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
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:
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
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.
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
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
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