Medical Devices Regulatory & Cybersecurity Compliance Assessment Services in Philippines

Medical Devices Compliance Assessment Philippines

Introduction

The Philippines is rapidly strengthening its healthcare and digital health ecosystem, with increasing adoption of connected medical devices, cloud-based clinical platforms, and software-driven diagnostics. As innovation accelerates, regulatory authorities are expanding their focus beyond traditional safety and quality to include cybersecurity resilience, data privacy, and software reliability.

Cyberintelsys provides medical devices regulatory and cybersecurity compliance assessment services in the Philippines, helping manufacturers, importers, and digital health providers align with Food and Drug Administration (FDA) Philippines requirements while meeting international standards and CREST-aligned cybersecurity expectations.

Medical Device Regulatory Landscape in the Philippines

Medical devices in the Philippines are regulated by the Food and Drug Administration (FDA Philippines) under the Department of Health. Current regulatory priorities include:

  • Risk-based device classification and product registration

  • Licensing of manufacturers, importers, and distributors

  • Compliance with safety, performance, and quality requirements

  • Software validation and cybersecurity considerations

  • Post-market surveillance and adverse event reporting

With the growth of software as a medical device (SaMD) and network-connected products, regulators increasingly expect evidence of secure design and cyber risk management.

Emerging Compliance Challenges for Medical Device Companies

Medical device organizations operating in the Philippines commonly face:

  • Managing evolving FDA guidance for software-enabled devices

  • Demonstrating cybersecurity controls during registration and audits

  • Protecting patient data in connected healthcare environments

  • Aligning local compliance with global regulatory frameworks

  • Maintaining compliance during software updates and device changes

Cyberintelsys addresses these challenges through an integrated regulatory and cybersecurity compliance model.

Cyberintelsys Integrated Compliance Assessment Services

1. Regulatory Readiness & Gap Assessment

Cyberintelsys evaluates product readiness by assessing:

  • Device classification and approval pathways

  • Regulatory documentation completeness

  • Labeling, language, and instructions for use compliance

  • Risk management and safety evidence

This reduces approval delays and minimizes regulatory rework.

2. International Standards & Quality Alignment

We support alignment with globally recognized standards, including:

  • ISO 13485 – Medical Device Quality Management Systems

  • ISO 14971 – Medical Device Risk Management

  • IEC 62304 – Medical Device Software Lifecycle

  • IEC 60601 – Electrical Safety and Performance

  • IEC 81001-5-1 – Health Software Cybersecurity

This strengthens regulatory acceptance and supports international market expansion.

3. CREST-Aligned Medical Device Cybersecurity Assessment

Cybersecurity is now a critical component of medical device compliance. Cyberintelsys delivers:

  • Secure architecture and design reviews

  • Threat modeling for connected medical devices

  • CREST-aligned penetration testing

  • Vulnerability identification and remediation guidance

  • Secure update and patch management assessment

CREST-aligned testing provides trusted and regulator-ready security assurance.

4. Software as a Medical Device (SaMD) Compliance

For digital health and software-centric products, we assess:

  • Software safety classification and lifecycle governance

  • Secure development and release practices

  • Data integrity and availability controls

  • Cloud and third-party dependency risks

This ensures safe, compliant, and resilient software deployment.

5. Data Privacy & Patient Information Protection

Medical devices handling health data must comply with the Philippines Data Privacy Act (DPA). Cyberintelsys supports:

  • Privacy-by-design implementation

  • Secure data transmission and storage

  • Role-based access and audit logging

  • Breach readiness and response planning

This protects patient trust and reduces regulatory exposure.

6. Post-Market Surveillance & Continuous Compliance

Cyberintelsys provides ongoing compliance support through:

  • Post-market performance and cyber risk monitoring

  • Regulatory audit and inspection readiness

  • Incident and vulnerability response planning

  • Periodic reassessment following updates or changes

This ensures long-term compliance across the device lifecycle.

Why Choose Cyberintelsys in the Philippines?

  • Combined regulatory, software, and cybersecurity expertise

  • CREST-aligned security assurance for healthcare technologies

  • Experience supporting FDA Philippines compliance requirements

  • Practical, implementation-focused assessments

  • Reduced compliance risk and faster market confidence

Cyberintelsys serves as a single trusted compliance partner from market entry through post-market operations.

Key Benefits of Integrated Compliance Assessment

  • Faster medical device approvals

  • Reduced regulatory and cybersecurity risk

  • Stronger patient safety and data protection

  • Improved trust with regulators and healthcare providers

  • Sustainable compliance in a rapidly evolving market

Conclusion

As the Philippines accelerates digital health adoption, medical device compliance must extend beyond basic regulatory approval to include cybersecurity resilience, software governance, and data privacy protection.

Cyberintelsys’ medical devices regulatory and cybersecurity compliance assessment services in the Philippines, supported by CREST-aligned cybersecurity assurance, empower organizations to deliver secure, compliant, and future-ready medical technologies to the Philippine healthcare ecosystem.

Reach out to our professionals

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