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Singapore: HSA Notification Re: Official Launch of MDSAP Website

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An official observer of the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council (RAC), the Health Sciences Authority (HSA), Singapore, informs that the official website has been launched at https://www.mdsap.global/. MDSAP allows a recognized Auditing Organization (AO) to conduct a single regulatory audit of a medical device manufacturer that satisfies the requirements of multiple […]

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Singapore: HSA Public Consultation Re: Proposed Exemption from Manufacturer’s Licensing and Product Registration Requirements for AI-SaMD in Public Healthcare

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The Health Sciences Authority (HSA), Singapore, seeks public consultation on exemptions from manufacturer licensing and product registration requirements for Artificial Intelligence (AI) – Software as Medical Devices (SaMDs) developed by MOH Holdings Pte Ltd (MOHT), Synapxe Pte Ltd (Synapxe), and public healthcare clusters/institutions. Scope of AI-SaMD for Proposed Exemptions Class A and B Developed under

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Thailand: Thai FDA Infographic Re: Document Supplementation System for Upgrading Submission Type from Partial (1 or 2) or Abridged to Full CSDT

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The Thai Food and Drug Administration (FDA), through the Medical Device Control Division, has developed a document supplementation system to facilitate the upgrading of submission types from Partial 1, Partial 2, or Abridged to Full Common Submission Dossier Template (CSDT). This system is accessible via the TFDA’s Skynet platform and aims to streamline the upgrading

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Vietnam: Relocation of Infrastructure and Medical Device Administration

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On May 21, 2025, the Vietnam Ministry of Health issued Notification No. 387/TB-HTTB, officially announcing the relocation of the Infrastructure and Medical Device Administration (IMDA) office. The new IMDA office is now located on the 7th, 8th, and 9th floors of the Ministry of Health’s 9-storey building at Alley 1, Lane 135 Nui Truc, Ba

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Philippines: Department of Health approves the recommendation of Food and Drug Administration to temporarily suspend New Regulatory Fees.

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The Department of Health (DOH) posted an advisory on its DOH FB page last May 30, 2025, informing the public of its approval for the temporary suspension of FDA New Regulatory Fees. The approved FDA memorandum with Subject: Recommendation to temporarily suspend the implementation of Administrative Order 2024-0016: Implementing Guidelines on the New Schedule of

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Andaman Medical Joins TMBIA as a Patron Member, Strengthening Commitment to Regulatory Excellence Across Asia-Pacific

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We’re excited to announce our continued partnership with the Taiwan Medical and Biotech Industry Association (TMBIA) as a proud Patron Member, reinforcing our commitment to advancing medical device innovation across Asia-Pacific markets. A Partnership Built on Shared Vision As one of only 19 Patron Members supporting TMBIA’s mission, Andaman Medical joins an elite group of

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Malaysia: MDA Notification: Advisory on the Use of Malaria Test Kits

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On March 31, 2025, the World Health Organization (WHO) issued an advisory regarding performance concerns with certain malaria rapid diagnostic test kits (RDTs). WHO has received multiple reports indicating faint positive test lines observed in patients confirmed to have malaria, potentially affecting test reliability across several countries using these kits. In this regard, the Medical

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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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