Insights-2025

Administrative Order (AO) 2025-0030 was issued by the Philippines Department of Health to formally adopt and implement the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD). The AO establishes the mandatory post-market surveillance framework for medical devices in the Philippines to ensure continued safety, performance and quality following […]

The Food and Drug Administration (FDA) issued FDA Advisory No. 2026-0274 announcing the designation of an Officer of the Day (OOD) at the Food and Drug Action Center (FDAC). This initiative aims to ensure the continuous, efficient, and timely handling of urgent regulatory concerns, public inquiries, and emergency cases within the Food and Drug Administration

The Food and Drug Administration (FDA) of the Philippines has issued FDA Circular No. 2025-007, providing detailed guidance on the submission of initial Certificate of Medical Device Notification (CMDN) applications, monitoring application status, and downloading approved CMDNs via the FDA eServices Portal System. This Circular formalizes the transition of CMDN initial application processing from the

The Philippine Department of Health (DOH) has issued Department Circular (DC) No. 2025-0574, further extending the suspension of the implementation of Administrative Order (AO) No. 2024-0016, which outlines the revised schedule of fees and charges of the Food and Drug Administration (FDA). The newly released circular continues the temporary halt on the implementation of the

The Philippine Food and Drug Administration (FDA) has issued FDA Circular No. 2025-006, announcing the implementation of an Online User Account Registration and Renewal System within the FDA eServices Platform. This circular establishes a centralized and automated system for the creation, activation, renewal, and management of user accounts across all FDA online portals. The circular

The Food and Drug Administration (FDA) has published a draft circular for comments outlining the proposed Operational Procedures and Requirements for the Application of a Sales Promotion Permit for FDA-regulated health products. The draft aims to establish a streamlined and harmonized application process for sales promotion campaigns and is currently open for public comment. Read

The Food and Drug Administration (FDA) of the Philippines has issued updated guidelines for applying for a Compassionate Special Permit (CSP), enabling access to pharmaceutical products and medical devices that are not registered in the Philippines but are necessary for restricted, compassionate use. This Order aims to facilitate access to critical therapeutic interventions in urgent

The Food and Drug Administration (FDA) of the Philippines has released a draft Circular titled “Guidelines on the Inspection of Medical Device Establishments” to enhance regulatory oversight and ensure continued compliance with safety and quality standards. This establishes uniform inspection procedures, documentary requirements, and evaluation criteria for manufacturers, traders, distributors, and retailers of medical devices,

On September 19, 2025, the Department of Health (DOH) issued Administrative Order No. 2025-0020, “Rescission of Administrative Order No. 2021-0038 dated June 11, 2021, titled ‘Framework for the Philippine Essential Medical Devices List and Price Reference Index.’” The DOH rescinded the 2021 framework to adopt a more dynamic approach in ensuring the availability of quality

On September 19, 2025, the National Telecommunications Commission (NTC) issued Memorandum Circular No. 002-09-2025, “Guidelines for the Disposal of Forfeited Radio Communications Equipment, Customer Premises Equipment and Its Accessories.” The circular is issued under the authority of Act No. 3846 (as amended), Executive Order No. 546, NTC Memorandum Circular No. 3-3-97, and other applicable laws

On September 5, 2025, the Department of Health (DOH) issued Department Circular No. 2025-0328, officially extending the temporary suspension of Administrative Order (AO) No. 2024-0016 for an additional sixty (60) working days.  AO No. 2024-0016 introduces a new schedule of fees and charges for services provided by the Food and Drug Administration (FDA). This extension

The Food and Drug Administration (FDA) informs its stakeholders that effective immediately, all applications for renewal of License to Operate (LTO) shall revert to the prescribed renewal period of ninety (90) calendar days prior to its expiration, following Administrative Order 2024-0015, titled “Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of