Philippines FDA Medical Device Registration
Cisema supports your complete journey toward Philippines medical device registration, offering early-stage planning, risk classification, technical documentation review, and quality inspections. From initial regulatory assessment and documentation review to registration readiness and market entry support, Cisema helps foreign manufacturers navigate Philippines medical device regulations.
Whether registering lower-risk Class A or moderate- to higher-risk Class B, C, or D devices, preparing for an ASEAN-wide rollout, or conducting a risk analysis before submitting a new registration, Cisema provides structured support to meet Philippines FDA requirements and streamline your registration process.
Philippines Healthcare Market Overview
The Philippines is one of Southeast Asia’s most promising healthcare markets, with over 113 million people and a growing urban population that is fueling demand for quality devices and diagnostics. With more than 1,800 hospitals and expanding rural health units, the country presents a compelling opportunity for foreign manufacturers preparing for long-term market entry.
Navigating the Philippines medical device registration process, regulated by the Philippines Food and Drug Administration (FDA) under the Department of Health, is essential for manufacturers seeking market access. From device regulation to submission planning, understanding the evolving regulatory framework is key to success, especially as the country aligns with the ASEAN Medical Device Directive.
Our Services for IVD & Medical Device Registration in the Philippines
Cisema offers comprehensive support for medical device and IVD manufacturers entering the Filipino market ensuring they are fully aligned with ASEAN Medical Device Directive and local requirements.
Regulatory Strategy & Classification
Documentation Readiness & Feasibility Analysis
Regulatory Intelligence & Local Adaptation
Strategic ASEAN Integration
Ongoing Regulatory Intelligence & Alerts
Medical Device Change Management & Post-Market Surveillance Services
Cisema provides regulatory change management and post-market surveillance support for medical devices in the Philippines, helping manufacturers manage registration and ongoing regulatory compliance.
Device Change & PMS Impact Assessment
Regulatory Change & Compliance Support
Regulatory Intelligence & Impact Assessment
Post-Market Safety & Vigilance
Quality Control Inspection Services for Medical Devices & IVDs in the Philippines
Cisema provides third-party inspections to support your Philippines medical device and IVD operations. Whether importing, assembling, or preparing for audits, we help validate compliance with Philippines FDA and international standards.
Incoming Goods Inspections
In Process Monitoring
Final Product Inspection
Custom Audits
Why Work with Cisema?
Local expertise with global reach
Our bilingual teams bridge international quality standards with local regulations
Proven track record
Over 20 years supporting market approvals and compliance in China and Asia Pacific
End-to-end solutions
From system setup to post-market surveillance, we ensure quality management and regulatory compliance throughout the product lifecycle
Industry breadth
Cross-sector expertise in life sciences, food, veterinary, consumer and industrial goods
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