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The Health Sciences Authority (HSA) of Singapore has released a draft guidance document titled Best Practices Guide for Medical Device Cybersecurity for industry stakeholders’ consultation.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
The Health Sciences Authority (HSA) Singapore has issued an advisory to users of app-enabled medical devices, including continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems, and other diabetes devices. This advisory is based on overseas cases where notification alerts failed to activate on users’ smartphones during glucose and/or
On March 27, 2025, the FDA, through the Center for Device Regulation, Radiation Health, and Research (CDRRHR), will hold a Virtual Public Consultation to present the proposed Administrative Order (AO) titled “Guidelines for Good Storage and Distribution Practices for Medical Devices.” The consultation will be conducted via Microsoft Teams and
On March 3, 2025, the Food and Drug Administration (FDA) issued FDA Advisory No. 2025-0139 announcing new email addresses for submitting notifications and reports on health product recalls. Market Authorization Holders (MAHs) must promptly notify the FDA and submit the necessary reports and information to the Food and Drug Action
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