Successfully navigating the Philippine Food and Drug Administration (FDA – Center for Device Regulation, Radiation Health, and Research) requires far more than checklist compliance—it demands deep institutional knowledge, technical precision, and strategic foresight.
Tricraden delivers specialized advisory and execution in medical device regulatory compliance across the Philippine healthcare sector. Our hands-on practice spans the entire product lifecycle—from complex technical dossier compilation and local establishment licensing to high-risk product authorizations and post-market vigilance.
Decades of dedicated regulatory affairs practice in the Philippine market
Proven track record securing hundreds of successful LTO, CMDN, and CMDR approvals
Comprehensive mastery of ASEAN Medical Device Directive (AMDD) and Common Submission Dossier Template (CSDT) standards
Initial & Renewal LTO: Complete application management for Medical Device Importers, Wholesalers, Distributors, and Manufacturers.
Technical Compliance: Guidance on Qualified Personnel (Pharmacist/Regulatory Officer) regulatory responsibilities.
Facility & Storage Readiness: Pre-inspection facility and warehouse assessments to ensure seamless FDA audit compliance.
Risk Classification: Accurate grouping under AO 2018-0002 and AMDD guidelines (Risk Classes A, B, C, and D).
CSDT Dossier Compilation: Complete assembly and rigorous technical gap analysis before official submission.
Submission Management: Active liaison and prompt response handling for FDA technical inquiries and notices.
Variations & Amendments: Fast-track filing for labeling changes, shelf-life extensions, and packaging modifications.
Proactive License Renewals: Structured monitoring to prevent commercial disruptions and supply chain delays.
Adverse Event Vigilance: Compliant local reporting frameworks aligned with national vigilance guidelines.
GDPMD Alignment: Structuring warehousing, storage, and traceability to meet Good Distribution Practices for Medical Devices.
Internal Compliance Audits: Identifying critical gaps prior to official CDRRHR regulatory inspections.
Corrective Actions (CAPA): Practical resolution planning for regulatory observations and audit findings.
Hundreds of successful regulatory authorizations and establishment clearances secured across diverse device classes.
Thorough CSDT technical audits before submission, significantly cutting down on review cycles and deficiency notices.
From initial classification to post-market renewals, we manage the entire regulatory pipeline so you can focus on commercial growth.
Portfolio Classification & Strategy: We review your product technical sheets, intended use, and indications to determine the correct risk tier and fastest regulatory path.
Dossier Audit & CSDT Assembly: We translate foreign certifications (CE, US FDA, PMDA, TGA) into Philippine FDA–compliant technical dossiers.
FDA Filing & Active Follow-Through: We submit through the official FDA e-portal and handle all technical inquiries directly with reviewers.
Clearance Issuance & Handover: You receive your official registration and an automated roadmap for maintenance, variations, and renewals.
Whether you are an international manufacturer seeking market authorization or a local distributor expanding your medical portfolio, get in touch to discuss your regulatory pipeline.
Email: contact@tricraden.com
Location: Metro Manila, Philippines