June 2025
Vietnam: MOH Announces Preparatory Steps for 2025 Medical Device Dialogue Conference
The Vietnam Ministry of Health (MOH) has released Notification No. 3776/BYT-HTTB, announcing the upcoming 2025 Dialogue Conference between the MOH and medical device businesses. The event is scheduled to take place in early August 2025 in Nha Trang City, Khanh Hoa Province. This annual dialogue offers stakeholders an important platform to raise regulatory concerns, provide
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Malaysia: New Login Feature via MyDigital ID
The Medical Device Authority (MDA) informed all users that, starting 23 June 2025, a new login feature via MyDigital ID will be supported in MedC@St 2.0+. This enhancement aims to strengthen account security, protect user access, and reduce the risk of identity fraud. To log in or view the system, visit: MedC@St Login Page To
Malaysia: MDA Releases Third Edition of ASEAN Harmonised Medical Device Classification Guidance (MDA/GD/0062)
The Medical Device Authority (MDA) has issued the Third Edition of the Guidance Document MDA/GD/0062: Harmonised Classification of Medical Devices in ASEAN. This document supersedes previous editions and provides an updated list of harmonised risk classifications for general and in-vitro diagnostic (IVD) medical devices, as agreed by the ASEAN Medical Device Committee (AMDC). The classification
Malaysia: MDA Releases Third Edition of Harmonised Borderline Products in ASEAN Guidance (MDA/GD/0063)
The Medical Device Authority (MDA) has published the Third Edition of MDA/GD/0063: Harmonised Borderline Products in ASEAN, which outlines product categories that fall within or outside the scope of medical device regulation across ASEAN member states. This guidance serves as a key reference to determine whether a product is regulated as a medical device or
Indonesia: Maintenance of the Medical Device and Household Health Product Licensing System
The Ministry of Health has announced the upcoming maintenance of the Medical Device and Household Health Product Licensing System (digisignalkes.kemkes.go.id). The maintenance will temporarily affect system access and licensing processes for Medical Devices and Household Health Products, including IDAK and Statement Letters. To read more, refer to the official announcement: System Maintenance [PDF] Effectivity June
Malaysia: MDA Introduces Enhanced Dispute Resolution Process for Medical Device Classification
The Medical Device Authority (MDA) has announced a new enhanced process to facilitate the resolution of classification risk disputes between Establishments and Conformity Assessment Bodies (CABs). This initiative aligns with the Medical Device Act 2012 (Act 737) and aims to improve consistency and clarity in determining the appropriate classification for both General Medical Devices (GMD)
Malaysia: MDA Announcement Re: Updated Approach for New Registrations with Expired EC Certificates
The Medical Device Authority (MDA) has issued an updated regulatory approach regarding the use of expired EC Certificates for the new registration of medical devices in Malaysia. This revision is in response to ongoing challenges associated with the transition to the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
Malaysia: MDA Announcement Re: Medical Device Re-Registration Must Be Submitted One Year Before Expiry via MeDC@St 2.0+
The Medical Device Authority (MDA) reminds all licensed establishments of the official requirements for re-registering medical devices in Malaysia, in accordance with the latest Guidance Document MDA/GD/0070 titled “Guide for Medical Device Establishment Conformity Assessment by Way of Verification & Submission of Medical Device Registration in MeDC@St.” Under this guidance, re-registration must be conducted via
Malaysia: MDA Media Statement Re: Online Advertisement Monitoring – Year 2024
On 3 June 2025, the Medical Device Authority (MDA) issued a media statement highlighting its ongoing efforts to ensure that online advertisements of medical devices comply with regulatory requirements under the Medical Device Act 2012 (Act 737). The objective is to safeguard public health and safety by preventing the sale and advertisement of unregistered medical
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Philippines: DOH Advisory Re: Temporary 60-Working Day Suspension of AO 2024-0016 on New FDA Fees and Charges
The Department of Health (DOH) has issued Department Circular No. 2025-0240, temporarily suspending the implementation of Administrative Order (AO) No. 2024-0016 entitled “Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration,” in response to feedback and concerns raised by various sectors and stakeholders. Under this directive, the implementation
Singapore: HSA and MFDS Publish Guiding Principles for Clinical Trials of Machine Learning-enabled Medical Devices (MLMD)
In support of digital health product innovation, the Health Sciences Authority (HSA), Singapore, collaborated with the Ministry of Food and Drug Safety (MFDS), Korea, to publish guiding principles for conducting clinical trials of machine learning-enabled medical devices (MLMD). This guideline version is effective from 11 December 2024. Core Guiding Principles for MLMD Clinical Trials Clinical
Singapore: HSA to Launch New SHARE Portal for Medical Device Regulatory Transactions
Online medical device transactions and submissions have been conducted via the Medical Device Information and Communication System (MEDICS) with the Health Sciences Authority (HSA), Singapore. On 21 May 2025, an industry briefing session announced the replacement of MEDICS with the Singapore Health Product Access and Regulatory E-System (SHARE). SHARE is a one-stop digital portal for
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Singapore: HSA Notification Re: Official Launch of MDSAP Website
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
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
Thailand: Thai FDA Infographic Re: Document Supplementation System for Upgrading Submission Type from Partial (1 or 2) or Abridged to Full CSDT
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
Vietnam: Relocation of Infrastructure and Medical Device Administration
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.
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
