March 2025

Philippines: FDA Advisory No. 2025-0368 on Operating Periods of FDA ePortal

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 improving online services and supporting […]

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Malaysia: First Edition Guidance Document on Importation of Medical Devices for Re-Export (IRE)

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, and compliance obligations. Key Highlights

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Indonesia: Temporary Closure of Licensing System During Eid al-Fitr 1446 H Joint Leave

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 Device Licensing System: https://regalkes.kemkes.go.id/ Other

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Philippines: FDA Temporarily Suspends CDRRHR Telephone Lines Due to Facility Maintenance

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 and the public are advised

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Singapore: Public Consultation on Best Practices Guide for Medical Device Cybersecurity

The Health Sciences Authority (HSA) of Singapore has released a draft guidance document titled Best Practices Guide for Medical Device Cybersecurity for industry stakeholders’ consultation.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 during the software development phase.

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Singapore: Missing Safety Alerts for Smartphone-Compatible Diabetes Devices

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 insulin level fluctuations, potentially leading

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Philippines: Notice of Virtual Public Consultation on Good Storage and Distribution Practices for Medical Devices

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 will be open to representatives

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Philippines: New Email Addresses for Health Product Recalls Announced by FDA

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 Center (FDAC) at info@fda.gov.ph. Additionally,

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Philippines: Reiteration of Contact Details and Process for Feedback, Complaints, and Specific Concerns to the Food and Drug Administration

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 FDA Circular 2020-2026. Feedback and

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Indonesia: Amendments to the Regulation on Radio Frequency Spectrum Use Under Class Permits

  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 and/or telecommunication devices. Changes are

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Philippines: Interim Extension of Renewal Application Filing Period for License to Operate (LTO)

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 previous 90-day requirement. This interim

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