September 2025

Philippines: Guidelines for the Disposal of Forfeited Radio Communications Equipment

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On September 19, 2025, the National Telecommunications Commission (NTC) issued Memorandum Circular No. 002-09-2025, “Guidelines for the Disposal of Forfeited Radio Communications Equipment, Customer Premises Equipment and Its Accessories.” The circular is issued under the authority of Act No. 3846 (as amended), Executive Order No. 546, NTC Memorandum Circular No. 3-3-97, and other applicable laws […]

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Malaysia: Second Edition of Guidance Document MDA/GD/0070 Implemented

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On September 12, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition of Guidance Document MDA/GD/0070. This updated guide provides establishments, manufacturers, and authorised representatives with revised instructions for medical device registration and abridged conformity assessment via the MeDC@St system. The revisions align with the Medical Device Act 2012 (Act 737), the

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Malaysia: Implementation of the Second Edition Guidance Document MDA/GD/0068

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On September 12, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition of Guidance Document MDA/GD/0068: Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification. This update aims to improve consistency, transparency, and efficiency of conformity assessments under Malaysia’s medical device regulatory framework. Scope Guidance document detailing instructions

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Malaysia: Malaysia Joins the Medical Device Single Audit Program (MDSAP)

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On 19 September 2025, the Medical Device Authority (MDA) of Malaysia announced that Malaysia has officially become an Affiliate Member of the Medical Device Single Audit Program (MDSAP). This significant milestone aligns Malaysia with other participating regulatory authorities and strengthens its position in the global medical device regulatory framework. Scope The announcement marks Malaysia’s formal

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Thailand: Announcement on the Reporting of Production, Import, or Sale of Medical Devices

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On September 5, 2025, the Ministry of Public Health of Thailand released a draft announcement regarding the Criteria, Methods, and Conditions for Recording and Reporting the Production, Import, or Sale of Medical Devices. This draft is issued under the authority of the Medical Device Act B.E. 2551, as amended, and is intended to replace the

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Thailand: Exemption for Advertising Medical Devices at Academic Exhibitions and Conferences

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On September 2, 2025, the Ministry of Public Health released an announcement concerning the Advertising of Medical Devices in National or International Academic Exhibitions or Academic Conferences That Are Exempt from Needing Permission B.E. 2568.  The regulation, issued under the authority of the Medical Device Act B.E. 2551, sets out specific conditions under which advertising

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Singapore: GL-08 Regulatory Guidelines for Laboratory Developed Tests (LDTs) Revision 2

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On September 4, 2025, the Health Sciences Authority (HSA) of Singapore issued Revision 2 of GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs). This revision aims to strike a balance between strengthening ethical safeguards for patients and easing operational demands on laboratories. Scope Guidance revision covering the use, regulation, and compliance obligations of Laboratory Developed

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Singapore: GN-35 Guidance on Special Access Routes (SAR) Revision 5

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On September 4, 2025, the Health Sciences Authority (HSA) of Singapore issued Revision 5 of GN-35: Guidance on Special Access Routes (SAR) for medical devices. This latest update introduces enhanced regulatory clarity and fully digitalised processes to facilitate access to unregistered medical devices in Singapore. Scope Summary results of the updated GN-35 guidance on Special

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Regulatory Harmonisation: Shaping the Future of Medical Devices in Southeast Asia

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In 2025, regulatory harmonisation across Southeast Asia continues to gain momentum, led by the ASEAN Medical Device Directive (AMDD). This initiative is reshaping the region’s medical device landscape by establishing more unified standards that support both patient safety and streamlined market access. Key Trends Driving This Transformation: AMDD in Action The AMDD seeks to align

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Malaysia: Futurise Lead RegTalk 2025 – AI Medical Devices in Malaysia: Balancing Innovation and Safety

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On 28 August 2025, Futurise Sdn Bhd, a wholly-owned subsidiary of Cyberview Sdn Bhd under the Ministry of Finance, in collaboration with the Medical Device Authority (MDA), hosted RegTalk 2025: AI Medical Devices in Malaysia – Balancing Innovation and Safety at the Siemens Healthineers Experience Center, Kuala Lumpur. The session brought together regulators, industry leaders,

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Indonesia: Socialization of Government Regulation No. 28 of 2025 on Risk-Based Business Licensing for Medical Device Distribution Facilities

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On June 5, 2025, the Ministry of Health of Indonesia issued Government Regulation No. 28 of 2025 concerning the Implementation of Risk-Based Business Licensing for Medical Device Distribution Facilities. Scope Summary results of the Socialization of the Indonesian Ministry of Health. Key Points In Appendix II of Government Regulation No. 28 of 2025, it is

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Indonesia: MOH Notification on Medical Device Product Display in E-Catalogue Version 6

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Notification Letter No. BJ.01.03/A.VI/6405/2025 regarding the transition of medical device product display to Electronic Catalogue (E-Catalogue) Version 6. This action follows Circular Letter No. 2 of 2025 from the Head of the Policy Institute for Procurement of Goods/Services (LKPP), which stipulates that E-Catalogue Version 5 for the health showcase will be deactivated on September 30,

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Malaysia: Infographic on Implementation Requirements on Quality Management System (QMS) and Traceability Form

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On August 18, 2025, the Medical Device Authority of Malaysia (MDA) has updated the infographic (only editorial changes) related to REQUIREMENTS ON QUALITY MANAGEMENT SYSTEM (QMS) AND TRACEABILITY FORM applies to new medical device applications and re-registration medical device applications submitted from 1 January 2024. This infographic refers to the announcement on 4th August 2023

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Philippines: DOH Extends Suspension of FDA’s New Fees and Charges Under AO No. 2024-0016

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On September 5, 2025, the Department of Health (DOH) issued Department Circular No. 2025-0328, officially extending the temporary suspension of Administrative Order (AO) No. 2024-0016 for an additional sixty (60) working days.  AO No. 2024-0016 introduces a new schedule of fees and charges for services provided by the Food and Drug Administration (FDA). This extension

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Thailand: FDA Issues Updated List of Experts for Evaluating Academic Documents for Medical Devices (Issue No. 13, B.E. 2568 / 2025)

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On August 20, 2025, the Thai Food and Drug Administration (Thai FDA) issued Announcement (Issue No. 13) B.E. 2568 (2025), updating the list of experts, expert organizations, government agencies, and private organizations—both domestic and foreign—authorized to perform duties in evaluating academic documents for medical devices. This announcement is made under Section 35/2, Paragraph One of

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Indonesia: MOH Issues Follow-up on Transition of Medical Devices and Pharmaceuticals in the e-Catalogue System

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On August 20, 2025, the Ministry of Health (MOH) issued Notification Letter No. BJ.02.03/A.VI/5997/2025 concerning the follow-up transition of medical devices and pharmaceuticals in the e-Catalogue system. This follows the Circular Letter of the Head of the National Public Procurement Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa) No. 2 of 2025 dated July 22, 2025, regarding

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