Regulatory Updates

Thailand: Verification and Validation Guidelines for Alcohol-Containing Products Intended for Disinfecting Purposes for Humans, Animals, and Medical Devices

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

Philippines: Publication and Filing Details of DOH Administrative Order No. 2025-0030

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

Philippines: Guidelines on the Use of the “eSUMBONG” System Within the New FDA Website

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

Singapore: Software Medical Devices, IVDs, SAR and Registration Initiatives

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

Thailand: Thai FDA Updates Establishment Registration Form

The Thai Food and Drug Administration (FDA) has announced updates to the establishment registration form for the manufacturing, import, and sale of medical devices. This revision enhances regulatory oversight in line with the digital age, aiming to cover new technologies, particularly Standalone Medical Software, while reducing bureaucratic steps for entrepreneurs

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