End-to-End Medical Devices Regulatory Compliance Assessment Services in Cambodia

Medical Devices Compliance Assessment | Cambodia

Introduction

Cambodia’s healthcare ecosystem is rapidly modernizing, driven by increased adoption of medical devices, digital health platforms, and connected diagnostic technologies. As hospitals, clinics, and manufacturers introduce advanced medical devices into the Cambodian market, regulatory compliance and cybersecurity assurance have become inseparable requirements.

Medical device companies must now navigate Cambodia’s Ministry of Health (MoH) regulations and growing expectations around data protection, device safety, and cyber resilience. Cyberintelsys delivers end-to-end Medical Devices Regulatory Compliance Assessment Services in Cambodia, combining regulatory expertise with CREST-aligned cybersecurity testing and risk assurance ensuring devices are safe, secure, and market-ready.

Cambodia Medical Device Regulatory Landscape – What’s Changing?

Cambodia regulates medical devices through the Department of Drugs and Food (DDF), Ministry of Health, with increasing alignment to ASEAN Medical Device Directive (AMDD) principles. Key regulatory expectations include:

  • Product registration and licensing with MoH

  • Technical documentation and conformity assessment

  • Quality management system compliance (ISO 13485 alignment)

  • Post-market surveillance and vigilance reporting

  • Data protection and patient safety controls for software-enabled devices

With the rise of software as a medical device (SaMD), IoMT, and cloud-connected devices, regulators are placing stronger emphasis on cybersecurity risk management as part of compliance readiness.

Why Cybersecurity Is Now Critical for Medical Device Compliance

Modern medical devices process sensitive patient data and often connect to hospital networks or cloud platforms. Regulatory bodies increasingly expect manufacturers to demonstrate:

  • Secure device design and architecture

  • Protection against unauthorized access and data breaches

  • Risk-based vulnerability management

  • Secure software lifecycle controls

  • Resilience against cyber threats impacting patient safety

Cyberintelsys integrates regulatory compliance and cybersecurity assurance into a single assessment framework, reducing approval delays and minimizing regulatory risk.

Cyberintelsys End-to-End Compliance Assessment Approach

1. Medical Device Regulatory Gap Assessment (Cambodia Focus)

We evaluate your device against Cambodia MoH and ASEAN-aligned regulatory requirements, covering:

  • Device classification and registration pathway

  • Technical file and clinical evaluation readiness

  • Labeling, IFU, and language compliance

  • Quality system documentation review

  • Post-market surveillance obligations

This ensures your product is regulatory-ready before submission, reducing rejection and rework.

2. Cybersecurity Risk Assessment for Medical Devices

Cyberintelsys conducts in-depth cybersecurity assessments aligned with global best practices, including:

  • Threat modeling for connected medical devices

  • Secure firmware and software architecture review

  • Data integrity and encryption assessment

  • Access control and authentication validation

  • Secure update and patch management review

Our assessments align with international cybersecurity expectations increasingly referenced by regulators.

3. CREST-Aligned Penetration Testing & Assurance

To strengthen regulatory and stakeholder confidence, Cyberintelsys delivers CREST-aligned penetration testing services, covering:

  • Medical device software and applications

  • APIs and cloud-connected platforms

  • Hospital network integration points

  • Mobile health applications linked to devices

This demonstrates independent, structured security validation, supporting regulatory submissions and customer trust.

4. SaMD & Digital Health Compliance Assessment

For Software as a Medical Device (SaMD) and digital health solutions, we assess:

  • Software lifecycle and risk controls

  • Data privacy and patient data protection

  • Secure cloud deployment architecture

  • Interoperability and integration risks

This ensures both functional safety and cybersecurity compliance for Cambodia market entry.

5. Regulatory Documentation & Submission Support

Cyberintelsys supports end-to-end documentation preparation, including:

  • Regulatory compliance reports

  • Cybersecurity risk and mitigation documentation

  • Technical file alignment for MoH submission

  • Audit-ready evidence and traceability matrices

Our structured approach simplifies interactions with regulators and notified stakeholders.

Why Choose Cyberintelsys for Cambodia Medical Device Compliance?

  • Integrated regulatory + cybersecurity expertise

  • Cambodia MoH and ASEAN-aligned assessment approach

  • CREST-aligned penetration testing capabilities

  • Experience across medical devices, SaMD, and IoMT

  • Risk-based, audit-ready compliance reporting

  • Faster market access with reduced regulatory friction

We don’t just assess compliance—we help you build regulatory confidence and cyber resilience from design to deployment.

Who We Support

  • Medical device manufacturers entering Cambodia

  • Digital health and SaMD providers

  • Hospitals deploying connected medical technologies

  • Distributors and importers requiring compliance validation

  • Healthcare innovators expanding across ASEAN markets

Conclusion

As Cambodia advances its healthcare infrastructure, medical device compliance is no longer limited to paperwork it demands cybersecurity, resilience, and patient safety assurance. Cyberintelsys delivers end-to-end Medical Devices Regulatory Compliance Assessment Services in Cambodia, combining regulatory insight with CREST-aligned cybersecurity validation to help organizations enter the market confidently, securely and compliantly.

Reach out to our professionals

[email protected]