The Medical Device Authority (MDA) has conducted laboratory testing on six (6) types of medical devices as part of its market surveillance activities. ECRI Berhad was appointed as the testing laboratory to carry out technical and performance evaluations of the identified medical devices based on the descriptions of complaints received.
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
Following the Ministry of Public Health Notification B.E. 2562 (2019) regarding alcohol-containing products intended for disinfection of humans, animals, and medical devices, the Medical Device Control Division has undertaken a comprehensive review of such products. This review included the issuance of notification certificates and the evaluation of supporting documentation required
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
The Health Sciences Authority (HSA) has introduced a series of regulatory initiatives aimed at strengthening oversight of medical devices while promoting innovation and timely patient access. The updates cover software and AI-enabled medical devices, dealer licensing requirements, regulatory reliance, IVD reclassification, and Special Access Route (SAR) registration initiatives. Read the
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