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Philippines: Guidelines for the Disposal of Forfeited Radio Communications Equipment

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

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

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)

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

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

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

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

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

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

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

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

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

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

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)

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

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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Nord Pacific Medical Partners with Institute for Biotechnology and Medicine Industry (IBMI) for the Taiwan Healthcare+ Expo 2025

Taipei, Taiwan – 11/08/2025 — Andaman Medical’s affiliate, Nord Pacific Medical has been invited by the Institute for Biotechnology and Medicine Industry (IBMI) to serve as a strategic partner for the Taiwan Healthcare+ Expo 2025. Through this partnership, Nord Pacific Medical will advocate for international medical device and IVD manufacturers, in collaboration with Andaman Medical.This

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Staying Ahead in Southeast Asia’s Fast-Moving Medical Device Market

Southeast Asia’s medical device and IVD sectors are racing forward, and in this competitive environment, speed to market is no longer optional, it is essential. The region’s IVD market alone is valued at approximately USD 4.37 billion in 2024 and is on track to reach USD 8.04 billion by 2033, growing at a CAGR of

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Thailand: FDA Announces Updated Prescribed Forms for Medical Device License and Notification Renewals

On July 22, 2025, the Thai Food and Drug Administration (Thai FDA) introduced updated prescribed forms for the renewal of medical device notifications and licenses, replacing the previous versions outlined in the 2021 announcements. This update is issued under Section 12 of the relevant Ministerial Regulations and ensures that the forms align more closely with

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Thailand: Exemption of Specific Documents for Medical Device License or Notification Renewals

In an effort to ease the renewal process for medical device licenses and notifications, the Thai FDA has introduced exemptions for certain documents and information, which took effect on the 22nd of July 2025.  This change applies to licensees or notifiers who face difficulties in renewing their licenses or notifications. The decision comes under Section

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Malaysia: Implementation of the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I)

On July 30, 2025, the Medical Device Authority (MDA) released an official announcement regarding the Implementation of the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I). The programme is a result of a Memorandum of Understanding (MoU) signed between the MDA (Malaysia) and the National Medical Products Administration (NMPA) (China), aligning with the principles

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Indonesia: Deactivation of e-Catalogue Version 5 for Construction and Healthcare Showcases – Circular Letter No. 2/202

On July 22, 2025, the Head of the National Public Procurement Agency (Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah – LKPP) issued Circular Letter No. 2 of 2025 concerning the Deactivation of the e-Catalogue Version 5 for Construction and Health Showcases. To view the official document (Bahasa Indonesia only), refer to:Circular Letter No. 2 of 2025 –

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Thailand: Thai FDA Announces System for Medical Device License and Notification Renewal

On July 23, 2025, the Thai Food and Drug Administration (Thai FDA) announced a new system for the renewal of medical device licenses and notification certificates, to be submitted annually through the SKYNET online platform. To view the official announcement and infographic, refer to:กองควบคุมเครื่องมือแพทย์ (Medical Device Control Division) Key Highlights Annual Renewal Period Medical device

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Thailand: FDA Outlines the Differences Between the “Document Addition System” and “Renewal System” in SkyNet

On July 18, 2025, the Thai Food and Drug Administration (FDA) issued a press release clarifying the differences between the Document Addition System (Upgrade to Full CSDT) and the Renewal System within SkyNet, the regulatory platform for medical device registrations. This clarification is critical for stakeholders managing existing licenses or notification certificates. To view the

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Thailand: Ministry of Public Health Announces Designated Inspection Points for Imported Medical Devices

On July 18, 2025, the Ministry of Public Health, acting on the recommendation of the Medical Device Committee, issued an announcement revising the official list of designated inspection points for imported medical devices. This update repeals and replaces the previous Announcement dated December 14, 2023 (B.E. 2566). To view the official announcement (in Thai), refer

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Vietnam: Draft Circular on National Centralized Procurement List for Medical Devices and Testing Supplies – Feedback Requested

On July 21, 2025, the Vietnam Ministry of Health issued Official Dispatch No. 4755/BYT-HTTB to solicit public and stakeholder feedback on the Draft Circular concerning the issuance of a national centralized procurement list for medical devices and testing supplies. This draft, prepared by the Infrastructure and Medical Device Administration (IMDA), aligns with the provisions of

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Singapore: Guidance on the Component Elements of a Dear Healthcare Professional Letter

On July 2025, the Health Sciences Authority (HSA) released a new revision to existing guidance titled GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter (DHCPL). To view the official guidance document, refer to: GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter Key Highlights New Clause Requirement This

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Indonesia: Medical Equipment Permitted for Retail Distribution

A new regulation was issued by the Minister of Health on 18 July 2025, establishing the criteria for medical devices that may be sold in the retail market. The criteria are as follows: The product holds a valid Distribution License Number (Nomor Izin Edar/NIE) Classified as a low-risk medical device Suitable for use outside of

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Indonesia: Medical Support Devices Inclusion in e-Catalogue Version 6

This process applies to medical support devices that have received a Letter of Notification (Surat Keterangan Informasi Produk/SKP-IP) from the Ministry of Health, stating that the product is not classified as a medical device. These products are used in health services in accordance with their intended function. To view the full list of product categories

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The Future of Medical Devices and IVDs in Southeast Asia banner img v1

The Future of Medical Devices and IVDs in Southeast Asia

Southeast Asia’s healthcare industry is evolving fast, and the medical device and IVD sectors are at the heart of this transformation. The region’s medical device market is expected to surpass $12.2 billion by 2025, with cardiology devices emerging as the largest segment, projected to reach $1.96 billion this year. Key drivers of growth include the

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