ensure compliance extends beyond basic registration to include software safety, cybersecurity resilience, and data protection.

Cyberintelsys’ medical devices regulatory and cybersecurity compliance assessment services in Kenya, backed by CREST-aligned assurance, help organizations confidently deliver secure, compliant, and future-ready medical technologies to the Kenyan healthcare ecosystem.