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
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
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.
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