The Medical Device Authority (MDA) of Malaysia has officially gazetted the Medical Device (Amendment) Regulations 2025 [P.U. (A) 330] on September 11, 2025. This amendment revises the fee structure under the Fifth Schedule of the Medical Device Regulations 2012 [P.U. (A) 500/2012] for the registration of Class A medical devices, effective January 1, 2026. To […]
Malaysia: Update on Fees for Class A Medical Devices Read More »
The Medical Device Authority (MDA) of Malaysia announced that Malaysia has been officially recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP) by the MDSAP Regulatory Authority Council (RAC), effective September 16, 2025. This milestone aligns Malaysia with other participating regulatory authorities and strengthens its position in the global medical device
On September 30, 2025, the Secretariat General of the Ministry of Health of Indonesia issued a new Notification Letter titled “Deactivation of Electronic Catalogue Version 5”. This update follows the Letter from the Director of Digital Market Procurement LKPP and the Circular Letter from the Head of LKPP Number 2 of 2025 concerning the Deactivation
Indonesia: Deactivation of Electronic Catalogue Version 5 Read More »
On September 19, 2025, the Department of Health (DOH) issued Administrative Order No. 2025-0020, “Rescission of Administrative Order No. 2021-0038 dated June 11, 2021, titled ‘Framework for the Philippine Essential Medical Devices List and Price Reference Index.’” The DOH rescinded the 2021 framework to adopt a more dynamic approach in ensuring the availability of quality
Philippines: Rescission of Administrative Order on Essential Medical Devices Framework Read More »
The Thai FDA has published an infographic and FAQs detailing the renewal process for five types of medical device licenses. The guidance provides step-by-step procedures, timelines, fees, and frequently asked questions to support registrants in maintaining compliance. To view the official announcement: Infographic- กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai). FAQs: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official
Thailand: FDA Infographic on Renewal Process and FAQs for Medical Device Licenses Read More »
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
Philippines: Guidelines for the Disposal of Forfeited Radio Communications Equipment Read More »
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
Malaysia: Second Edition of Guidance Document MDA/GD/0070 Implemented Read More »
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
Malaysia: Implementation of the Second Edition Guidance Document MDA/GD/0068 Read More »
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
Malaysia: Malaysia Joins the Medical Device Single Audit Program (MDSAP) Read More »
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
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
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
Singapore: GL-08 Regulatory Guidelines for Laboratory Developed Tests (LDTs) Revision 2 Read More »
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
Singapore: GN-35 Guidance on Special Access Routes (SAR) Revision 5 Read More »
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
Regulatory Harmonisation: Shaping the Future of Medical Devices in Southeast Asia Read More »
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,
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
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,
Indonesia: MOH Notification on Medical Device Product Display in E-Catalogue Version 6 Read More »
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
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
Philippines: DOH Extends Suspension of FDA’s New Fees and Charges Under AO No. 2024-0016 Read More »
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
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
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
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
Staying Ahead in Southeast Asia’s Fast-Moving Medical Device Market Read More »
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
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
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
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 –
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
Thailand: Thai FDA Announces System for Medical Device License and Notification Renewal Read More »
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
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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