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
On July 21, 2025, the Vietnam Ministry of Health issued Official Dispatch No. 4755/BYT-HTTB to solicit public and stakeholder feedback on the Draft Circular concerning the issuance of a national centralized procurement list for medical devices and testing supplies. This draft, prepared by the Infrastructure and Medical Device Administration (IMDA), aligns with the provisions of
On July 16, 2025, the Ministry of Health Malaysia announced the launch of the Medical Device Regulatory Reliance Programme with China. This landmark initiative, revealed during the HIMSS Asia-Pacific Health Conference & Exhibition 2025 in Kuala Lumpur, marks a strategic breakthrough in accelerating patient access to safe and innovative medical technologies. The programme builds on
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
Singapore: Guidance on the Component Elements of a Dear Healthcare Professional Letter Read More »
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
Indonesia: Medical Equipment Permitted for Retail Distribution Read More »
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
Indonesia: Medical Support Devices Inclusion in e-Catalogue Version 6 Read More »
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
The Future of Medical Devices and IVDs in Southeast Asia Read More »
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:
Thailand: FDA Clarifies Smartwatch Classification as Medical Devices Read More »
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
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
Vietnam: MOH Announces Preparatory Steps for 2025 Medical Device Dialogue Conference Read More »
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
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
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.
Indonesia: MoH Extends Product Listing Period for e-Catalogue Version 5 Read More »
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