Medical Device Act (RA 9711) and CDRRHR — Philippine Regulatory Framework
The Philippine Food and Drug Administration (FDA), operating through its Center for Device Regulation, Radiation Health and Research (CDRRHR), regulates medical devices under Republic Act 9711 (FDA Act of 2009) and its implementing rules. All medical devices must be classified under the ASEAN harmonised risk-based framework (Class A, B, C, or D) and either registered (CMDR) or notified (CMDN) before they may be lawfully marketed in the Philippines.
Key requirements include:
- CMDN for Class A (lowest-risk) devices — notification process with lighter documentation.
- CMDR for Class B, C, and D devices — full technical documentation, clinical evidence proportionate to class, and quality system evidence.
- A License to Operate (LTO) for all establishments manufacturing, importing, distributing, or selling medical devices.
- Post-market obligations including adverse event reporting and product recall coordination with CDRRHR.
📅 Effective / published: RA 9711 — 2009; ASEAN AMDD harmonisation ongoing
Manufacturers and importers must appoint a Philippine-based establishment licence holder responsible for CDRRHR submissions. Ensure all product classification, technical documentation, and labelling comply with current CDRRHR guidance before filing. Check CDRRHR's online portal (PRISM) for current fee schedules and application forms.
View official source (Philippine FDA — Medical Devices) ↗