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Thailand: The Implementation of the Electronic Certificate System (e-Certificate)

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On April 17, 2025, the Food and Drug Administration (FDA) recognized the importance of enhancing competitiveness by developing public administration systems to provide efficient services to the public. Therefore, the electronic certificate system (e-Certificate) has been developed to meet the needs of entrepreneurs, allowing them to access services online anytime and anywhere. This initiative aligns with […]

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Malaysia: Implementation of Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries

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On 26 March 2025, the Medical Device Authority (MDA) announced the implementation of Circular Letter No. 1/2025, which supersedes Circular Letter No. 2/2014 regarding conformity assessment procedures for medical devices approved by recognised foreign regulatory authorities. This new circular was approved by the MDA Board and Top Management and took effect on 11 March 2025.

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Malaysia: MDA Seeks Public Comment on Draft Guidelines for Export-Only Medical Devices

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The Medical Device Authority (MDA) of Malaysia has released the Second Edition Guidance Document, MDA/GD/0051 April 2025: Medical Device for the Purpose of Export Only, for public comment. This document is intended to replace the previous edition MDA/GD/0051 April 2019: Notification of Export Only Medical Device. The revised guidance provides comprehensive guidance on the procedures and

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Malaysia: MDA Seeks Public Comment on Draft Guidelines for Importing or Supplying Unregistered Medical Devices Through Special Access Exemptions Application

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The Medical Device Authority (MDA) of Malaysia has released the Second Edition Guidance Document, MDA/GD/0043 Mei 2025: Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, for public comment.  This document is intended to replace the previous edition, MDA/GD/0043 May 2020: Special Access – Notification – General Requirements. The revised guidance provides

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Indonesia: Updated List of Approved Labs for Testing Medical Devices and Health Supplies under SNI ISO/IEC 17025:2017

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On 21 April 2025, the Directorate General of Pharmaceuticals and Medical Devices of the Ministry of Health of Indonesia issued a new Circular Letter updating the approved list of laboratories for testing medical devices and health supplies under the SNI ISO/IEC 17025:2017 standard. The updated regulation is detailed in Circular Letter Number HK.02.02/E/673/2025. Key Highlights

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Malaysia: MDA Announces Prohibition of Online Sale of Optical Devices and Contact Lenses

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On 25 March 2025, the Medical Device Authority (MDA) of Malaysia issued a press release announcing a prohibition on the online sale of optical devices and contact lenses. These products are designated as prescribed medical devices under the Medical Device Act 2012 (Act 737) and the Opticians Act 1991 (Act 469). Only registered opticians or

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Malaysia: Implementation of Medical Device Import Permit 

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On 26 March 2025, the Medical Device Authority (MDA) of Malaysia officially announced the implementation of a Medical Device Import Permit (IP) requirement under the Customs (Prohibition of Import) Order 2023. This new regulation mandates that importers obtain an Import Permit for bringing medical devices into Malaysia. The MDA has been designated as the responsible

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Malaysia: MDA Announces Transition to Online Product Classification Application & Implementation of Validity Period for Product Classification Letter

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On April 8, 2025, the Medical Device Authority (MDA) of Malaysia released two important regulatory updates to enhance efficiency, strengthen compliance, and improve the overall submission process for product classification. These updates are effective starting May 1, 2025. The first update mandates the full transition to online submission for product classification applications. The second introduces

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Thailand: (Draft) Criteria, Methods, and Conditions on Labeling and Documentation (IFU) for Medical Devices

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On March 18, 2025, the Ministry of Public Health (MoPH) of Thailand released a draft notification to amend its 2020 regulation on the criteria, methods, and conditions for labeling and documentation of medical devices (B.E. 2563), in alignment with the Medical Device Act B.E. 2551 (2008) and its 2019 amendment. Key Summary: Clause 1 This

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Indonesia: Update in the Listing of Healthcare Facilities in the Ministry of Health’s Sectoral Showcase

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On March 21, 2025, the Ministry of Health announced an update regarding the listing of healthcare facilities in the Sectoral Showcase of the Electronic Catalogue Version 5. This follows the issuance of Circular Letter Number 6432/KA/03/2025, which outlines the transition process for medical device commodities in the procurement system. According to the circular, medical device

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Indonesia: Follow-Up Notification on the Electronic Catalogue Transition to Version 6

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On March 20, 2025, the Indonesian government issued a follow-up notification in accordance with Circular Letter No. 9 of 2024 regarding the transition from Electronic Catalogue Version 5 to Version 6. The updated guidance outlines the deactivation of certain commodities from Version 5 and introduces a phased migration to the enhanced Version 6 platform. This

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Philippines: Draft for Comments || Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration

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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 in the Philippine market. The

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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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  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)

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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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Malaysia: Implementation of Medical Device Regulations on Compounding of Offenses

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On January 15, 2025, the Medical Device Authority (MDA) will begin implementing compounding of offenses under the Medical Device Act 2012 (Act 737). This enforcement is based on the authority granted under Section 71 of Act 737 and the Medical Device (Compounding of Offenses) Regulations 2024, which were officially gazetted last year. Key Highlights Objective

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Thailand: New Guidelines for Change Notification of Medical Device Item Addition or Reduction for Notified and Licensed Non-In Vitro Diagnostic Devices

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On February 10, 2025, the Thai Food and Drug Administration (FDA) released updated guidelines for submitting change notifications related to the addition or reduction of medical device items for non-in-vitro diagnostic (non-IVD) medical devices. These guidelines outline the required documentation for various types of change requests and took effect on January 15, 2025. Key Highlights

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