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
On March 3, 2025, the Food and Drug Administration (FDA) issued Advisory No. 2025-0140, reiterating the official contact details and the process for submitting feedback, complaints, and specific concerns. This aims to ensure that all communications are directed to the appropriate departments for timely and proper responses, as referenced in
The Ministry of Communication and Digital has updated the Minister of Communication and Informatics Regulation Number 2 of 2023 concerning the use of radio frequency spectrum based on class permits. The followings are the highlighted amendment: 1. Radiofrequency spectrum based on class permits for a group of telecommunications equipment
The Food and Drug Administration (FDA) of the Philippines has announced an extension to the renewal application filing period for the License to Operate (LTO), as detailed in FDA Advisory No. 2025-0095. Effective February 17, 2025, stakeholders may submit renewal applications 180 days before their LTO expiration date, replacing the
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
