On March 31, 2025, the Food and Drug Administration (FDA) of the Philippines released a draft circular titled “Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration”. The draft circular aims to establish effective recall procedures for authorized health products regulated by the FDA
Register your medical device in the Philippines On March 21, 2025, the Food and Drug Administration (FDA) of the Philippines issued FDA Advisory No. 2025-0368, notifying stakeholders of updates to the operating periods of the FDA ePortal system. This change is part of ongoing system maintenance and upgrades aimed at
On March 11, 2025, the Medical Device Authority (MDA) of Malaysia released the First Edition Guidance Document MDA/GD/0069 titled “Importation of Medical Devices for Re-Export (IRE).” This document provides clarity on the procedures and requirements for importing medical devices into Malaysia for re-export purposes, covering aspects such as approvals, exemptions,
The Ministry of Health of Indonesia has announced a temporary closure of the medical device and Household Health Device (PKRT) licensing system in observance of the Eid al-Fitr 1446 H holiday and collective Joint Leave. From March 28 to April 7, 2025, the following systems will be temporarily unavailable: Medical
The Food and Drug Administration (FDA) announces that the telephone numbers for the Center for Device Regulation, Radiation Health, and Research (CDRRHR) are suspended from March 4, 2025, to March 28, 2025, or until the completion of necessary roofing installation at their facilities. Alternative Contact Methods During this period, stakeholders
The Health Sciences Authority (HSA) of Singapore has released a draft guidance document titled Best Practices Guide for Medical Device Cybersecurity for industry stakeholders’ consultation. Key Highlights Scope and Purpose: Intended for medical device manufacturers and healthcare providers. Establishes general cybersecurity principles, particularly advocating for a “Secure by Design” approach
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