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Philippines Medical Device Regulation

Regulatory authority: FDA Philippines / Center for Device Regulation, Radiation Health and Research (CDRRHR) | Legislation: RA 9711 (FDA Act of 2009), DOH Administrative Orders | Last reviewed: May 2026 | For reference only — not legal advice.

The Philippines regulates medical devices through the Center for Device Regulation, Radiation Health and Research (CDRRHR) — a center within FDA Philippines under the Department of Health (DoH). The framework combines the FDA Act of 2009 (RA 9711) with Administrative Orders, and is aligned with the ASEAN Medical Device Directive (AMDD).

Regulatory Pathway Map​

Click a phase to expand — each card links to the relevant section of this guide.

Getting Started
What is a Medical Device?
Legal definition under RA 9711 and the FDA Act of 2009 — scope, exclusions, and key terms.
Read definition →
Getting Started
Regulatory Framework
How CDRRHR and FDA Philippines are structured and which laws govern medical devices.
View framework →
Getting StartedKey step
Who Must Comply?
LTO and CDN/CDR obligations for manufacturers, importers, traders, and distributors.
Check obligations →

Key Facts​

Regulatory bodyFDA Philippines / CDRRHR (under DoH)
Primary lawRA 9711 — Food and Drug Administration Act of 2009; DOH AO 2018-002
ClassificationClass A (low) · B · C · D (high) — ASEAN AMDD
Class A pathwayCMDN — Certificate of Medical Device Notification
Class B/C/D pathwayCMDR — Certificate of Medical Device Registration
Abridged routeFDA Circular 2022-008 — 30 working days via ASEAN NRA reliance
IVDsCurrently NOT required to register — upcoming regulation pending
LTOLicense to Operate — mandatory for all manufacturers, importers, distributors
Deficiency period90 calendar days to address application deficiencies
ASEAN alignmentFull ASEAN AMDD + CSDT participant

What This Site Covers​

  • Getting Started — definitions, CDRRHR/FDA structure, ASEAN alignment, IVD status, who must comply
  • Classification — ASEAN AMDD Class A–D, IVD exception, product classification inquiry
  • CMDN & CMDR — Class A notification, Class B/C/D registration, abridged pathway, technical documentation
  • Pre-Market — technical documentation, CSDT structure, clinical evidence by class, special device types
  • CDRRHR Operations — LTO, compliance and enforcement, emergency provisions
  • Quality System — ISO 13485 requirements, GDP, CDRRHR inspections
  • Post-Market — vigilance, recalls, PMS plan, CMDN/CMDR maintenance, labelling
  • Digital Health — MDSW/SaMD framework, IEC 62304, cybersecurity (draft circular 2025)
  • Legislation — RA 9711, RA 3720, Administrative Orders, FDA Circulars, ASEAN instruments
  • Guidance & Resources — eServices portal, CSDT templates, fee schedule, administrative orders index

Part of the RAPath suite.