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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).

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
  • CDRRHR Operations — LTO, compliance and enforcement, emergency provisions
  • Post-Market — vigilance, recalls, PMS, CMDN/CMDR maintenance, labelling
  • Legislation — RA 9711, RA 3720, Administrative Orders, FDA Circulars, ASEAN instruments
  • Guidance & Resources — CSDT templates, fee schedule, administrative orders index

Part of the RAPath suite.