Indonesia
Medical devices and IVDs are regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class
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
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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Thailand: FDA Clarifies Smartwatch Classification as Medical Devices
On July 03, 2025, the Thai Food and Drug Administration (FDA) released an infographic via their official Facebook page to clarify which smartwatch functionalities fall under the classification of medical devices. This guidance is important for stakeholders involved in the production, import, and sale of smartwatches in Thailand. To view the official infographic, refer to:
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Singapore: GN-21 – Guidance on Change Notification for Registered Medical Devices Revised
On July 2025, a new revision to the existing guidance GN-21: Guidance on Change Notification for Registered Medical Devices was released. This guidance outlines the requirements for Change Notifications for Medical Devices registered on the Singapore Medical Device Register (SMDR). To view the official guidance, refer to: GN-21: Guidance on Change Notification for Registered Medical
Vietnam: MOH Announces Preparatory Steps for 2025 Medical Device Dialogue Conference
On 30 June 2025, the Vietnam Ministry of Finance issued Circular No. 64/2025/TT-BTC, announcing a reduction in government fees and charges for certain administrative procedures, including those within the medical sector. This initiative aims to support businesses and citizens by reducing financial burdens. To view the official circular, refer to: [Circular No. 64-2025-TT-BTC.pdf] Key Highlights
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Philippines: FDA Advisory No. 2025-0095-A || Lifting of the Advisory on the Interim Extension of Renewal Application Period of LTO Prior to Expiration of Validity Under FDA Advisory No. 2025-0095
The Food and Drug Administration (FDA) informs its stakeholders that effective immediately, all applications for renewal of License to Operate (LTO) shall revert to the prescribed renewal period of ninety (90) calendar days prior to its expiration, following Administrative Order 2024-0015, titled “Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of
Philippines: FDA Advisory No. 2025-0729 || Guidelines on the Re-issuance of Order of Payment
The Food and Drug Administration (FDA) has issued an advisory regarding the Guidelines on the Re-issuance of Order of Payment following the temporary suspension of AO No. 2024-0016. Applications filed during the effectivity of the said AO but not yet paid may request a reissued Order of Payment reflecting the previous (lower) fees. Applications filed during the effectivity
Indonesia: MoH Extends Product Listing Period for e-Catalogue Version 5
The Ministry of Health (MoH) of Indonesia has officially extended the product listing period in the Sectoral Healthcare Facility Showcase on e-Catalogue Version 5. This update follows the recent socialization session conducted on June 25, 2025. Read the Announcement (Indonesian): Updated Schedule – e-Catalogue V5 Listing Extension Please note: The information is provided in Indonesian.
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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
