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
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
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:
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