The Halal Product Assurance Agency (BPJPH) has issued Decree No. 221 Year 2025 (“the Decree”) titled Procedures for the Registration of Foreign Halal Certificates. This regulation revokes the Decree of the Head of the Halal Product Assurance Agency (BPJPH) No. 90 of 2023. The Decree was promulgated on 15 September 2025 and governs the registration […]
The Medical Device Control Division of the Thai Food and Drug Administration (TFDA) has launched an online search tool that enables public access to a comprehensive list of medical devices regulated under specific Notifications of the Ministry of Public Health (MoH). Scope Summary of the initiative launched by the Thai Food and Drug Administration (TFDA)
Thailand: TFDA Launches Online Search Tools for Medical Devices Read More »
The Vietnam Ministry of Health (MoH) released a draft Circular on 16 October 2025 outlining specific tasks and administrative procedures related to medical device management. The Circular also introduces detailed templates for documents and reports required to comply with the Ministry’s regulations. Scope Summary of the draft Circular issued by the Vietnam Ministry of Health
The Medical Device Authority (MDA), in collaboration with the Universiti Malaya (UM) research team, is conducting a study titled “Barriers, Risks, and Regulations in Malaysia’s Medical Device Industry”. Scope Summary of the online survey conducted jointly by the Medical Device Authority (MDA) and Universiti Malaya (UM) to identify barriers, risks, and opportunities within Malaysia’s medical
The Revision 2 provides updated regulatory guidance for in vitro diagnostic (IVD) analysers and their associated accessories. It focuses on risk classification, grouping, SMDR (Singapore Medical Device Register) listing options, and change notification requirements. Scope Summary of the updated GN-34 Guidance Document for IVD Analysers (Revision 2) issued by the Health Sciences Authority (HSA), Singapore,
Singapore: GN-34 Guidance Document for IVD Analysers (Revision 2) Read More »
The Revision 7 introduces several structural and procedural updates to streamline medical device regulatory submissions. The most significant change is the platform migration from MEDICS to SHARE, marking a complete transition across all application processes. Scope Summary of the updated GN-02 Guidance Document (Revision 7) issued by the Health Sciences Authority (HSA), Singapore, outlining the
Key Highlights Revision 4 reminded applicants that the online submission platform has transited from MEDICS to SHARE. The inclusion of a dedicated Machine Learning documentation section establishes robust expectations for ML-enabled devices, covering model design, training validation protocols, and risk management and others per GL-04 guidelines. Additionally, the new ISO 13485 certification rule mandates accreditation
The Medical Device Authority (MDA) has announced the approval of a minor amendment to Circular Letter No. 1 Year 2025. The revised document is now designated as Circular Letter No. 2 Year 2025 (“the Circular”) and took effect on 30 September 2025. Scope Summary of the latest update issued by the Medical Device Authority
The Medical Device Authority (MDA) has released the draft Seventh Edition of the Guidance Document titled “Requirements for Labelling of Medical Devices” for public consultation. The draft introduces key amendments to the existing labelling framework, including the proposed implementation of electronic labelling (e-labelling) for home-use medical devices, aligning Malaysia’s regulatory approach with international best practices.
Malaysia: Requirements for Labelling of Medical Devices Read More »
The Medical Device Authority (MDA) has published the draft First Edition Guidance Document (PDF) titled “Application for Confirmation Status of Obsolete and Discontinued Medical Device” for public comment. The guidance outlines the eligibility criteria, application procedures, and the responsibilities and obligations of establishments in managing obsolete and discontinued medical devices. To access the guidance document
The medtech landscape across Asia-Pacific continues to evolve rapidly, shaped by shifting regulatory frameworks, economic transitions, and an increased focus on localization, digital health, and market access complexity. Companies operating in the region must adapt quickly to maintain competitiveness, particularly in Southeast Asia’s high-growth healthcare markets. Localisation and Government Push for Onshore Manufacturing Governments across
Medtech Outlook: Navigating Asia-Pacific in 2026 Read More »
The Health Sciences Authority (HSA) and the Singapore Manufacturing Federation (SMF), through its Medical Technology Industry Group (MTIG), have launched an integrated regulatory support ecosystem for Singapore’s MedTech sector. This collaboration combines the SME Centre@SMF’s business advisory services with HSA’s Health Products Regulation Group (HPRG) Innovation Office to shift regulatory processes from reactive compliance to
Singapore: HSA–SMF Partnership Enhances MedTech Regulatory Support and Market Access Read More »
The Food and Drug Administration (FDA) of the Philippines has released a draft Circular titled “Guidelines on the Inspection of Medical Device Establishments” to enhance regulatory oversight and ensure continued compliance with safety and quality standards. This establishes uniform inspection procedures, documentary requirements, and evaluation criteria for manufacturers, traders, distributors, and retailers of medical devices,
Philippines: Guidelines on the Inspection of Medical Device Establishments Read More »
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 »
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