The Philippine Food and Drug Administration (FDA) has released for public comment a Draft Administrative Order that will establish the rules and requirements for conducting Clinical Investigation (CI) of Medical Devices and Clinical Performance Studies (CPS) of In-Vitro Diagnostic (IVD) Medical Devices in the Philippines. Stakeholders are invited to submit

The Philippines Department of Health has issued Administrative Order (AO) 2025-0030, formally adopting the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD). This AO establishes the mandatory post-market surveillance framework for medical devices in the Philippines, ensuring continued safety, performance, and quality following

The Food and Drug Administration (FDA) has officially launched the eSUMBONG system, a new online reporting mechanism integrated into its updated website. This initiative marks a significant advancement in regulatory enforcement, providing the public with a streamlined and secure channel to lodge complaints or report violations concerning FDA-regulated products. By